Innovent Announces First Patient Dosed in a Phase 3 Clinical Trial (CLEAR) of Picankibart (Anti-IL23p19 Monoclonal Antibody) in Patients with Moderate-to-Severe Plaque Psoriasis

Rhea-AI Summary

Innovent Biologics has successfully dosed its first patient in a Phase 3 clinical trial (CLEAR) for its anti-IL23p19 monoclonal antibody, picankibart (IBI112), targeting moderate-to-severe plaque psoriasis. This multicenter, double-blind study aims to enroll around 500 subjects over 68 weeks, assessing the drug's efficacy and safety against placebo. Previous Phase 2 results indicated significant clinical benefits, with up to 86% of participants achieving substantial improvements in skin condition. This trial marks a pivotal step in developing innovative psoriasis treatments in China, addressing unmet medical needs.

Positive

• First patient successfully dosed in Phase 3 trial for picankibart.
• Phase 2 results showed 66.7% to 86.0% of participants achieving PASI90.
• Study aims to address significant treatment gaps for psoriasis patients in China.

Negative

• None.

ROCKVILLE, Md. and SUZHOU, China, Feb. 15, 2023 /PRNewswire/ -- Innovent Biologics, Group. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announced that the first patient with moderate-to-severe plaque psoriasis has been successfully dosed in a Phase 3 clinical trial (CLEAR) of picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL23p19) antibody injection.

The CLEAR study (clinicaltrials.gov, NCT05645627) is a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical study to evaluate the efficacy and safety of picankibart in patients with moderate to severe plaque psoriasis. This study plans to enroll approximately 500 subjects with moderate to severe plaque psoriasis. After 4 weeks of screening, subjects who met the eligibility criteria of the study will be randomized in a 2:2:1 ratio to picankibart group 1 (initial dose of 200mg and subsequently 200mg every 12 weeks thereafter), picankibart group 2 (initial dose of 200mg and subsequently 100mg every 12 weeks thereafter), or placebo group. The research period is expected to be 68 weeks.

The CLEAR study is the first phase 3 clinical study of IL-23 class innovative drugs in China. Innovent will continue to leverage its leading position in clinical development and guarantee the high quality of innovative drugs, and strive to provide better treatment options for psoriasis patients as soon as possible.

Professor Yuling Shi of Shanghai Skin Disease Hospital, the Principal Investigator of the Study, stated, "Psoriasis is not only a skin disease, but also a systemic disease, with millions of patients in China. Due to the slow progression of the disease, the vast majority of patients require long-term treatment or even lifelong medication. The disease itself and its co-morbidities have a significant impact on the patient's quality of life, and even physical and psychological health. However, currently, for Chinese patients, the treatment needs are far from being met. Picankibart is a biological independently developed in China. Data from phase 2 clinical study have shown significant clinical benefit and improvement in quality of life for patients treated with picankibart. We look forward to the efficacy of picankibart in phase 3 clinical study, and also look forward to the launch of more domestic innovative drugs, benefiting more patients in China."

Dr. Qian Lei, Vice President of Clinical Development of Innovent, stated: "The new generation of drugs targeting IL-23 has shown excellent efficacy and good safety, especially compared with anti-IL-17 monoclonal antibody drugs. The long-term efficacy of IL-23p19 antibody drugs has made it a new choice for the treatment of psoriasis. Picankibart, independently developed by Innovent, is the first anti-IL23p19 antibody drug which has completed phase 2 clinical study in Chinese patients with moderate-to-severe plaque psoriasis, and has obtained good efficacy and safety results. It also showed the obvious advantages of long-dose interval and long-term efficacy. At week52, 66.7%~86.0% of the subjects who received picankibart achieving PASI90; 81.6%~88.0% of the subjects achieved PASI 75, and in one of the groups received picankibart, about 48.0 % of subjects achieved complete skin lesions clearance (PASI 100). Compared with current drugs on the market，picankibart shows a great potential for both efficacy and safety, and could be offered as a more optimal treatment option. Based on this, we are fully confident and will make all the efforts to advance the development of the CLEAR study, and plan to synchronize the use of the auto-injector in this study. We are striving to provide more convenient, user-friendly and effective treatment options for patients with moderate and severe plaque psoriasis as soon as possible".

About Picankibart (Anti-IL23p19 Monoclonal Antibody) 

Picankibart (R&D code: 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, resulting in the inhibition of the IL-23 receptor-mediated signaling pathway. Preclinical data demonstrated that picankibart has a clear target and well-elucidated mechanism of action and significant anti-inflammatory effect. Further, good safety and tolerability have been demonstrated in the phase 1 clinical study，and confirmed in the completed phase 2 clinical study, showing long-dose interval and long-term efficacy advantages. Picankibart is expected to provide more effective treatment options for patients with autoimmune diseases, including psoriasis.

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, first-line treatment of psoriasis in China has gradually entered the era of biological agents.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform that includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 36 valuable assets in the fields of cancer, autoimmune, metabolic, ophthalmology and other major therapeutic areas, among them, 7 varieties were selected for the national "Major New Drug Creation" special project, 8 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), Pemazyre® (pemigatinib oral inhibitor) ,olverembatinib (BCR-ABL TKI) ,Cyramza® (ramucirumab) and Retsevmo®( selpercatinib), 3 asset under NMPA NDA review, 6 assets in Phase 3 or pivotal clinical trials, and an additional 19 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center, and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.

Note:

TYVYT® (Sintilimab Injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), and SULINNO® (adalimumab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer:

1.  This indication is still under clinical study and hasn't been approved in China.

2.  Innovent does not recommend the use of any unapproved drug/indication.

Forward-Looking Statements

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, are intended to identify certain of such forward-looking statements. Innovent 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 Innovent 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 Innovent'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, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent 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 materialize or turn out to be incorrect.

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SOURCE Innovent Biologics

FAQ

What is the purpose of the CLEAR study for picankibart (IVBIY)?

The CLEAR study aims to evaluate the efficacy and safety of picankibart in treating moderate-to-severe plaque psoriasis.

How many patients are expected to be enrolled in the CLEAR study?

Approximately 500 patients will be enrolled in the CLEAR study.

What were the results of the Phase 2 trial for picankibart (IVBIY)?

The Phase 2 trial indicated significant improvements, with 66.7% to 86.0% of participants achieving PASI90.

What is the expected duration of the CLEAR study for picankibart?

The research period for the CLEAR study is expected to last 68 weeks.

When was the first patient dosed in the CLEAR study for picankibart (IVBIY)?

The first patient was dosed on February 15, 2023.