Innovent Reports Phase 2 Results for Picankibart in Plaque Psoriasis Showing Efficacy in IL-17 Biologic Non-Responders

Innovent Biologics, Inc. (HKEX: 01801), a leading biopharmaceutical company based in San Francisco and Suzhou, China, has announced promising results from a Phase 2 clinical trial of picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection. The study focused on patients with plaque psoriasis who had previously shown inadequate responses to other biologic treatments. The trial, listed in ClinicalTrials.gov as NCT05970978, demonstrated strong efficacy and a favorable safety profile.

Psoriasis is a chronic inflammatory skin condition that significantly impacts patients' quality of life. Traditional biologics are the primary systemic treatments for severe cases, but many patients do not respond adequately to initial biologic therapies. Innovent's study is the first in China to evaluate the switch from other biologics to an IL-23p19-targeted drug such as picankibart. Over the 16-week treatment period, 64.6% of patients achieved significant skin clearance or near-clearance, suggesting that picankibart could be a valuable new option for patients with moderate to severe psoriasis.

The trial enrolled 152 patients previously treated with biologics for plaque psoriasis, including IL-17 and TNF-α inhibitors. Those with inadequate responses at baseline (sPGA score of ≥2 or body surface area [BSA] of ≥3%) received 200 mg of picankibart subcutaneously at weeks 0, 4, and 8, followed by maintenance doses every 12 weeks until week 32, with follow-up until week 44. Patients who responded well at baseline (sPGA score of 0 or 1 and BSA of <3%) received the same initial dose and then every 12 weeks until week 36, followed by a similar follow-up period.

A stringent primary endpoint was set: the proportion of patients reaching an sPGA score of 0 or 1 and BSA of <3% at week 16. This endpoint was more rigorous compared to other similar studies, which typically only measured sPGA scores. The results were impressive, with 48.2% of patients with inadequate responses at baseline meeting the primary endpoint. Additionally, 64.6% of these patients achieved an sPGA of 0 or 1, and 18.1% reached an sPGA of 0. Furthermore, 38.0% of patients with a baseline Dermatology Life Quality Index (DLQI) of >1 improved to a DLQI of 0 or 1, indicating significant quality of life improvements.

The safety profile of picankibart was favorable, comparable to other studies, with no new safety concerns identified. Long-term follow-up is ongoing, and comprehensive data on efficacy and safety is expected to be published in future academic venues.

Professor Furen Zhang, the Principal Investigator of the study from the Dermatology Hospital affiliated with Shandong First Medical University, emphasized the significance of these findings. He noted that despite the efficacy of current biologics, many patients still experience inadequate responses, necessitating the development of new treatments like picankibart. Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent, echoed this sentiment, highlighting the potential of picankibart to address unmet clinical needs in psoriasis treatment. He also revealed that picankibart is under review for a New Drug Application (NDA) by the NMPA, following the successful completion of a pivotal Phase 3 study.

Psoriasis affects millions worldwide and is particularly challenging to treat due to its chronic and systemic nature. Current treatments in China include methotrexate, cyclosporine A, retinoic acids, and biological agents, with IL-23 inhibitors becoming increasingly prominent due to their effectiveness and long-lasting results. The promising results from Innovent's Phase 2 study suggest that picankibart could offer a new and more effective treatment option for those struggling with inadequate responses to existing biologics.

Innovent Biologics, founded in 2011, continues to lead in the biopharmaceutical field with a focus on producing affordable, high-quality medicines. The company has already launched several products and has multiple new drugs under regulatory review. Innovent's commitment to innovation and patient care positions it as a key player in addressing some of the most challenging diseases today.