Innovent and UNION Therapeutics announced the completion of the first patient dosing of a novel PDE4 inhibitor, Orismilast (IBI353), in a Phase I clinical trial in China

ROCKVILLE, USA, Suzhou, China, and HEILEUP, Denmark, Dec.
5, 2022 /PRNewswire/ -- Innovent Biopharmaceutical Group (HKEx stock code: 01801), a biopharmaceutical company dedicated to the development, production and sale of innovative drugs in the field of major diseases such as oncology, autoimmunity, metabolism, ophthalmology, etc.
, has partnered with UNION therapeutics A/S ("UNION"), A multi-clinical stage pipeline focused on immunology and infectious diseases announced that orismilast (Innovent R&D code: IBI353), a potential best-in-class PDE4 inhibitor in a global Phase II clinical trial, completed the first subject dosing
in a Phase I clinical study in healthy subjects in China.

The study (CTR 20222393) is a Phase I dose-escalation clinical study with multiple doses in healthy subjects, the main objective of which is to evaluate the pharmacokinetic (PK) characteristics, safety and tolerability of Chinese healthy subjects after receiving multiple doses of orismilast, in order to support the subsequent clinical development
of orismilast in multiple indications such as psoriasis and atopic dermatitis (AD).

Orismilast is a potent and highly selective next-generation PDE4 inhibitor with a wide range of anti-inflammatory properties
.
In 2021, Innovent entered into a strategic partnership with UNION to acquire exclusive rights
to orismilast's research, development and commercialization in China, including Chinese mainland, Hong Kong, Macau and Taiwan.
Orismilast has generated positive proof-of-concept (PoC) data in oral treatment of psoriasis and topical treatment of atopic dermatitis, promising to be the potential best or preferred treatment
for both diseases.
The excellent therapeutic window provided by orismilast's high selectivity for PDE4 subtypes B and D and innovative sustained-release techniques compared to other PDE4 inhibitors is expected to result in better anti-inflammatory efficacy and tolerability
.

Dr.
Qian Lei, Vice President of Clinical Development of Innovent Biopharmaceutical Group, said: "There is currently no cure for psoriasis, and there is a great unmet clinical need
in this field.
Orismilast is an oral drug jointly developed by Innovent and UNION for the treatment of psoriasis and atopic dermatitis, and is another new target molecule deployed by Innovent in the field of autoimmunity, and is one of
the potential best drug candidates for Innovent that is currently in the middle of clinical development.
The results of foreign clinical studies have fully verified that orismilast has good safety and biological activity
.
As the first human trial of ORISMILAST in China, the Phase I study will evaluate the safety and tolerability of ORISMILAST in healthy Chinese people and provide a basis
for further clinical development 。 We will accelerate the entry of ORISMILAST into the clinical research of subjects with psoriasis and atopic dermatitis in China, with a view to obtaining approval as soon as possible, meeting the needs of patients for safe, effective and convenient long-term oral treatment, so that patients can benefit as soon as possible, while alleviating patients' pain, but also greatly reducing the medical burden of patients, and truly practicing Innovent's mission
of "developing high-quality biological drugs that ordinary people can afford".
"

Kim Kjøller, CEO of UNION therapeutics, said: "We are pleased that Innovent is fully committed to the development of orismilast, and we will work together to bring the next generation of innovative therapies
to patients with skin diseases around the world.
We have seen good progress in three late-stage clinical trials of orismilast for the treatment of psoriasis, atopic dermatitis and hidradenitis suppurativa (HS), and look forward to the ongoing Phase I study in China, an important step
forward in the development of orismilast.
" "