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 (64.6%,42/65) who had inadequate response to previous biologic agents (mainly those targeting IL-17), achieved skin clearance or near clearance with a sPGA of 0 or 1. Results from this study will provide evidence for novel long-term treatment regimens for patients with moderate to severe psoriasis. Innovent biologics will advance the Phase 3 clinical trial of picankibart.

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 ≥3%) received 200 mg of subcutaneously picankibart at weeks 0, 4, and 8 followed by dosing at every 12 weeks until week 32 and follow-up until week 44. Responders at baseline (sPGA score of 0 or 1 and BSA of <3%) received 200 mg of picankibart at week 0 and then every 12 weeks until week 36 and followed-up until week 44. The primary endpoint of the study was the proportion of patients achieving an sPGA score of 0 or 1 and BSA of < 3% at week 16. It is worthy to mention that our primary endpoint is more stringent than studies of other similar agents, which often used the proportion of patients achieving a sPGA of 0 or 1 as the primary endpoint.

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 (54.6%) were classified as inadequate responders, with a median disease course of 12 years. Among them, 80 (96.4%) had been treated with IL-17 inhibitors, 90.4% had a baseline sPGA ≥2 , and 86.7% had a baseline BSA ≥3%.

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."