Innovent Biologics, a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, 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 in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis. The rapid and significant efficacy demonstrate the best-in-class potential of picankibart on a global basis. 

High level of skin clearance was maintained through one year

The strong efficacy was maintained through week 52 in both groups of picankibart. The proportions of subjects achieving PASI 90 and sPGA 0/1 who received picankibart 200 mg every 12 weeks were 84.9% and 85.9%, respectively, at week 52. These results underpin the long-term robust efficacy of picankibart in treating moderate to severe psoriasis.

All key secondary endpoints were met, significantly improving patients' quality of life

In addition, all key secondary endpoints of the study were successfully met in both groups of picankibart, including the proportion of subjects achieving ≥ 75% improvement from baseline PASI score (PASI 75), the proportion of subjects achieving 100% improvement from baseline PASI score (PASI 100), the proportion of subjects achieving a sPGA score of clear (0), and the proportion of subjects with Dermatology Life Quality Index (DLQI) score of 0 or 1 at week 16. 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.

Professor Yulin Shi, the principal investigator of the clinical study, Shanghai Skin Disease Hospital, stated," Psoriasis is a lifelong disease, which has a great impact on the physical and mental health and quality of life of patients. Existing evidences show that IL-23p19 targeted antibodies have advantages in maintaining long-term efficacy and medication convenience. 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. I wish its successful application for marketing, which will provide a differentiated treatment option for Chinese patients with psoriasis."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, " Achievement of all primary and key secondary endpoints in CLEAR-1 has supported picankibart's outstanding efficacy and favorable safety as a new generation of IL-23p19 target drugs. Moreover, picankibart can be administered only 5-6 times per year, adding convenience value as a new treatment option compared to the current mainstream marketed drugs (7-16 times per year). At present, there is no IL-23p19 target drug independently developed by Chinese enterprises in the domestic market. We 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 plaque psoriasis. Meanwhile, we emphasis on product lifecycle management and will validate more clinical value of picankibart in multiple clinical studies and hope to fulfill unmet needs for patients that have developed drug-resistance or relapse."