Innovent's Picankibart (IBI112) Achieves Phase 3 Clinical Success in Moderate to Severe Plaque Psoriasis

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Innovent announced today that its drug picankibart (IBI112) achieved primary endpoints in a phase 3 clinical trial for moderate to severe plaque psoriasis. With these positive outcomes as support, Innovent plans to submit a New Drug Application (NDA) to China's Center for Drug Evaluation of the National Medical Product Administration.¹

Data for picankibart, a recombinant antibody targeting the interleukin 23p19 subunit (IL-23p19), stems from Innovent's CLEAR-1 study (NCT05645627), aimed at evaluating its success in Chinese patients with moderate to severe plaque psoriasis.²

The CLEAR-1 trial, the first global phase 3 study for the IL-23p19 class, enrolled 500 participants who were randomly assigned to receive either a placebo or picankibart. The treatment involved administering 200 mg of picankibart every 4 weeks for the first 12 weeks, followed by a maintenance dose of either 200 mg or 100 mg every 12 weeks.

The primary measures of success were the percentage of patients achieving at least a 90% improvement in their Psoriasis Area and Severity Index (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 showed a significantly higher efficacy of picankibart compared to the placebo, with 80.3% of treated subjects achieving PASI 90 and 93.5% reaching an sPGA score of 0 or 1, compared to 2.0% and 13.1% respectively for the placebo group. The study also demonstrated sustained results, with 84.9% of patients on the 200 mg dose maintaining PASI 90 and 85.9% maintaining an sPGA score of 0 or 1 at week 52.

Key secondary endpoints were also achieved, showing improvements across several metrics. A significant number of subjects reached at least a 75% improvement in PASI score (PASI 75), complete clearance of psoriasis (PASI 100), a clear sPGA score, and a Dermatology Life Quality Index score of 0 or 1 by week 16. These benefits persisted through the 52-week period.

Safety data from the trial indicated a favorable profile for picankibart, with no new safety concerns emerging.

"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," said Yulin Shi, a professor and the study's principal investigator, in a news release.¹

"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," Shi said. "I wish its successful application for marketing, which will provide a differentiated treatment option for Chinese patients with psoriasis."

References

1. Innovent announces picankibart (IBI112) achieved primary endpoints in a phase 3 clinical trial in treating moderate to severe plaque psoriasis, and plans to submit NDA to the NMPA. News release. Innovent. May 28, 2024. Accessed May 28, 2024. https://www.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=450
2. A study to evaluate IBI112 in the treatment of psoriasis with moderate to severe plaque psoriasis. ClinicalTrials.gov: NCT05645627. Last updated April 13, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05645627