Innovent Biologics, Inc. and UNION therapeutics A/S announced that the first Chinese healthy volunteer has been successfully dosed in the Phase I study of orismilast (Innovent R & D code: IBI353), a potential best-in-class PDE4 inhibitor in global clinical Phase II stage. This study (CTR 20222393) 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.