Phase 3 win positions Alumis (NASDAQ: ALMS) psoriasis pill for 2026 NDA
Rhea-AI Filing Summary
Alumis Inc. reported strong Phase 3 results for envudeucitinib, its oral TYK2 inhibitor for moderate-to-severe plaque psoriasis. In the ONWARD1 and ONWARD2 trials, high levels of skin clearance were achieved and deepened through 24 weeks, with meaningful quality-of-life and itch improvements emerging early.
By Week 24, PASI 90 skin clearance rates reached 68.0% and 62.1%, and PASI 100 complete clearance reached 41.0% and 39.5% in envudeucitinib-treated patients. Safety and tolerability were favorable and consistent with Phase 2 data, with mostly mild, manageable side effects and no new safety signals reported.
More than 1,700 adults were enrolled across the parallel Phase 3 trials, which also showed rapid improvement in difficult-to-treat scalp psoriasis. Alumis plans to submit a New Drug Application for envudeucitinib in moderate-to-severe plaque psoriasis in the second half of 2026 and is running an ONWARD3 long-term extension and the LUMUS Phase 2b trial in systemic lupus erythematosus, with topline LUMUS data expected in the third quarter of 2026.
Positive
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Insights
Phase 3 psoriasis data position envudeucitinib as a potentially competitive oral TYK2 therapy ahead of a planned 2026 NDA.
The ONWARD1 and ONWARD2 Phase 3 trials showed high skin-clearance rates for envudeucitinib, with PASI 90 responses of 68.0% and 62.1% and PASI 100 of 41.0% and 39.5% at Week 24. These results, alongside rapid quality-of-life and itch improvements, support a differentiated efficacy profile versus many existing oral options.
Safety through Week 24 was favorable and aligned with earlier Phase 2 data, with mostly mild treatment-emergent adverse events and no new safety signals or tuberculosis reactivation reported. More than 1,700 adults were randomized, which strengthens the robustness of the dataset for regulatory review.
Alumis plans to submit a New Drug Application in the second half of 2026 for moderate-to-severe plaque psoriasis and is collecting longer-term data in ONWARD3. Parallel development in systemic lupus erythematosus via the LUMUS Phase 2b trial, with topline data expected in the third quarter of 2026, could broaden the commercial opportunity if results are supportive.
8-K Event Classification
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Item 8.01 Other Events.
On March 28, 2026, Alumis Inc. (the “Company” or “Alumis”) issued a press release titled “Alumis’ Envudeucitinib Delivers Early and Robust Improvements in Skin Clearance, Quality of Life and Psoriasis Symptoms in Two Phase 3 Trials, Underscoring Its Potential as a Leading Oral Therapy for Plaque Psoriasis”.
The Company is also filing slides presented by the Company at a late-breaking oral presentation at the 2026 American Academy of Dermatology (AAD) Annual Meeting on March 28, 2026.
Copies of the press release and presentation are filed as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K (the “Report”) and are incorporated by reference.
The information contained in the presentation is summary information that is intended to be considered in the context of the more complete information included in the Company’s filings with the Securities and Exchange Commission (“SEC”) and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in the presentation in this Report, although it may do so from time to time as its management believes is appropriate. Any such update may be made through the filing of other reports or documents with the SEC.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding Alumis’ plans to submit an NDA in the second half of 2026, the potential for envudeucitinib to transform the treatment landscape for IL-23/IL-17-driven diseases as well as those driven by Type I interferon, the potential for envudeucitinib to meaningfully elevate care for and effectively reduce the full burden of disease for patients with moderate-to-severe plaque psoriasis, the expected availability of one-year Phase 3 long-term data in the second half of 2026, the development of a once-daily formulation and a pediatric development plan for envudeucitinib, the ongoing nature of the ONWARD clinical program, the timing of Alumis’ topline readout in its LUMUS Phase 2b program and statements regarding Alumis’ future plans and prospects, including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this Report are based on Alumis’ current expectations, estimates and projections only as of the date of this Report and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to whether regulatory authorities determine that envudeucitinib in moderate-to-severe plaque psoriasis is sufficiently safe and efficacious and grant regulatory approval; whether regulatory authorities accept for filing Alumis’ planned NDA submission; Alumis’ ability to obtain regulatory approval of and ultimately commercialize Alumis’ clinical candidates, the timing and results of preclinical and clinical trials, Alumis’ ability to fund development activities and achieve development goals, and Alumis’ ability to protect its intellectual property. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Alumis’ filings and reports with the SEC under the heading “Risk Factors” and elsewhere in such filings and reports, including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit No. |
Description | |
| 99.1 | Press Release, dated March 28, 2026. | |
| 99.2 | Late-Breaker Presentation, dated March 28, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Alumis Inc. | ||
| By: | /s/ Martin Babler | |
| Martin Babler | ||
| President & Chief Executive Officer | ||
Dated: March 30, 2026
Exhibit 99.1
Alumis’ Envudeucitinib Delivers Early and Robust Improvements in Skin Clearance, Quality of Life and Psoriasis Symptoms in Two Phase 3 Trials, Underscoring Its Potential as a Leading Oral Therapy for Plaque Psoriasis
- Envudeucitinib achieved robust PASI responses by Week 16, with significant continued improvements by Week 24 in PASI 90 (68.0%, 62.1%) and PASI 100 (41.0%, 39.5%)
- Quality-of-life improvements and itch relief emerged ahead of PASI 90 skin clearance, and clear or almost clear scalp psoriasis emerged by Week 4, highlighting envudeucitinib’s early onset and broad clinical benefit
- Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program
- Results presented as a late-breaking oral presentation at the 2026 American Academy of Dermatology (AAD) Annual Meeting
- Conference call and webcast scheduled for March 29, 2026, at 5:00 pm MDT / 7:00 pm EDT
SOUTH SAN FRANCISCO, Calif., March 28, 2026 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced new data from its Phase 3 ONWARD1 and ONWARD2 clinical trials evaluating envudeucitinib, a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor for moderate-to-severe plaque psoriasis. The data were presented in a late-breaking oral session at the 2026 AAD Annual Meeting.
Envudeucitinib demonstrated robust skin clearance, achieving high thresholds of clinical response at Week 16 that continued to deepen through Week 24 in both trials. Psoriasis Area and Severity Index (PASI) 90 responses, which emerged as early as Week 4, were achieved by 59.9% and 53.1% of envudeucitinib patients at Week 16 (and by 4.8% and 4.3% of placebo patients), increasing to 68.0% and 62.1% at Week 24. PASI 100 responses followed a similar trajectory, with 29.4% and 27.7% of envudeucitinib patients achieving complete skin clearance at Week 16 (as compared to 0.9% and 0.9% of placebo patients), rising to 41.0% and 39.5% at Week 24.
Envudeucitinib also demonstrated improvements in scalp psoriasis, a high-impact, difficult-to-treat area marked by profound effects on quality of life. At Week 24, approximately three out of four envudeucitinib patients1 achieved clear or almost clear scalp psoriasis, measured by the Scalp Specific Physician’s Global Assessment (ss-PGA 0/1), with over 30% responding as early as Week 4.
1 Based on patients with baseline ss-PGA ≥3
Broad and meaningful clinical benefits emerged early. Notably, quality-of-life and itch improvements appeared before PASI 90 skin clearance responses and continued to deepen through Week 24 across both trials.
| · | By Week 12, approximately 50% of envudeucitinib patients2 achieved Dermatology Life Quality Index (DLQI) 0/1, demonstrating minimal to no impact of disease on quality of life. |
| · | By Week 16, envudeucitinib patients achieved an average improvement of more than 4 points from baseline on the 0–10 Worst Pruritus Numeric Rating Scale (NRS), with clinically meaningful itch relief as early as Week 2—one of the most burdensome symptoms of psoriasis. |
“What stands out with envudeucitinib in these trials is how quickly patients begin to feel relief from symptoms, and how deeply those improvements continue to build,” said leading dermatologist and psoriasis expert Dr. Andrew Blauvelt. “For people living with the daily burden of plaque psoriasis, this degree of skin clearance and symptom improvement from an oral investigational drug is impressive, especially when high-impact sites are involved.”
Treatment with envudeucitinib was generally well tolerated through Week 24 in both trials, with a safety profile consistent with the Phase 2 program, including its long-term extension study. No clinically significant laboratory abnormalities or cases of tuberculosis reactivation were observed. Treatment-emergent adverse events were mostly mild, transient, self-limited, or responding to standard therapy, with the most common being headache, nasopharyngitis, upper respiratory tract infection, and acne. No new safety signals were observed.
“Envudeucitinib delivered the level of skin clearance, symptom relief, and safety in Phase 3 that the TYK2 mechanism has long promised but that has not been fully realized—until now—with sustained, maximal 24-hour inhibition of the IL-23 / IL-17 pathways,” said Dr. Jörn Drappa, Chief Medical Officer of Alumis. “The depth of clinical response, together with the favorable safety profile observed, underscores a differentiated clinical profile among marketed and investigational oral options and supports envudeucitinib’s potential to play a leading role in the treatment of patients with moderate-to-severe plaque psoriasis.”
Alumis is continuing to evaluate the long-term efficacy and safety of envudeucitinib in the ONWARD3 long-term extension trial and plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of this year.
Conference Call, Presentation and Webcast Details
Alumis will host a webcast for the investment community to review the Phase 3 ONWARD results presented at AAD which will begin at 5:00 pm MDT / 7:00 pm EDT on Sunday, March 29, 2026. The live webcast can be accessed via this link or on the Events tab on the Investors section of the Company’s website. A replay of the webcast will be made available on the Company’s website following the call. In addition, Alumis has posted the AAD presentation under the Publications section of the Company's website.
2 Based on patients with baseline DLQI ≥2
About the Phase 3 ONWARD Clinical Program
The Phase 3 ONWARD clinical program includes two parallel global, multicenter, randomized, double-blind, placebo and active-comparator-controlled 24week trials—ONWARD1 (NCT06586112) and ONWARD2 (NCT06588738)—evaluating the efficacy and safety of envudeucitinib in adults with moderate-to-severe plaque psoriasis. More than 1,700 patients were enrolled and randomized 2:1:1 to receive envudeucitinib 40 mg twice daily, placebo, or apremilast. Co-primary endpoints at Week 16 were the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0/1 compared with placebo. Patients completing Week 24 were eligible to enter ONWARD3 (NCT06846541), an ongoing long-term extension study assessing durability, greater maintenance of response, and long-term safety. The ONWARD clinical trials did not have a fasting requirement.
About Envudeucitinib
Envudeucitinib is a next-generation, highly selective, oral allosteric inhibitor of tyrosine kinase 2 (TYK2) precision-engineered for maximal 24-hour TYK2 inhibition to correct immune dysregulation across a range of diseases driven by proinflammatory mediators, including IL-23, IL-17, and Type I interferon. It is the only TYK2 inhibitor shown to deliver maximal target inhibition over 24 hours in humans. Clinical data indicate its selective targeting delivered sustained, maximal 24-hour inhibition in patients with psoriasis while minimizing off-target binding and effects. Alumis is currently evaluating the long-term efficacy and safety of envudeucitinib in the Phase 3 ONWARD3 clinical program for moderate-to-severe plaque psoriasis. Envudeucitinib is also being evaluated in LUMUS, a potentially pivotal Phase 2b clinical trial in patients with systemic lupus erythematosus, with topline data expected in the third quarter of 2026.
About Plaque Psoriasis
Plaque psoriasis is a chronic, immune-mediated disease driven by dysregulated IL-23 and IL-17 pathways that cause painful, itchy, scaly patches. It affects more than 8 million adults in the U.S. and often involves high-impact areas such as the scalp, face, hands, feet, and nails, significantly disrupting daily life. According to the National Psoriasis Foundation, about one in four patients has moderate-to-severe disease, based on quality-of-life impact and body surface area involved. Many remain inadequately controlled on current oral and topical treatments, underscoring the need for more effective, safe, and durable oral options that address the full burden of disease.
About TYK2 in Immune-Mediated Disease
Tyrosine kinase 2 (TYK2) is a key immune-signaling enzyme that regulates pathways across innate and adaptive immunity, including the IL-23/IL-17 axis and Type I interferon signaling that drive many high-burden immune-mediated diseases. Selective TYK2 inhibition has been widely validated as an effective, safe, and well-tolerated therapeutic approach. Genomic analyses conducted by Alumis highlight TYK2’s broad therapeutic potential, showing that it contributes to the pathogenesis of roughly 20 immune-driven conditions—including psoriasis, lupus, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. Additional evidence supports a genetic rationale for TYK2 inhibition in neuroinflammatory and neurodegenerative diseases where targeting TYK2 may offer a novel approach to treatment.
About Alumis
Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of envudeucitinib for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit www.alumis.com or follow us on LinkedIn or X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding Alumis’ plans to submit an NDA in the second half of 2026, the potential for envudeucitinib to play a leading role in the treatment of patients with moderate-to-severe plaque psoriasis, the timing of Alumis’ topline readout in its LUMUS Phase 2b program and statements regarding Alumis’ future plans and prospects, including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis’ current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to whether regulatory authorities determine that envudeucitinib in moderate-to-severe plaque psoriasis is sufficiently safe and efficacious and grant regulatory approval; whether regulatory authorities accept for filing Alumis’ planned NDA submission; Alumis’ ability to obtain regulatory approval of and ultimately commercialize Alumis’ clinical candidates, the timing and results of preclinical and clinical trials, Alumis’ ability to fund development activities and achieve development goals, and Alumis’ ability to protect its intellectual property. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Alumis’ filings and reports with the Securities and Exchange Commission (SEC) under the heading “Risk Factors” and elsewhere in such filings and reports, including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Alumis Contact Information
Teri Dahlman
Red House Communications
teri@redhousecomms.com
| 1 Envudeucitinib (ESK-001) in Moderate-to-Severe Plaque Psoriasis: 24-Week Results From the Randomized, Double-Blind, Active Comparator- and Placebo-Controlled, Phase 3 ONWARD 1 and 2 Studies Andrew Blauvelt1, Howard Sofen2, April Armstrong3, Benjamin Ehst4-6 , Jennifer Soung7, Maryam Shayesteh Alam8, David Rodriguez9, Jolanta Weglowska10 , Domenico Vitarella11, Grace Ma11, Elisa Muscianisi11 1Blauvelt Consulting, LLC, Annapolis, MD, USA; 2Department of Medicine/Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 3Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 4Oregon Medical Research Center, Portland, OR, USA; 5Broadway Medical Clinic, Portland OR, USA; 6Oregon Health & Science University, Portland, OR, USA; 7Southern California Dermatology Inc., Santa Ana, CA, USA; 8SimcoDerm Medical and Surgical Dermatology Centre, Barrie, ON, Canada; 9International Dermatology Research, Inc., Miami, FL, USA; 10Department of Dermatology, Research and Development Center, Regional Specialist Hospital, Wrocław, Poland; 11Alumis Inc., South San Francisco, CA, USA. Exhibit 99.2 |
| 2 Disclosures 〉 Presenting author: AB has served as a speaker for and received honoraria from Almirall, Eli Lilly, LEO Pharma, Sanofi, and UCB; has served as a scientific adviser for and received honoraria from AbbVie, Almirall, Alumis Inc., Amgen, AnaptysBio, Apogee Therapeutics, Arcutis Biotherapeutics, Eli Lilly, Incyte, Janssen, LEO Pharma, Novartis, Oruka Therapeutics, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sun Pharma, Takeda, and UCB; and owns stock in Lipidio Pharma and Oruka Therapeutics 〉 Coauthors (relevant to study): HS has nothing to report. AA has served as a research investigator, scientific adviser, or speaker for Alumis Inc. BE has received fees/honoraria/royalties as an advisory board member, contributor, and/or consultant for Alumis Inc., and received institutional funding as an investigator for Alumis Inc. JS has served as an investigator for Alumis Inc. MSA and DR have nothing relevant to disclose. JW has served as an investigator for Alumis Inc. DV, GM, and EM are employees and shareholders of Alumis Inc. 〉 All authors met the ICMJE authorship criteria and had full access to relevant data 〉 The ONWARD program is currently ongoing, and these studies were sponsored by Alumis Inc. 〉 Envudeucitinib is an investigational therapy not reviewed or approved by any regulatory agency ICMJE, International Committee of Medical Journal Editors. |
| Envudeucitinib is an investigational therapy not reviewed or approved by any regulatory agency. IL-12/17/23, interleukin 12/17/23; IFN-I, interferon type I; JH1/2, Janus kinase homology 1/2; TYK2, tyrosine kinase 2; TYK2i, TYK2 inhibitor. 1. Ucpinar S, et al. Clin Transl Sci. 2024;17(12):e70094. 2. Blauvelt A, et al. J Am Acad Dermatol. 2026;94(1):57-65. 3. Papp KA, et al. J Am Acad Dermatol. 2026;94(1):187-95. 3 Envudeucitinib: A Next-Generation TYK2i for Moderate-to-Severe Psoriasis 〉 Envudeucitinib, a next-generation, oral, allosteric TYK2i, provides maximal inhibition over a 24-hour period in patients with psoriasis1,2 〉 STRIDE Phase 2 and its open-label extension results demonstrated the favorable benefit/risk profile of envudeucitinib, with meaningful clinical efficacy throughout 52 weeks, and good tolerability2,3 Envudeucitinib TYK2 ATP JH2 domain Regulatory binding site JH1 domain Catalytic active site IL-12, IL-23, IFN-I IL-23/IL-17, IL-12, and IFN-I pathways blocked Reduced circulating cytokines driving psoriasis |
| 4 ONWARD1 and ONWARD2: Study Designs and Endpoints aReplicate design; actual enrollment is reported as ONWARD1 (NCT06586112); ONWARD2 (NCT06588738). BID, bis in die (twice daily); BSA, body surface area; BSL, baseline; DLQI-0/1, Dermatology Life Quality Index 0 or 1; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; PASI 75/90/100, ≥75%/≥90%/100% improvement in PASI; PGA, Physician’s Global Assessment; sPGA, static PGA; sPGA-0/1, sPGA 0 (clear) or 1 (almost clear); ss-PGA-0/1, scalp-specific PGA 0 (clear) or 1 (almost clear); W, week. BSL W24 (End of Treatment) W16 (Coprimary Endpoint) Placebo (n = 230; 211) Envudeucitinib 40 mg BID (n = 459; 433) 2:1:1 Randomization Apremilast 30 mg BID (n = 223; 215) Rollover to ONWARD3 OR Study Completion (W28 Safety Follow-up) W16 (Transition to Envudeucitinib) W2 W4 W8 W12 W20 ONWARD1 and ONWARD2a W1 Coprimary Endpoints (vs Placebo) 〉 PASI 75 〉 sPGA-0/1 Key Secondary Endpoints (vs Placebo or Apremilast) 〉 PASI 75/90/100 〉 sPGA-0/1 〉 Change from baseline in itch (NRS) 〉 ss-PGA-0/1 (baseline ≥3) 〉 DLQI-0/1 (baseline ≥2) Safety Endpoints Key Inclusion Criteria 〉 Age ≥18 years; weight >40 kg 〉 Plaque psoriasis ≥6 months 〉 BSA ≥10%; PASI ≥12; sPGA ≥3 〉 Phototherapy- or systemic therapy-eligible Key Exclusion Criteria 〉 Nonplaque psoriasis or other inflammatory skin conditions 〉 Immune-mediated conditions commonly associated with psoriasis |
| 5 Baseline Demographics and Disease Characteristics Were Balanced Across Arms and Representative of a Typical Moderate-to-Severe Population aIncludes Black or African American, Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native, and Other or not reported. bAny prior exposure to systemic therapies for psoriasis (excluded phototherapy); all patients were required to meet protocol-defined exclusion and washout criteria prior to Study Day 1. BID, bis in die (twice daily); BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; SD, standard deviation; sPGA, static Physician’s Global Assessment. ONWARD1 ONWARD2 Envudeucitinib 40 mg BID n = 459 Placebo n = 230 Apremilast 30 mg BID n = 223 Envudeucitinib 40 mg BID n = 433 Placebo n = 211 Apremilast 30 mg BID n = 215 Age, years, mean (SD) 49.1 (13.4) 49.2 (13.3) 47.7 (11.8) 48.3 (13.1) 49.5 (13.3) 48.0 (12.8) Age group, ≥65 years, n (%) 61 (13.3) 27 (11.7) 15 (6.7) 51 (11.8) 28 (13.3) 20 (9.3) Sex, male, n (%) 300 (65.4) 156 (67.8) 152 (68.2) 283 (65.4) 135 (64.0) 135 (62.8) Race, n (%) White 358 (78.0) 182 (79.1) 177 (79.4) 388 (89.6) 181 (85.8) 193 (89.8) Asian 68 (14.8) 28 (12.2) 30 (13.5) 10 (2.3) 10 (4.7) 7 (3.3) Othera 33 (7.2) 20 (8.7) 16 (7.2) 35 (8.1) 20 (9.5) 15 (7.0) Weight, kg, mean (SD) 90.4 (24.0) 91.0 (24.3) 88.9 (21.0) 92.3 (23.8) 91.1 (23.1) 90.8 (19.9) BMI, kg/m2, mean (SD) 30.6 (7.2) 30.6 (7.2) 29.8 (6.5) 31.2 (7.8) 31.1 (7.3) 30.9 (5.9) Duration of disease, years, mean (SD) 19.9 (13.5) 19.5 (13.3) 17.2 (11.8) 19.0 (13.5) 20.2 (14.5) 18.7 (14.5) PASI, mean (SD) 20.4 (8.0) 19.9 (7.5) 20.3 (6.9) 20.6 (8.3) 21.8 (9.0) 20.4 (8.4) sPGA of 4, n (%) 129 (28.1) 57 (24.8) 61 (27.4) 131 (30.3) 70 (33.2) 53 (24.7) BSA % affected, mean (SD) 25.8 (15.8) 26.2 (16.0) 25.2 (14.9) 25.2 (14.7) 27.3 (16.7) 25.8 (14.1) DLQI, mean (SD) 10.6 (6.5) 10.1 (6.7) 10.8 (6.8) 10.8 (7.0) 10.8 (6.8) 9.7 (7.1) Worst pruritus NRS, mean (SD) 6.1 (2.7) 6.0 (2.7) 6.3 (2.6) 6.4 (2.6) 6.4 (2.4) 6.0 (2.7) Prior systemic psoriasis treatment, n (%)b 221 (48.1) 113 (49.1) 107 (48.0) 213 (49.2) 105 (49.8) 102 (47.4) |
| 6 Robust and Statistically Significant PASI Response Rates at Week 16 Almost 30% of patients receiving envudeucitinib achieved PASI 100 at Week 16 ONWARD1 ONWARD2 Intention-to-treat population. The 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. aCoprimary endpoint: PASI 75 at Week 16 vs placebo. ***P <0.0001 vs placebo and apremilast. BID, bis in die (twice daily); CI, confidence interval; PASI, Psoriasis Area and Severity Index; PASI 75/90/100, ≥75%/≥90%/100% improvement in PASI. 6 ONWARD2 70.4 53.1 27.7 13.7 4.3 0.9 38.6 20.9 7.9 0 20 40 60 80 100 PASI 75 PASI 90 PASI 100 Responders, % (95% CI) Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215) Week 16 *** *** *** ONWARD1 Week 16 *** *** *** a a 76.5 59.9 29.4 18.7 4.8 0.9 44.4 21.5 4.0 0 20 40 60 80 100 PASI 75 PASI 90 PASI 100 Responders, % (95% CI) Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223) Coprimary Endpoint Coprimary Endpoint |
| 7 Approximately 65% and 40% of patients achieved PASI 90 and PASI 100 with envudeucitinib at Week 24 ONWARD2 Intention-to-treat population. The 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. aCoprimary endpoint: PASI 75 at Week 16 vs placebo. ***P <0.0001 vs placebo and apremilast. BID, bis in die (twice daily); CI, confidence interval; PASI, Psoriasis Area and Severity Index; PASI 75/90/100, ≥75%/≥90%/100% improvement in PASI. 70.4 53.1 27.7 13.7 4.3 0.9 38.6 20.9 7.9 0 20 40 60 80 100 PASI 75 PASI 90 PASI 100 Responders, % (95% CI) Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215) Week 16 Week 24 Sustained and Continued PASI Response Rates Through Week 24 *** *** *** *** *** *** ONWARD1 76.5 59.9 29.4 18.7 4.8 0.9 44.4 21.5 4.0 0 20 40 60 80 100 PASI 75 PASI 90 PASI 100 Responders, % (95% CI) Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223) Week 16 Week 24 *** *** *** *** *** 78.6 68.0 41.0 46.2 25.6 8.5 PASI 75 PASI 90 PASI 100 75.1 62.1 39.5 43.3 25.6 13.0 PASI 75 PASI 90 PASI 100 a a *** |
| 8 Envudeucitinib Resulted in Rapidly Increasing, Statistically Significant PASI 90 Response Rates vs Placebo and Apremilast Early onset of action: Separation vs placebo observed at Week 4 Intention-to-treat population. The 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. ***P <0.0001 vs placebo and apremilast. BID, bis in die (twice daily); CI, confidence interval; PASI 90, ≥90% improvement in Psoriasis Area and Severity Index. 0.0 4.8 27.4 45.2 59.9 66.7 68.0 0.5 0.4 2.6 4.4 4.8 18.8 39.0 0.5 2.7 7.6 15.9 21.5 22.5 25.6 0 20 40 60 80 100 0 4 8 12 16 20 24 PASI 90 Responders, % (95% CI) Week Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223) /Envudeucitinib 40 mg BID (n = 205) ONWARD1 ONWARD2 *** *** 0.5 4.4 24.8 44.2 53.1 56.6 62.1 0.0 0.0 0.9 2.9 4.3 18.1 39.5 0.5 1.4 10.7 16.4 20.9 25.9 25.6 0 20 40 60 80 100 0 4 8 12 16 20 24 PASI 90 Responders, % (95% CI) Week Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215) /Envudeucitinib 40 mg BID (n = 185) *** *** |
| 9 Envudeucitinib Demonstrated Robust and Progressive Improvement in PASI 100 Response Rates Over Time /Envudeucitinib 40 mg BID (n = 205) Approximately 40% complete skin clearance at Week 24 without evidence of plateau Intention-to-treat population. The 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. ***P <0.0001 vs placebo and apremilast. BID, bis in die (twice daily); CI, confidence interval; PASI 100, 100% improvement in Psoriasis Area and Severity Index. *** *** 0.2 0.7 9.3 21.2 27.7 34.7 39.5 0.0 0.0 0.5 1.0 0.9 6.0 18.4 0.0 0.0 2.3 5.2 7.9 11.3 13.0 0 20 40 60 80 0 4 8 12 16 20 24 PASI 100 Responders, % (95% CI) Week Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215) /Envudeucitinib 40 mg BID (n = 185) *** *** ONWARD1 ONWARD2 0.0 0.9 8.1 20.4 29.4 36.3 41.0 0.0 0.0 0.0 0.4 0.9 5.0 13.7 0.0 0.4 2.7 3.6 4.0 5.0 8.5 0 20 40 60 80 0 4 8 12 16 20 24 PASI 100 Responders, % (95% CI) Week Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223) |
| 10 Envudeucitinib Demonstrated Significant sPGA-0/1 and sPGA-0 Responses Approximately 60% and 30% of patients receiving envudeucitinib achieved sPGA-0/1 and sPGA-0 at Week 16, and responses continued to improve through Week 24 ONWARD1 ONWARD2 Intention-to-treat population. The 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. aCoprimary endpoint: sPGA-0/1 at Week 16 vs placebo. ***P <0.0001 vs placebo and apremilast. BID, bis in die (twice daily); CI, confidence interval; sPGA, static Physician’s Global Assessment; sPGA-0, sPGA 0 (clear); sPGA-0/1, sPGA 0 (clear) or 1 (almost clear). 61.0 69.3 10.0 46.3 26.5 27.4 0 20 40 60 80 100 0 4 8 12 16 20 24 sPGA-0/1, % (95% CI) Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223) 1.3 30.3 41.6 4.0 14.1 9.0 0 20 40 60 80 100 0 4 8 12 16 20 24 sPGA-0, % (95% CI) Week *** *** *** *** 57.3 63.5 5.7 44.9 27.4 32.1 0 20 40 60 80 100 0 4 8 12 16 20 24 sPGA-0/1, % (95% CI) Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215) 1.4 29.3 40.6 19.5 9.8 13.0 0 20 40 60 80 100 0 4 8 12 16 20 24 sPGA-0, % (95% CI) Week *** *** *** *** /Envudeucitinib 40 mg BID (n = 205) /Envudeucitinib 40 mg BID (n = 185) a a sPGA-0/1 sPGA-0/1 sPGA-0 sPGA-0 Coprimary Endpoint Coprimary Endpoint |
| 11 Patient with severe disease (PASI, 22.3; sPGA, 4) at baseline. PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. Week 0 Week 2 Week 8 Week 16 Visible Skin Improvement by Week 2 With Envudeucitinib |
| 12 Patient with moderate disease (PASI, 12.4; sPGA, 3) at baseline. PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. Week 0 Week 2 Week 8 Week 16 Envudeucitinib Resulted in Rapid and Significant Skin Improvement |
| 13 Patient with severe disease at baseline (PASI, 31.8; sPGA, 4) who crossed over from placebo to envudeucitinib at Week 16. PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. Week 0 Week 16 Week 24 Substantial Skin Improvement Achieved After Switching to Envudeucitinib in 8 Weeks Placebo Envudeucitinib |
| 14 Rapid, Significant, and Sustained Scalp Psoriasis Improvement With Envudeucitinib Approximately 3 in 4 patients receiving envudeucitinib achieved ss-PGA-0/1a at Week 24, with over 30% response as early as Week 4 Intention-to-treat population. The 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. aIn patients with baseline ss-PGA ≥3. ***P <0.0001 vs placebo at Week 16 and apremilast at Week 24. BID, bis in die (twice daily); CI, confidence interval; ss-PGA-0/1, scalp-specific Physician’s Global Assessment 0 (clear) or 1 (almost clear). 14.3 35.1 60.9 69.1 74.5 78.7 77.4 6.2 14.2 17.0 24.6 25.2 55.4 65.6 5.5 18.7 34.7 45.9 48.0 47.0 48.7 0 20 40 60 80 100 0 4 8 12 16 20 24 ss-PGA-0/1 Responders, % (95% CI) Week Envudeucitinib 40 mg BID (n = 274) Placebo (n = 135) Apremilast 30 mg BID (n = 150) /Envudeucitinib 40 mg BID (n = 122) 14.2 32.2 54.6 67.5 70.9 76.0 74.7 3.6 10.7 13.6 18.4 20.7 54.4 65.6 9.1 19.4 40.3 40.9 38.8 48.5 41.8 0 20 40 60 80 100 0 4 8 12 16 20 24 ss-PGA-0/1 Responders, % (95% CI) Week Envudeucitinib 40 mg BID (n = 285) Placebo (n = 140) Apremilast 30 mg BID (n = 134) ONWARD1 ONWARD2 /Envudeucitinib 40 mg BID (n = 125) *** *** *** *** |
| 15 Envudeucitinib Rapidly Reduced Itch With Deepening Response Over Time -2.0 -2.7 -3.5 -3.8 -4.1 -4.2 -4.3 -0.8 -0.6 -0.8 -1.0 -0.9 -3.0 -3.8 -1.3 -2.1 -2.5 -2.9 -2.7 -2.8 -2.7 -6 -5 -4 -3 -2 -1 0 0 4 8 12 16 20 24 Worst Pruritus NRS, Δ Baseline, LSM (95% CI) Week Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223) /Envudeucitinib 40 mg BID (n = 205) On average ˃4-point mean decrease from baseline in worst pruritus NRS by Week 12, with continued symptom improvement over time ONWARD1 ONWARD2 Intention-to-treat population. LSMs, CIs, and P-values are based on MMRM. ***P <0.0001 vs placebo and apremilast at Week 16. ††† P <0.0001 vs apremilast at Week 24 (nominal). BID, bis in die (twice daily); CI, confidence interval; LSM, least squares mean; MMRM, mixed model for repeated measures; NRS, numeric rating scale. -2.3 -3.2 -4.0 -4.5 -4.8 -4.9 -5.0 -0.8 -1.2 -1.4 -1.5 -1.6 -3.6 -4.3 -2.1 -2.8 -3.1 -3.3 -3.4 -3.6 -3.3 -6 -5 -4 -3 -2 -1 0 0 4 8 12 16 20 24 Worst Pruritus NRS, Δ Baseline, LSM (95% CI) Week Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215) /Envudeucitinib 40 mg BID (n = 185) *** *** ††† ††† |
| 16 Approximately 50% of patients receiving envudeucitinib reported DLQI-0/1a by Week 12, with continued improvement through Week 24 ONWARD1 ONWARD2 Intention-to-treat population. The 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. aIn patients with baseline DLQI ≥2. ***P <0.0001 vs placebo. ††† P <0.0001 vs apremilast (nominal). BID, bis in die (twice daily); CI, confidence interval; DLQI-0/1, Dermatology Life Quality Index 0 (no impact) or 1 (minimal impact). Envudeucitinib Treatment Significantly Improved Patient Quality of Life 11.4 27.1 39.6 51.7 57.5 63.4 63.7 11.3 15.6 13.3 15.2 12.3 30.8 48.9 11.4 17.9 23.2 32.2 36.2 32.5 31.9 0 20 40 60 80 100 0 4 8 12 16 20 24 DLQI-0/1 Responders, % (95% CI) Week Envudeucitinib 40 mg BID (n = 424) Placebo (n = 211) Apremilast 30 mg BID (n = 207) /Envudeucitinib 40 mg BID (n = 188) 11.1 22.9 41.2 49.9 56.0 58.7 60.1 5.3 11.2 7.7 11.6 10.7 35.7 47.7 16.1 20.5 32.5 34.2 35.9 40.1 40.0 0 20 40 60 80 100 0 4 8 12 16 20 24 DLQI-0/1 Responders, % (95% CI) Week Envudeucitinib 40 mg BID (n = 393) Placebo (n = 196) Apremilast 30 mg BID (n = 195) /Envudeucitinib 40 mg BID (n = 174) *** ††† *** ††† |
| 17 Benefits in Itch Reduction and Quality of Life Visible Before Skin Clearance Patients receiving envudeucitinib showed robust, early improvements in DLQI and itch that preceded PASI 90 responses ONWARD1 ONWARD2 Intention-to-treat population. For DLQI and PASI 90, the 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. For itch, LSMs, CIs, and P-values are based on MMRM. aLSM change from baseline in worst pruritus NRS. BID, bis in die (twice daily); CI, confidence interval; DLQI, Dermatology Life Quality Index; DLQI-0/1, DLQI 0 or 1; LSM, least-squares mean; MMRM, mixed model for repeated measures; NRS, numeric rating scale; PASI 90, ≥90% improvement in Psoriasis Area and Severity Index. Week 0 20 40 60 80 0 4 8 12 16 20 24 Responders, % (95% CI) Envudeucitinib 40 mg BID -8 -6 -4 -2 0 Itch Δ Baselinea (95% CI) DLQI-0/1 PASI 90 ITCH Week 0 20 40 60 80 0 4 8 12 16 20 24 Responders, % (95% CI) Envudeucitinib 40 mg BID -8 -6 -4 -2 0 Itch Δ Baselinea (95% CI) DLQI-0/1 PASI 90 ITCH |
| 18 ONWARD1 and ONWARD2 Pooled Safety Through Week 16 〉 Envudeucitinib showed low rates of SAEs and AEs leading to discontinuation, with no clusters of events – No deaths; no MACE or cytopenia signals; no TB reactivationb 〉 No clinically significant laboratory abnormalities were observed across lipid, hematologic, or chemistry panels, with comparable variability across treatment arms up to Week 16 Safety analysis population; pooled ONWARD1 and ONWARD2 data. aTEAEs occurring in ≥5% of patients in any treatment arm through either Week 16 or Week 24. bThirty-nine patients with latent or treated TB were enrolled. AE, adverse event; BID, bis in die (twice daily); MACE, major adverse cardiovascular event; SAE, serious AE; TB, tuberculosis; TEAE, treatment-emergent AE. Through Week 16 n (%) Envudeucitinib 40 mg BID n = 890 Placebo n = 441 Apremilast 30 mg BID n = 438 ≥1 TEAE 524 (58.9) 166 (37.6) 223 (50.9) ≥1 SAE 19 (2.1) 5 (1.1) 5 (1.1) TEAE leading to treatment discontinuation 30 (3.4) 7 (1.6) 9 (2.1) TEAE grade ≥3 42 (4.7) 14 (3.2) 18 (4.1) Most-frequent TEAEs (≥5%)a Nasopharyngitis 64 (7.2) 21 (4.8) 16 (3.7) Headache 92 (10.3) 11 (2.5) 40 (9.1) Upper respiratory tract infection 43 (4.8) 7 (1.6) 16 (3.7) Acne 53 (6.0) 3 (0.7) 3 (0.7) Nausea 20 (2.2) 4 (0.9) 23 (5.3) Diarrhea 14 (1.6) 11 (2.5) 36 (8.2) |
| 19 ONWARD1 and ONWARD2 Pooled Safety Through Weeks 16 and 24 Through Week 16 Through Week 24 n (%) Envudeucitinib 40 mg BID n = 890 Placebo n = 441 Apremilast 30 mg BID n = 438 Envudeucitinib 40 mg BID only n = 890 Placebo to Envudeucitinib 40 mg BID n = 390 Overall Envudeucitinib 40 mg BID n = 1280 Apremilast 30 mg BID n = 438 ≥1 TEAE 524 (58.9) 166 (37.6) 223 (50.9) 563 (63.3) 130 (33.3) 693 (54.1) 248 (56.6) ≥1 SAE 19 (2.1) 5 (1.1) 5 (1.1) 24 (2.7) 1 (0.3) 25 (2.0) 6 (1.4) TEAE leading to treatment discontinuation 30 (3.4) 7 (1.6) 9 (2.1) 31 (3.5) 4 (1.0) 35 (2.7) 12 (2.7) TEAE grade ≥3 42 (4.7) 14 (3.2) 18 (4.1) 48 (5.4) 7 (1.8) 55 (4.3) 23 (5.3) Most-frequent TEAEs (≥5%)a Nasopharyngitis 64 (7.2) 21 (4.8) 16 (3.7) 92 (10.3) 18 (4.6) 110 (8.6) 26 (5.9) Headache 92 (10.3) 11 (2.5) 40 (9.1) 97 (10.9) 11 (2.8) 108 (8.4) 42 (9.6) Upper respiratory tract infection 43 (4.8) 7 (1.6) 16 (3.7) 57 (6.4) 2 (0.5) 59 (4.6) 21 (4.8) Acne 53 (6.0) 3 (0.7) 3 (0.7) 60 (6.7) 17 (4.4) 77 (6.0) 3 (0.7) Nausea 20 (2.2) 4 (0.9) 23 (5.3) 20 (2.2) 0 20 (1.6) 23 (5.3) Diarrhea 14 (1.6) 11 (2.5) 36 (8.2) 16 (1.8) 1 (0.3) 17 (1.3) 36 (8.2) Safety analysis population; pooled ONWARD1 and ONWARD2 data. aTEAEs occurring in ≥5% of patients in any treatment arm through either Week 16 or Week 24. bThirty-nine patients with latent or treated TB were enrolled. AE, adverse event; BID, bis in die (twice daily); MACE, major adverse cardiovascular event; SAE, serious AE; TB, tuberculosis; TEAE, treatment-emergent AE. 〉 Envudeucitinib showed low rates of SAEs and AEs leading to discontinuation, with no clusters of events – No deaths; no MACE or cytopenia signals; no TB reactivationb 〉 No clinically significant laboratory abnormalities were observed across lipid, hematologic and chemistry panels, with comparable variability across treatment arms throughout the study 〉 At Week 24, low incidence of serious infections (0.7%) and malignancies (0.2%) observed in patients treated with envudeucitinib |
| 20 Envudeucitinib, a next-generation TYK2i, delivered early and progressively deepening skin clearance, with meaningful improvements in patient-reported outcomes in ONWARD1 and 2 〉All primary and secondary efficacy endpoints met, with approximately 65% and 40% of patients receiving envudeucitinib achieving PASI 90 and PASI 100 at Week 24 〉Rapid and significant improvement in moderate-to-severe scalp psoriasis, itch, and quality of life 〉Envudeucitinib treatment was generally well tolerated, with no new signals and a safety profile consistent with the previous long-term Phase 2 studies 〉One year, Phase 3 long-term data will be available in the second half of 2026 〉Once-daily formulation and pediatric plan under development Envudeucitinib is an investigational therapy not reviewed or approved by any regulatory agency. PASI 90/100, ≥90%/100% improvement in Psoriasis Area and Severity Index; TYK2i, tyrosine kinase 2 inhibitor. |
| 21 Acknowledgments 〉 The Authors thank the patients and their families for their participation and the study sites and teams for their facilitation of the ONWARD clinical studies 〉 The Authors thank Komal Bawa, PharmD, of Alumis Inc., for assistance with data publication and editorial review. Writing and editorial support were provided by Sylvia Stankov, PhD, of Red Nucleus, and were funded by Alumis Inc. |
