Apogee Therapeutics Announces Results Up to 9 Months from Phase 1 Trial of APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases
Apogee Therapeutics (APGE) announced updated positive results from its Phase 1 trial of APG777, a novel anti-IL-13 antibody for atopic dermatitis treatment. The trial demonstrated a well-tolerated safety profile with doses up to 1,200mg, showing a half-life of approximately 75 days - three to five times longer than current treatments. Key findings include dose-proportional pharmacokinetics, near-complete inhibition of pSTAT6, and sustained TARC inhibition up to 9 months. The company expects to report Phase 2 proof-of-concept data in 2H 2025, with potential for maintenance dosing every 3-6 months compared to current biweekly or monthly treatments.
Apogee Therapeutics (APGE) ha annunciato risultati aggiornati positivi dal suo studio di Fase 1 su APG777, un nuovo anticorpo anti-IL-13 per il trattamento della dermatite atopica. Lo studio ha dimostrato un profilo di sicurezza ben tollerato con dosi fino a 1.200 mg, mostrando un'emivita di circa 75 giorni, tre-cinque volte più lunga rispetto ai trattamenti attuali. I risultati chiave includono farmacocinetica proporzionale alla dose, inibizione quasi completa di pSTAT6 e inibizione sostenuta di TARC fino a 9 mesi. L'azienda prevede di riportare dati di prova-concetto di Fase 2 nella seconda metà del 2025, con potenziale per dosaggio di mantenimento ogni 3-6 mesi rispetto ai trattamenti attuali bisettimanali o mensili.
Apogee Therapeutics (APGE) anunció resultados positivos actualizados de su ensayo de Fase 1 de APG777, un nuevo anticuerpo anti-IL-13 para el tratamiento de la dermatitis atópica. El ensayo demostró un perfil de seguridad bien tolerado con dosis de hasta 1.200 mg, mostrando una vida media de aproximadamente 75 días, de tres a cinco veces más larga que los tratamientos actuales. Los hallazgos clave incluyen farmacocinética proporcional a la dosis, inhibición casi completa de pSTAT6 e inhibición sostenida de TARC hasta 9 meses. La compañía espera reportar datos de prueba de concepto de Fase 2 en la segunda mitad de 2025, con potencial para dosis de mantenimiento cada 3-6 meses en comparación con los tratamientos actuales cada dos semanas o mensuales.
Apogee Therapeutics (APGE)는 아토피 피부염 치료를 위한 새로운 항-IL-13 항체 APG777의 1상 시험에서 업데이트된 긍정적인 결과를 발표했습니다. 이 시험은 최대 1,200mg의 용량으로 잘 견디는 안전성 프로파일을 보여주었으며, 약 75일의 반감기를 나타냈습니다. 이는 현재 치료법보다 3~5배 더 긴 것입니다. 주요 발견 사항으로는 용량 비례 약동학, pSTAT6의 거의 완전한 억제, 9개월까지 지속되는 TARC 억제가 포함됩니다. 이 회사는 2025년 하반기에 2상 개념 증명 데이터 발표를 예상하고 있으며, 현재의 격주 또는 월례 치료와 비교하여 3~6개월마다 유지 용량을 적용할 수 있는 가능성이 있습니다.
Apogee Therapeutics (APGE) a annoncé des résultats positifs mis à jour de son essai de Phase 1 sur APG777, un nouvel anticorps anti-IL-13 pour le traitement de la dermatite atopique. L'essai a démontré un profil de sécurité bien toléré avec des doses allant jusqu'à 1 200 mg, montrant une demi-vie d'environ 75 jours, soit trois à cinq fois plus longtemps que les traitements actuels. Les résultats clés incluent une pharmacocinétique proportionnelle à la dose, une inhibition presque complète de pSTAT6 et une inhibition durable de TARC jusqu'à 9 mois. L'entreprise prévoit de communiquer des données de preuve de concept de Phase 2 au second semestre 2025, avec un potentiel pour des doses d'entretien tous les 3 à 6 mois par rapport aux traitements actuels en bihebdomadaire ou mensuel.
Apogee Therapeutics (APGE) hat aktualisierte positive Ergebnisse aus seiner Phase-1-Studie zu APG777, einem neuartigen Anti-IL-13-Antikörper zur Behandlung der atopischen Dermatitis, bekannt gegeben. Die Studie zeigte ein gut verträgliches Sicherheitsprofil mit Dosen von bis zu 1.200 mg und einer Halbwertszeit von etwa 75 Tagen, was drei- bis fünfmal länger ist als bei den derzeitigen Behandlungen. Zu den wichtigsten Ergebnissen gehören dosisproportionale Pharmakokinetik, nahezu vollständige Hemmung von pSTAT6 und anhaltende TARC-Hemmung über einen Zeitraum von bis zu 9 Monaten. Das Unternehmen erwartet, in der zweiten Hälfte des Jahres 2025 Daten aus der Phase-2-Praxisstudie zu veröffentlichen, mit dem Potenzial für eine Erhaltungsdosis alle 3-6 Monate im Vergleich zu den aktuellen zweiwöchentlichen oder monatlichen Behandlungen.
- Extended half-life of 75 days, 3-5x longer than current treatments
- Well-tolerated safety profile up to 1,200mg doses
- Sustained biomarker inhibition for up to 9 months
- Potential for reduced dosing frequency (3-6 months vs. 2-4 weeks)
- Phase 2 trial results not expected until second half of 2025
Insights
The Phase 1 trial results for APG777 demonstrate highly promising pharmacokinetic and pharmacodynamic profiles that could revolutionize atopic dermatitis treatment. The 75-day half-life is particularly significant, being
The sustained TARC suppression and near-complete pSTAT6 inhibition for up to 9 months suggest robust and durable anti-inflammatory effects. The dose-proportional pharmacokinetics and favorable safety profile indicate a well-behaved drug with predictable exposure. These characteristics, combined with the extended half-life, position APG777 as a potential best-in-class IL-13 inhibitor.
This data strengthens APG777's competitive position in the $20+ billion atopic dermatitis market. The extended dosing interval could provide a significant commercial advantage over established competitors like Dupixent, which requires more frequent administration. The clean safety profile and strong biomarker data reduce development risk heading into Phase 2 trials.
While pivotal efficacy data isn't expected until 2H 2025, these results suggest APG777 could capture substantial market share if approved. The potential expansion into asthma and COPD markets represents additional upside. Investors should note that successful Phase 2 results could trigger significant value appreciation for this
Pharmacokinetic data up to 9 months continue to support potential best-in-class profile, including a half-life of approximately 75 days, approximately three to five times that of currently approved treatments for moderate-to-severe AD
Key biomarker data from single doses of APG777 show near complete inhibition of pSTAT6 and sustained TARC inhibition up to 9 months
Proof-of-concept data from the ongoing APG777 Phase 2 clinical trial in patients with moderate-to-severe atopic dermatitis are expected in 2H 2025
APG777 has the potential to demonstrate improved clinical responses from greater exposures in induction and maintenance dosing of every 3- or 6-months
SAN FRANCISCO and WALTHAM, Mass., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced updated positive results from its ongoing Phase 1 clinical trial of APG777, a novel half-life extended anti-IL-13 antibody for the treatment for atopic dermatitis and other inflammatory diseases, in healthy volunteers up to nine months. These data will be presented at the American College of Allergy, Asthma & Immunology’s (ACAAI) 2024 Annual Scientific Meeting, held in Boston from October 24-28, 2024.
Today’s results build on the Phase 1 positive interim data announced in March 2024. This updated dataset includes findings from the 40 enrolled participants across three single-ascending dose (SAD) cohorts, now with nine months of follow-up, and two multiple-ascending dose (MAD) cohorts, now with six months of follow-up. Findings demonstrated that APG777, in single doses up to 1,200mg or multiple doses of 300mg, showed a well-tolerated safety profile. Pharmacokinetic (PK) data was consistent with what was previously reported, including a half-life of approximately 75 days, dose proportional increases in Cmax and AUC, and low variability. APG777’s pharmacodynamic (PD) profile showed near complete inhibition of pSTAT6 and sustained TARC inhibition up to 9 months. These findings further support Apogee’s ongoing Phase 2 clinical trial of APG777 in patients with moderate-to-severe AD, with the potential for improved clinical responses from greater exposures in induction and significantly less frequent dosing in maintenance at every three or six months compared to every two-to-four week dosing with currently approved biologic therapies. The company expects to report 16-week topline data from Part A of the trial in the second half of 2025.
“Results from our Phase 1 trial of APG777 continue to support a potential best-in-class PK and PD profile of APG777, in particular a near-complete inhibition of pSTAT6 and sustained TARC inhibition out to nine months following a single dose,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “Furthermore, we are pleased to see that APG777 continues to be well tolerated, and with APG777’s PK profile, we remain confident that we can achieve maintenance dosing of every 3- to 6- months in patients with moderate-to-severe AD. We are on track to report initial data from Part A of our Phase 2 clinical trial in patients with moderate to severe AD in the second half of next year. We look forward to sharing more on APG777 and providing an update on our progress across all programs as well as highlighting our combination strategy in further detail at our R&D Day on December 2nd.”
Key Findings from the Phase 1 APG777 Results Up to 9 Months:
- Dose proportional PK was observed, with a half-life of ~75 days, approximately three to five times that of currently approved treatments for moderate-to-severe AD consistent with previously reported interim results.
- APG777 demonstrated dose proportional increases in Cmax and AUC from 300mg up to 1,200mg across all SAD and MAD cohorts.
- Single and multiple doses of APG777 resulted in rapid and sustained effect on PD markers for up to nine months.
- Single doses of APG777 showed rapid, near-complete inhibition of pSTAT6, one of the first downstream markers of IL-13 pathway inhibition, up to nine months (limit of available follow up in SAD cohort);
- MAD cohorts showed similar inhibition of pSTAT6 through available follow-up. Single doses of APG777 suppressed TARC, an inflammatory mediator and the most strongly correlated biomarker to AD severity, with deep and sustained inhibition for up to nine months.
- APG777 was generally well-tolerated at doses up to 1,200 mg.
- Treatment-emergent adverse events were generally mild-to-moderate and unrelated to APG777.
- There were no serious adverse events or dose-dependent trends observed up to time of data cut.
Apogee’s poster presentation from ACAAI can be found on the Publications page of the company website.
About APG777
APG777 is a novel, subcutaneous extended half-life monoclonal antibody targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. In our head-to-head preclinical studies, APG777 demonstrated equivalent or better potency to lebrikizumab in the inhibition of IL-13 signaling. Based on its potentially best-in-class PK profile, APG777 has the potential for improved clinical responses from greater exposures of drug in induction and dosing as infrequently as once every three or six months. AD is a chronic inflammatory skin disorder which can lead to sleep disturbance, psychological distress, elevated infection risk and chronic pain, all of which significantly impact quality of life. Today’s treatments are associated with many challenges, including frequent injection regimens that can lead to poor patient compliance. APG777 represents the first clinical-stage product candidate from the company’s strategic collaboration with Paragon Therapeutics, Inc., an innovative discovery engine for biologics.
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com.
Forward Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s plans for its current and future product candidates and programs, particularly APG777; its plans for current and future clinical trials; expected timing for release of data from Apogee’s Phase 2 clinical trial of APG777 in AD; the potential clinical benefit, dosing schedule and half-life of APG777; plans for Apogee’s other product candidates, and any other potential programs, including combination therapies. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 5, 2024, Quarterly Report on 10-Q for the quarterly period ended June 30, 2024, filed with the SEC on August 12, 2024, and subsequent disclosure documents we may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics, Inc.
Noel.Kurdi@apogeetherapeutics.com
Media Contact:
Dan Budwick
1AB Media
dan@1abmedia.com
FAQ
What are the key results from Apogee Therapeutics (APGE) Phase 1 trial of APG777?
When will Apogee Therapeutics (APGE) report Phase 2 results for APG777?
How does APG777's dosing frequency compare to current atopic dermatitis treatments?
