Innovent Biologics, Inc. announced that picankibart (R & D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, has met all the primary endpoints and key secondary endpoints in the Phase 3 registrational study (CLEAR-1) in Chinese subjects with moderate to severe plaque psoriasis. CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients. Innovent plans to submit a new drug application (NDA) for picankibart in the treatment of psoriasis to the Center for Drug Evaluation (CDE) of National Medical Product Administration (NMPA).

Dosing interval set to 12 weeks. CLEAR-1 (NCT05645627) is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of picankibart in subjects with moderate to severe plaque Psoriasis. A total of 500 subjects were enrolled and randomized in a 1: 2: 2 ratio to receive placebo or picankibart 200 mg every 4 weeks at week 0, 4 and 8 followed by 200 mg or 100 mg every 12 weeks.

Co-primary endpoints were the proportion of subjects achieving 90% improvement from baseline Psoriasis Area and Severity Index score (PASI 90) and the proportion of subjects achieving a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16. The co-primary endpoints were successfully met, showing a rapid and significant efficacy of picankibart The study results showed that co-primary endpoints of CLEAR-1 were successfully met: at week 16, significantly higher proportion of subjects receiving picankibart achieved PASI 90 and sPGA 0 or 1 compared with placebo (80.3% vs. 2.0% for PASI 90 and 93.5% vs.

13.1% for sPGA 0/1, both p<0.0001). CLEAR-1 is global The first Phase 3 registration study inIL-23p19 class that reports over 80% of subjects achieve PASI 90 after 16 week of treatment in psoriasis. Picankibart showed superiority compared to placebo in improving all of these parameters and improvements maintained through 52 weeks.

Picankiabrt showed a favorable safety profile with no new safety signals. The overall safety profile of picankibart was favorable during the study, and no new safety signals were identified compared with previous clinical studies. Follow-up of the current study is ongoing and complete data will be published at future academic conferences or in peer-reviewed academic journals.

PASI is a lifelong disease, which has a great impact on the physical and mental health and quality of life of patients. As one of the investigators of picankibart, the first anti-IL-23p19 antibody independently developed by a domestic company, I am very excited to see that co-primary and all key secondary endpoints were met in CLEAR-1 study. These results demonstrate significant short-term onset and long-term maintenance of efficacy for picankibart; every-12-week administration also improves convenience and adherence, bringing patients with significant clinical benefits and quality of life improvements with favorable safety.

The company will actively prepare to submit the new drug application of picankibart based on the CLEAR-1 results, and strive to provide more convenient, friendly and effective treatment regimen for patients with moderate to severe plaqueiasis. Innovent has 10 products in the market, 4 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in the Phase III or pivotal clinical trials.