Innovent's Picankibart (IBI112) Hits Phase 3 Targets for Plaque Psoriasis; NDA to NMPA Planned

Innovent Biologics, Inc. (Innovent), a prominent global biopharmaceutical company, recently announced a significant milestone with its drug picankibart (R & D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection. Picankibart has successfully met all primary and key secondary endpoints in the Phase 3 CLEAR-1 registrational study conducted among Chinese subjects suffering from moderate to severe plaque psoriasis.

CLEAR-1, the first global Phase 3 registration study in the IL-23p19 class, demonstrated that over 80% of subjects achieved a Psoriasis Area and Severity Index score (PASI 90) improvement after just 16 weeks of treatment. Innovent plans to submit a new drug application (NDA) to the Center for Drug Evaluation (CDE) of the National Medical Product Administration (NMPA) in China for picankibart's use in treating psoriasis.

The study, identified as NCT05645627, is a multicenter, randomized, double-blind, placebo-controlled trial. It enrolled a total of 500 participants who were randomized into different groups to receive either a placebo or picankibart. Picankibart was administered at a dose of 200 mg at weeks 0, 4, and 8, followed by either 200 mg or 100 mg every 12 weeks. The co-primary endpoints included the proportion of subjects achieving a 90% or greater improvement from baseline PASI score (PASI 90) and those achieving a static Physician’s Global Assessment (sPGA) score of clear (0) or almost clear (1) at the 16-week mark.

Results from the study were very encouraging, showing that 80.3% of subjects receiving picankibart achieved PASI 90, and 93.5% achieved sPGA 0 or 1, compared to 2.0% and 13.1% respectively in the placebo group. These results highlight the rapid and remarkable efficacy of picankibart, suggesting its potential to become a best-in-class treatment globally.

The high level of skin clearance achieved was sustained through one year, with 84.9% and 85.9% of subjects maintaining PASI 90 and sPGA 0/1, respectively, at week 52. This long-term efficacy underpins the drug’s robustness in treating moderate to severe psoriasis.

Additionally, all key secondary endpoints were met, with significant improvements in quality of life for patients. These secondary endpoints included the proportion of subjects achieving a 75% improvement from baseline PASI score (PASI 75), 100% improvement (PASI 100), a sPGA score of clear (0), and a Dermatology Life Quality Index (DLQI) score of 0 or 1 at week 16. The improvements were sustained through 52 weeks.

Picankibart also demonstrated a favorable safety profile, with no new safety signals detected, aligning with previous clinical trials. The study's follow-up continues, and complete data will be published in future academic forums.

Prof. Yulin Shi, the study’s principal investigator from Shanghai Skin Disease Hospital, emphasized the significant impact of psoriasis on patients' physical and mental health. He expressed optimism about picankibart, highlighting that it offers substantial short-term and long-term efficacy, improved convenience, and enhanced patient adherence due to its 12-week dosing schedule.

Dr. Lei Qian, Vice President of Clinical Development at Innovent, reinforced the drug's potential, noting that picankibart can be administered only 5-6 times per year, providing a more convenient option compared to the current treatments, which require more frequent dosing. Innovent is preparing to submit an NDA based on the CLEAR-1 results and is committed to exploring picankibart's clinical value in additional studies, aiming to address unmet needs for patients who have developed resistance or experienced relapse.

Innovent, established in 2011, focuses on developing high-quality biologics that are accessible and affordable. The company has a robust portfolio aimed at treating various diseases, including cancer, cardiovascular, metabolic, autoimmune, and eye diseases. Innovent collaborates with several global healthcare leaders to advance the biopharmaceutical industry and make innovative treatments widely available.