Innovent Announces Phase 2 Clinical Study of Picankibart (IBI112) in Chinese Patients with Moderate-to-severe Plaque Psoriasis Met Primary Endpoint

SAN FRANCISCO and SUZHOU, China, Aug. 9, 2022 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, announces that the primary endpoint was met in a multicenter, randomized, double-blind, placebo-controlled phase 2 study (clinicaltrials.gov, NCT 05003531) of picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit antibody injection, in Chinese patients with moderate-to-severe plaque psoriasis.

This study (CIBI112A201) was designed to evaluate the efficacy and safety of picankibart under various administration in the treatment of moderate-to-severe plaque psoriasis. A total of 250 subjects were randomized 1:1:1:1:1 to receive 50 mg (once at week 0, 4, then every 12 weeks), 100mg (once at week 0, 4, then every 12 weeks), 100mg (once at week 0, 4, then every 8 weeks), 200mg (once at week 0, 4, then every 12 weeks) of picankibart or placebo. The primary endpoint of the study was the proportion of subjects who achieved a ≥90% improvement in the Psoriasis Area and Severity Index (PASI) at week 16 (PASI 90) and the total study period is 52 weeks. To date, a total of 245 subjects (98.0%) have completed the primary endpoint at week 16, and a total of 236 subjects (94.4%) have completed the visit at week 28.

• In terms of efficacy, 52.0%~54.9% of the subjects achieved PASI 90 after picankibart treatment at week 16, which was significantly higher than that in the placebo group and reached the primary endpoint, in addition, the proportions of subjects who achieved PASI 75 and PASI 100 were also significantly higher than that in the placebo group (all P-values＜0.001). The study results through 28 weeks showed a long-term efficacy of picankibart, with 61.2%~72.5% of the subjects who received picankibart achieving PASI 90, 78.4%~88.0% of the subjects achieved PASI 75, and in one of the groups received picankibart, about 40.0 % of subjects achieved complete skin lesions clearance (PASI 100).
• In terms of safety, picankibart is generally well tolerated, and no new safety signals occurred compared with previous clinical studies. The overall safety profile is similar to other IL-23p19 mAbs. The most frequently reported (incidence ≥10%) treatment-emergent adverse events were upper respiratory tract infection with mild to moderate severity.
• In addition, we observed a significant increase from baseline in the Dermatology Life Quality Index (DLQI) of subjects treated with each dose of picankibart compared to placebo (all P-values＜0.0001).

Clinical study results showed that 50-200mg picankibart administered every 12 or 8 weeks significantly improved the skin lesions and quality of life of subjects with moderate to severe plaque psoriasis, demonstrating the significant improvement effect at long-dose interval. It is worth noting that, at the 16-week primary endpoint assessment, subjects received only two administrations, significantly less than other similar biologics. Moreover, continued improvement in efficacy across the picankibart treatment was observed after reaching the primary endpoint (up to 28 weeks), demonstrating the potential sustained advantage of long interval dosing. The study period is 52 weeks (one year), and currently, subjects in the placebo group have been treated with IBI112, and the dosing and follow-up of the study are ongoing. Full data on the study will be published at future academic conferences or peer-reviewed journals.

Professor Jianzhong Zhang of Peking University People's Hospital, the principal investigator of the study, stated, "Psoriasis is a life-long disease, which has a huge impact on the physical and mental health and quality of life, while the current traditional treatment is not ideal. We are pleased to find significant clinical benefit and improved quality of life in subjects with moderate to severe plaque psoriasis in the phase 2 clinical study of picankibart. Meanwhile, picankibart also shows potential advantages in long dosing intervals and long-term efficacy. I am confident and looking forward to the success of its upcoming phase 3 study, and hope it will provide an alternative treatment option for Chinese psoriasis patients."

Dr. Lei Qian , Vice President of Clinical Development of Innovent, stated: "We are happy that phase 2 study of picankibart in Chinese patients with moderate-to-severe plaque psoriasis achieved primary clinical endpoint. As a new generation of IL-23p19 target drug, picankibart shows clear advantages in the long-dose interval and long-term efficacy. The dosing frequency is only 5 times annually, and it shows a great potential for both efficacy and safety, and could be offered as a more friendly treatment option compared to the current ones on the market whose dosing frequency is 7-16 times annually. Currently, there is no IL-23p19 target drug independently developed by Chinese pharmaceutical companies in the domestic market. We are greatly encouraged by the results of good efficacy, safety and tolerability of picankibart in the phase 2 clinical study. Based on this, we are confident and will actively advance the phase 3 clinical study of picankibart in patients with moderate to severe plaque psoriasis, and we plan to optimize the dosing regimen scientifically based on quantitative pharmacology to further improve efficacy, and synchronize the use of auto-injector in the phase 3 clinical study. We are striving to provide more convenient, user-friendly and effective treatment options for patients with moderate to severe plaque psoriasis as soon as possible and to fulfill our mission of providing high-quality innovative biopharmaceutical products that are accessible to patients."

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, resulting in the inhibition of the IL-23 receptor-mediated signaling pathway. Preclinical data demonstrated that IBI112 has a clear target and well-elucidated mechanism of action and significant anti-inflammatory effect. Further, good safety and tolerability have been verified in the phase 1 clinical study. At present, the phase 2 clinical studies of IBI112 in the indications of moderate to severe plaque psoriasis and ulcerative colitis are ongoing, and the primary clinical study endpoint has been met in the phase 2 clinical study of psoriasis, suggesting that it may provide a more effective treatment option for patients with psoriasis or other autoimmune diseases.

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 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 34 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, 7 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) and olverembatinib (BCR-ABL TKI) and Cyramza® (ramucirumab), 3 asset under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and an additional 20 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.

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.

3. The clinical study is ongoing, safety and efficacy profiles have not been fully established.

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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