China-based Innovent Biologics Inc., (HKG: 1801) and Denmark-based partner Union Therapeutics A/S revealed that a first healthy volunteer has been dosed in a Phase I study in China for orismilast (IBI353), a potential best-in-class PDE4 inhibitor. The study (CTR 20222393) is a dose-escalation Phase I designed to assess 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: Mechanism and Development
Orismilast is a next-generation PDE4 inhibitor with high potency for the PDE4 subtypes linked to inflammation, currently at the Phase II stage in global trials. In 2021, Innovent reached a strategic cooperation with Union to obtain exclusive research, development, and commercialization rights to orismilast in Greater 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 for 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.-Fineline Info & Tech
