Innovent Biologics and UNION Therapeutics announce first dosing of Chinese subject in phase 1 study
pharmafile | December 5, 2022 | News story | Research and Development |
Innovent Biologics, a biopharmaceutical company which develops, manufactures and commercialises medicines for the treatment of illnesses within the scope of oncology, autoimmune, metabolic and opthamology, along with UNION Therapeutics, a privately-held clinical stage pharmaceutical development company focused on immunology and infectious diseases, have announced that the first healthy Chinese subject has been dosed with orismilast, a potentially best-in-class PDE4 inhibitor.
Orismilast has previously demonstrated positive proof-of-concept data in psoriasis (administered orally) and in atopic dermatitis (AD) (administered topically). It is also being developed as a potential best- or first-in-class oral treatment option in both diseases. Orismilast will focus on the PDE4 subtypes B and D, and have a novel modified releases delivery ‒ both meaning it is expected to generate a favourable therapeutic window compared to other PDE4 inhibitors.
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 1 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 commercialise high-quality biopharmaceuticals that are affordable to ordinary people’.”
Kim Kjøller, CEO 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 suppurative, respectively. This, together with the now ongoing phase 1 study in China, is important steps in the development of orismilast.”
James Spargo
