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

Rhea-AI Summary

Innovent Biologics announced that its recombinant antibody injection, picankibart (IBI112), has successfully met all primary and key secondary endpoints in the Phase 3 CLEAR-1 clinical trial for moderate to severe plaque psoriasis. Conducted across multiple centers with 500 participants, the study demonstrated that over 80% of subjects achieved a ≥90% improvement in their Psoriasis Area and Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of clear or almost clear (0 or 1) after 16 weeks. These positive results were sustained for 52 weeks, with no new safety signals identified. Innovent plans to submit a New Drug Application (NDA) to China's National Medical Product Administration (NMPA). This successful trial positions picankibart as a potential best-in-class treatment with convenient dosing every 12 weeks.

Positive

• Picankibart achieved over 80% PASI 90 improvement at week 16 in Phase 3 trial.
• At week 52, 84.9% of participants maintained PASI 90 and 85.9% achieved sPGA 0/1.
• All key secondary endpoints met, including improvements in quality of life metrics (DLQI).
• Favorable safety profile with no new safety signals identified.
• Innovent plans to submit NDA to NMPA, targeting a significant market opportunity.
• Picankibart requires only 5-6 doses annually, enhancing patient convenience.

Negative

• The trial was to Chinese subjects, potentially requiring more diverse demographic data for global approval.
• Long-term safety data beyond 52 weeks is still pending.

SAN FRANCISCO and SUZHOU, China, May 27, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today 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."

About Psoriasis

Psoriasis is a chronic, recurrent, inflammatory and systemic disease mediated by both genetic and environmental factors, which can occur in all age groups with no gender preference. The typical clinical presentation includes scaly erythema or plaque with non-infections, localized or widespread distribution. It is a life-long noninfectious condition, which is very difficult to treat. Psoriasis can be classified into psoriasis vulgaris (including guttate psoriasis and plaque psoriasis), pustular psoriasis, erythrodermic psoriasis and arthropathic psoriasis. Approximately, 80~90% of patients have plaque psoriasis, and nearly 30% of the cases are moderate and severe. There are significant differences in the prevalence of psoriasis around the world, with more than 6 million patients in China. At present, in China, the main systemic treatments include methotrexate (MTX), cyclosporine A, retinoic acids and biological agents. Since 2019, psoriasis treatment in China has gradually entered the era of biological agents.

About picankibart (IBI112)

Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent, with independent intellectual property rights. This product specifically binds to IL-23p19 subunit, thereby preventing IL-23 from binding to cell surface receptors. Picankibart may provide a more effective treatment option for patients with psoriasis or other autoimmune diseases.

In May 2024, picankibart 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.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. 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 early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).

Forward-looking statement

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

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SOURCE Innovent Biologics

FAQ

What is picankibart (IBI112) and what does it treat?

Picankibart (IBI112) is a recombinant anti-IL-23p19 antibody injection developed by Innovent Biologics for treating moderate to severe plaque psoriasis.

What were the primary endpoints achieved by picankibart in the Phase 3 CLEAR-1 trial?

Picankibart met the primary endpoints of achieving PASI 90 and sPGA scores of 0 or 1 at week 16.

How long were the results of picankibart sustained in the study?

The results of picankibart were sustained through week 52.

What is the dosing interval for picankibart in treating psoriasis?

Picankibart is administered every 12 weeks after initial doses at weeks 0, 4, and 8.

What are the next steps for Innovent Biologics after the successful Phase 3 trial?

Innovent plans to submit a New Drug Application (NDA) to China's NMPA based on the trial results.

What is the stock symbol for Innovent Biologics?

The stock symbol for Innovent Biologics is IVBIY.