Innovent Announces Results of a Phase 2 Study of Picankibart (Anti-IL-23p19 Antibody) in Plaque Psoriasis, Showing Efficacy in Patients with Prior Inadequate Response to IL-17 Biologics
Rhea-AI Summary
Innovent Biologics announces promising Phase 2 study results for picankibart, an anti-IL-23p19 antibody, in treating plaque psoriasis patients who previously showed inadequate response to other biologics. The study, involving 152 patients, demonstrated that 64.6% (42/65) of patients with prior inadequate response to IL-17 biologics achieved skin clearance or near clearance after 16 weeks of treatment. The primary endpoint was met with 48.2% (40/83) of patients achieving both sPGA score of 0 or 1 and BSA 3%. The treatment showed a favorable safety profile with no new safety signals identified. This marks the first clinical study in China evaluating a switch from other biologics to an IL-23p19-targeted drug.
Positive
- 64.6% of patients achieved skin clearance or near clearance (sPGA 0 or 1)
- 48.2% of patients met the stringent primary endpoint criteria
- 18.1% of patients reached complete skin clearance (sPGA 0)
- 38% of qualifying patients achieved significant quality of life improvement (DLQI 0 or 1)
- NDA currently under review by NMPA
- Favorable safety profile with no new safety signals
Negative
- 51.8% of patients failed to meet the primary endpoint criteria
- Long disease course (median 12 years) indicates challenging patient population
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SAN FRANCISCO and SUZHOU, China, Oct. 28, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces the latest clinical results of a multicenter, open-label Phase 2 study (ClinicalTrials.gov, NCT05970978) of picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, in patients with plaque psoriasis previously responded inadequately to other biologics. Robust efficacy and favorable safety profile were observed.
Biologics have become the mainstream systemic treatment for psoriasis; however, a considerable proportion of patients do not respond to initial biologic agents. This is the first clinical study in China evaluating a switch from other biologics to an IL-23p19-targeted drug. The study demonstrated that after 16-week of treatment with picankibart, the majority of patients (
The first clinical trial in China for switching from other biologics to an IL-23p19 antibody in the field of psoriasis
This study aims to evaluate the efficacy and safety in patients with plaque psoriasis who switched from other biologics to picankibart. A total of 152 patients, previously treated with marketed biologics for plaque psoriasis—including IL-17 inhibitors and TNF-α inhibitors—were enrolled. Patients with prior inadequate response at baseline (defined as a static Physician's Global Assessment [sPGA] score of ≥2, or body surface area [BSA] of ≥
Patients at baseline had a long disease course with inadequate response to previous IL-17 inhibitors
Of the 152 enrolled patients in the study, 83 (
The primary endpoint was met with rapid onset of efficacy. The efficacy in clearing lesions for patients with inadequate response suggests best-in-class performance
- Nearly half (
48.2% , 40/83) of patients with prior inadequate response at baseline met the primary endpoint, achieving an sPGA of 0 or 1 and BSA of <3% ; - For secondary endpoints, of the 65 patients with baseline sPGA of ≥2 and BSA of ≥
3% , the majority (64.6% ,42/65) achieved sPGA of 0 or 1, and 15 patients (18.1% ) reached sPGA of 0; - Of the 71 patients with baseline sPGA of ≥2 or BSA of ≥
3% and a baseline Dermatology Life Quality Index (DLQI) of >1, 27 (38.0% ) achieved DLQI of 0 or 1.
Favorable safety profile observed；long-term follow-up is ongoing
- The safety profile, which was comparable to other studies, was favorable with no new safety signals identified;
- The efficacy of picankibart in responders at baseline is still under follow-up, and full data of long-term efficacy and safety are expected to be published at future academic congresses or in peer-reviewed journals.
Professor Furen Zhang, the Principal Investigator of the Clinical Study, Dermatology Hospital Affiliated to Shandong First Medical University, stated, "Psoriasis is a chronic condition that significantly affects patients' physical and mental well-being and quality of life. Biologics have become the primary systemic treatment for moderate-to-severe, refractory, and special types of psoriasis. Despite their significant efficacy, a considerable proportion of patients still experience inadequate response during biologic therapy, necessitating the development of alternative treatments. I am pleased to see that picankibart has demonstrated favorable efficacy and safety in psoriasis patients with an inadequate response to prior biologic treatments, suggesting that picankibart could be a potential switching option. I look forward to confirming picankibart's benefits in the upcoming Phase 3 study, which could help more psoriasis patients."
Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent, stated, "As the first IL-23p19 monoclonal antibody independently developed by a Chinese biopharma, picankibart succeeded in a pivotal registration Phase 3 study and is currently under review for a New Drug Application (NDA) by the NMPA. We have initiated the lifecycle management of picankibart, aiming to address unmet clinical needs in psoriasis treatment. The results of this Phase 2 study are very encouraging. With the widespread use of biological agents, the issue of inadequate response with these drugs has gradually become more prominent in clinical practice and urgently needs to be addressed. This study shows that picankibart offers substantial skin clearance benefits even for patients with a inadequate response to other biologics (primarily anti-IL-17 agents). We will actively advance the Phase 3 clinical study to enrich the clinical evidence for picankibart in biologics switching and offer more treatment options for patients with psoriasis as soon as possible."
About Psoriasis
Psoriasis is a chronic, recurrent, inflammatory and systemic disease included by genetic and environmental factors, affecting individuals of all ages and genders. It typically presents as scaly erythema or plaques, with non-infections, localized or widespread distribution. As a life-long noninfectious condition, psoriasis is notoriously difficult to treat. The disease can be categorized into psoriasis vulgaris (including guttate psoriasis and plaque psoriasis), pustular psoriasis, erythrodermic psoriasis and arthropathic psoriasis. Approximately
About Picankibart (IBI112)
Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors. Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases.
Currently, multiple clinical studies of Picankibart are underway, including:
- Phase 3 study conducted in patients with moderate to severe plaque psoriasis (CLEAR-1), which has reached the study endpoints in May 2024;
- Phase 3 study conducted in patients with moderate to severe plaque psoriasis with randomized withdrawal and re-treatment;
- Phase 2 study in patients with moderate to severe plaque psoriasis who were previously treated with biologics;
- Phase 2 study in patients with moderate to severe active ulcerative colitis;
In September 2024, the NMPA accepted the first NDA for picankibart for the treatment of moderate to severe plaque psoriasis.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).
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