UNION therapeutics and Innovent announce first subject dosed in a Chinese clinical Phase 1 study of orismilast, a novel PDE-4 inhibitor

Hellerup, Denmark and ROCKVILLE, M.D., Suzhou, China, 5 December 2022 – UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases, and 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, today announced that the first Chinese healthy volunteer has been successfully dosed in the Phase 1 study of orismilast, a potential best-in-class PDE4 inhibitor in global clinical Phase 2 studies.

This study is a multiple dose escalation Phase I study in healthy volunteers aiming to evaluate the pharmacokinetic (PK) profile, safety and tolerability of orismilast in healthy Chinese subjects after multiple doses to support the subsequent clinical development of orismilast in multiple indications such as psoriasis and atopic dermatitis (AD).
 

Orismilast is a next-generation PDE4 inhibitor with high potency for the PDE4 subtypes linked to inflammation. In 2021, Innovent reached a strategic cooperation with UNION to obtain exclusive rights to the research, development and commercialization of orismilast in China (including mainland China, Hong Kong, Macao and Taiwan). Orismilast has generated positive proof of concept (PoC) data in psoriasis (administered orally) and in AD (administered topically) and is being developed as a potential best- or first-in-class oral treatment option in both diseases. Compared to other PDE4 inhibitors, the selectivity of orismilast for PDE4 subtypes B and D and the novel modified release delivery is expected to generate a favorable therapeutic window, potentially resulting in improved efficacy and tolerability.

Dr. Kim Kjøller, Chief Executive Officer of UNION therapeutics, stated: "We are excited by the strong advancement of orismilast by Innovent, which is essential in our joint efforts to provide this novel treatment to patients with dermatological diseases globally. We have seen good progress in our three late-stage clinical trials with orismilast for treatment of psoriasis, atopic dermatitis, and hidradenitis suppurativa, respectively. This, together with the now ongoing Phase 1 study in China, is important steps in the development of orismilast.”

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated: " There is currently no cure for psoriasis, and there is a great unmet clinical need in this field. Orismilast is a new target molecule Innovent laid out in the field of autoimmunity by co-development with UNION. It is potentially one of the best candidates in the mid-stage of clinical development at Innovent. The results of ex-China clinical studies have demonstrated that orismilast has good safety profile and biological activity. The ongoing Phase I study will evaluate the safety and tolerability of orismilast in Chinese healthy volunteers and provide the basis for further clinical development. We will accelerate the clinical development of orismilast in Chinese subjects with psoriasis or AD in order to obtain regulatory approval as soon as possible in China and to fulfill the needs of safe, effective and convenient long-term oral treatment for patients, thus significantly reducing the disease burden of patients and their pain. We will truly uphold our mission of “To develop and commercialize high-quality biopharmaceuticals that are affordable to ordinary people”.”

About orismilast

UNION is developing orismilast, which is a next-generation PDE4 inhibitor with high potency for the PDE4 subtypes linked to inflammation. It operates early in the inflammation cascade to induce a broad range of anti-inflammatory effects. Orismilast has the potential to inhibit many inflammatory pathways involved in dermatological and immunological diseases and holds potential to become a safe and efficacious treatment option in various dermatological and immunological diseases.

UNION is currently developing orismilast MR tablet for the treatment of psoriasis, AD and HS. UNION is progressing orismilast as a MR tablet to reduce the occurrence of gastrointestinal side effects typically associated with PDE4 inhibition.

In November 2020, the FDA cleared UNION’s Investigational New Drug (IND) application for orismilast MR tablet, and, in November 2021, the FDA granted Fast Track designation to orismilast MR tablet for the treatment of moderate to severe AD. Moreover, in September 2021, UNION entered into a strategic partnership and licensing agreement with Innovent Biologic for orismilast in Mainland China, Hong Kong, Macau and Taiwan. 

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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 in the fields of oncology, metabolic, autoimmune, 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 which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO®(adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), Pemazyre® (pemigatinib oral inhibitor), olverembatinib (BCRABLTKI), Cyramza® (ramucirumab) and selpercatinib. An additional 2 assets are under NMPA NDA review, 5 assets are in Phase 3 or pivotal clinical trials, and 20 more molecules are 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 and http://www.linkedin.com/company/innovent-biologics/  

About UNION therapeutics

UNION therapeutics is a privately held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with multiple candidates in clinical development. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and seasoned pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at www.uniontherapeutics.com