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
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.
Innovent Biologics annuncia risultati promettenti dello studio di fase 2 per picankibart, un anticorpo anti-IL-23p19, nel trattamento dei pazienti con psoriasi a placche che in precedenza hanno mostrato una risposta inadeguata ad altri biologici. Lo studio, che ha coinvolto 152 pazienti, ha dimostrato che il 64,6% (42/65) dei pazienti con precedente risposta inadeguata ai biologici anti-IL-17 ha ottenuto una clearance cutanea o quasi clearance dopo 16 settimane di trattamento. L'endpoint primario è stato raggiunto con il 48,2% (40/83) dei pazienti che hanno ottenuto sia un punteggio sPGA di 0 o 1 che una BSA <3%. Il trattamento ha mostrato un profilo di sicurezza favorevole, senza nuovi segnali di sicurezza identificati. Questo segna il primo studio clinico in Cina che valuta il passaggio da altri biologici a un farmaco mirato all'IL-23p19.
Innovent Biologics anuncia resultados prometedores del estudio de fase 2 para picankibart, un anticuerpo anti-IL-23p19, en el tratamiento de pacientes con psoriasis en placas que previamente mostraron una respuesta inadecuada a otros biológicos. El estudio, que involucró a 152 pacientes, mostró que el 64.6% (42/65) de los pacientes con respuesta inadecuada anterior a los biológicos anti-IL-17 logró una limpieza o casi limpieza de la piel tras 16 semanas de tratamiento. Se cumplió el objetivo primario, con un 48.2% (40/83) de los pacientes alcanzando tanto un puntaje de sPGA de 0 o 1 como un BSA <3%. El tratamiento mostró un perfil de seguridad favorable sin señales de seguridad nuevas identificadas. Este es el primer estudio clínico en China que evalúa un cambio de otros biológicos a un fármaco dirigido a IL-23p19.
Innovent Biologics는 picankibart의 2상 연구 결과가 유망하다고 발표했습니다. 이는 이전에 다른 바이오 의약품에 대한 반응이 불충분했던 판상 건선 환자를 치료하기 위한 항-IL-23p19 항체입니다. 152명의 환자가 참여한 이 연구는, IL-17 바이올 벤처에 대한 이전의 불충분한 반응을 보인 환자 중 64.6% (42/65)가 16주 치료 후 피부 맑음 또는 거의 맑음에 도달했음을 보여주었습니다. 주요 목표는 sPGA 점수가 0 또는 1이고 BSA <3%인 환자가 48.2% (40/83)에 도달하면서 충족되었습니다. 치료는 새로운 안전 신호가 확인되지 않은 유리한 안전 프로파일을 보였습니다. 이는 중국에서 다른 바이오 의약품에서 IL-23p19 표적 약물로의 전환을 평가한 첫 번째 임상 연구입니다.
Innovent Biologics annonce des résultats prometteurs d'une étude de phase 2 pour picankibart, un anticorps anti-IL-23p19, dans le traitement des patients atteints de psoriasis en plaques qui ont précédemment montré une réponse insatisfaisante à d'autres biologiques. L'étude, impliquant 152 patients, a montré que 64,6% (42/65) des patients ayant une réponse inadéquate antérieure aux biologiques anti-IL-17 ont obtenu une clairance cutanée ou une quasi-clarence après 16 semaines de traitement. L'objectif principal a été atteint, avec 48,2% (40/83) des patients atteignant un score sPGA de 0 ou 1 et un BSA <3%. Le traitement a présenté un profil de sécurité favorable, sans nouveaux signaux de sécurité identifiés. Il s'agit de la première étude clinique en Chine évaluant un passage d'autres biologiques à un médicament ciblant l'IL-23p19.
Innovent Biologics kündigt vielversprechende Ergebnisse der Phase-2-Studie zu picankibart, einem Anti-IL-23p19-Antikörper, zur Behandlung von Patienten mit plaque Psoriasis an, die zuvor unzureichend auf andere Biologika angesprochen hatten. Die Studie mit 152 Patienten zeigte, dass 64,6% (42/65) der Patienten mit zuvor unzureichendem Ansprechen auf IL-17-Biologika nach 16 Wochen Behandlung eine Hautklärung oder nahezu Hautklärung erreichten. Der primäre Endpunkt wurde erreicht, da 48,2% (40/83) der Patienten sowohl einen sPGA-Score von 0 oder 1 als auch eine BSA <3% erreichten. Die Behandlung zeigte ein günstiges Sicherheitsprofil, ohne neue Sicherheitsindikatoren zu identifizieren. Dies ist die erste klinische Studie in China, die den Wechsel von anderen Biologika zu einem IL-23p19-gerichteten Medikament bewertet.
- 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
- 51.8% of patients failed to meet the primary endpoint criteria
- Long disease course (median 12 years) indicates challenging patient population
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
The first clinical trial in
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.
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