Innovent Biologics and UNION therapeutics have announced the first participant dosing in a Chinese Phase I study of a next-generation PDE4 inhibitor, orismilast (IBI353).
The multiple dose escalation Phase I study has been designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of orismilast in healthy Chinese participants after giving multiple doses of a PDE4 inhibitor.
This will support the subsequent clinical development of the inhibitor in several indications, including atopic dermatitis (AD) and psoriasis.
Orismilast has a high potency for the PDE4 subtypes connected to inflammation.
Last year, the company entered into a strategic cooperation with UNION therapeutics for the exclusive rights of orismilast to research, develop, and commercialise in China, including Hong Kong, mainland China, Macao. and Taiwan.
Innovent Clinical Development vice-president Dr Lei Qian said: “There is currently no cure for psoriasis, and there is a great unmet clinical need in this field.
“The results of ex-China clinical studies have demonstrated that orismilast has a good safety profile and biological activity.
“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 fulfil the needs of safe, effective, and convenient long-term oral treatment for patients, thus significantly reducing the disease burden of patients and their pain.”
The company stated that the PDE4 inhibitor has generated positive proof of concept (PoC) data in psoriasis, when given orally, and in AD, when given topically.
Orismilast is currently being developed as a potential best- or first-in-class oral therapy option for psoriasis and AD.