Innovent Biologics, Inc. (HKEX: 01801) has announced remarkable results from the CLEAR-1 Phase 3 registrational study of its novel drug, picankibart (R & D code: IBI112), signaling a major breakthrough in psoriasis treatment. The study demonstrated that picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, met all primary and key secondary endpoints, showcasing its potential as a high-efficacy treatment for moderate to severe plaque psoriasis.

Breakthrough Results in Phase 3 Study

The CLEAR-1 study, a multicenter, randomized, double-blind, placebo-controlled trial, is the first of its kind globally to report such promising results in the IL-23p19 class. Over 80% of the participants achieved a Psoriasis Area and Severity Index score improvement of 90% (PASI 90) after just 16 weeks of treatment, a testament to the drug’s rapid and significant efficacy. The study enrolled 500 subjects who were administered picankibart or placebo in a strategic dosing regimen, reinforcing picankibart’s potential as a best-in-class therapeutic agent on a global scale.

Maintained Efficacy and Safety Over One Year

Not only did picankibart demonstrate a high level of initial skin clearance, but it also maintained this efficacy through week 52. The continuation of results at this level underscores the long-term robustness of picankibart’s therapeutic benefits. Additionally, picankibart showed a favorable safety profile throughout the trial period, with no new safety signals emerging, which supports its use as a sustainable treatment option.

Enhancing Quality of Life for Patients

The study’s key secondary endpoints, which included improvements in PASI 75, PASI 100, and Dermatology Life Quality Index scores, were all met, significantly enhancing the quality of life for patients. This comprehensive success in various clinical measures points to picankibart’s superiority over placebos and its potential to set new standards in psoriasis treatment.

Professor Yulin Shi, the principal investigator from Shanghai Skin Disease Hospital, highlighted the drug’s potential impact on patients’ lives, citing its long-term efficacy and convenient dosing interval, which is expected to improve patient adherence and overall treatment experience. Dr. Lei Qian, Vice President of Clinical Development at Innovent, emphasized the strategic significance of these results, noting that picankibart could be administered fewer times per year compared to current treatments, enhancing convenience for patients.

In response to these positive outcomes, Innovent is preparing to submit a New Drug Application (NDA) for picankibart to the Center for Drug Evaluation (CDE) of the National Medical Product Administration (NMPA) in China.

Implications for the Biopharmaceutical Industry

Picankibart’s success in the CLEAR-1 study not only marks a significant milestone for Innovent Biologics but also for the biopharmaceutical industry in China. It represents a pioneering achievement in the development of targeted therapies by a domestic company in the competitive global biopharma market. This development is poised to influence future therapeutic strategies and regulatory approaches within the industry.

  autoimmune disease treatment, Biopharmaceutical Innovations, biotechnology, China drug development, CLEAR-1 study results, IL-23p19 antibody, Innovent Biologics, Phase 3 study, picankibart, psoriasis treatment