QY201, an orally administered tablet, is a new generation JAK1/TYK2 inhibitor independently developed by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. (hereinafter referred to as "EnitiateBio") has entered the phase II clinical trial.
This is a multi-center, fully-randomized, double-blind, placebo-controlled, parallel-group, 12-week treatment period phase II clinical study, aiming to evaluate the efficacy, safety, and population pharmacokinetic characteristics of QY201 tablets in adult patients with moderate-to-severe atopic dermatitis, and to provide basis for dose selection in phase III clinical trial.
Led by Professor Wu Liming from the Department of Dermatology at Hangzhou First People's Hospital, this Phase Two clinical study is being carried out successively in about 33 research centers nationwide with a planned enrollment of 200 patients with moderate-to-severe atopic dermatitis. On July 17, 2023, Professor Li Linfeng‘s team from the Department of Dermatology from Beijing Friendship Hospital, Capital Medical University enrolled the first patient.
QY201 is a class 1 new drug with global intellectual property rights developed by EnitiateBio. It is an oral JAK inhibitor that inhibits JAK-STAT signaling by suppressing JAK activity, reduces the expression of proinflammatory cytokines, and thus exerts therapeutic effects on autoimmune diseases such as atopic dermatitis and psoriasis. QY201 tablets have high selectivity and potent activity against JAK1 and TYK2, indicating a lower risk of toxicity caused by inhibiting kinase targets. The completed clinical data of phase Ia study in healthy subjects and phase Ib study in patients with moderate-to-severe atopic dermatitis demonstrated good overall safety and tolerability of QY201 tablets. The phase Ib study showed encouraging preliminary therapeutic results, with rapid relief of pruritus and improvement in skin lesions.
Dr. Shi Jun, CMO of EnitiateBio, said that,
"The clinical development of QY201 oral tablets holds top priority in EnitiateBio’s pipeline and has broad application prospects. Atopic dermatitis was selected as the initial indication. EnitiateBio has always adhered to a differentiated R&D strategy, screening for candidate molecules that are safer or more effective than previous generation JAK inhibitors at the discovery stage. In clinical development, we select the most suitable indications based on the molecular targeting characteristics and disease biology, then further optimize the indication spectrum according to domestic and foreign clinical needs, market value and development priorities, and initiate development at the right time. QY201 oral tablets has recently completed a phase Ib study in patients with moderate-to-severe atopic dermatitis, and the ongoing phase II study will provide a basis for dose selection for the phase III registration study. At the same time, we have also formulated a meticulous overseas development plan, and submitted an IND in the US for a unique dermatological indication ranked top 3-5 in the world. I am very much looking forward to QY201 as a best-in-class next generation JAK inhibitor."
Mr. Kevin Ding, CEO of EnitiateBio, said that,
"I am particularly thankful to the patients and experts for their support and help. The phase Ib clinical trial of QY201 went through many difficulties and finally achieved encouraging efficacy and clinical data. The participation of each patient is extremely valuable to the EnitiateBio team. Every piece of information has been invested in tapping into the full clinical potential of QY201. This has laid a solid foundation for the development of phase II clinical trial, and we look forward to witnessing more clinical trial results of QY201 together with more researchers, frontline clinical personnels and patients.
About EnitiateBio
Founded in 2020, EnitiateBio (Hangzhou) Co., Ltd. is an innovative pharmaceutical company that focuses on innovative drugs for autoimmune diseases, develops breakthrough drugs through independent research and development and strategic cooperation, and is committed to addressing the unmet needs of patients and improving the quality of human life.
The company is headquartered in Hangzhou, Zhejiang, and has set up a clinical center and a R&D center in Shanghai. EnitiateBio is a key introduction project of the Linping National Economic and Technological Zone in Hangzhou. It won the first prize in the "2020 Hangzhou Overseas High-Level Talent Innovation and Entrepreneurship Competition (Life and Health Group)" and received about 0.1 billion ren-min yuan of angel investment from healthcare focused industrial capital Betapharm. EnitiateBio also established a strategic partnership with Betapharm to jointly promote the clinical development of its drug candidates. In 2022, the company completed Series A financing of nearly 100 million CNY.
Upholding the values of "embracing competition, relentless pursuit, and candid dedication", EnitiateBio has assembled a team of scientists with successful new drug whole-phase development experience from early new drug research and development to clinical translation, and clinical management. The company owns global patents for several innovative Class 1 drug candidates including QY201, QY101 and QY211, with multiple indications rapidly advancing into different clinical stages, and several IND filings are on the horizon. The company pays attention to the unmet clinical needs, independently develops differentiated molecules, and has a prospective portfolio in autoimmune diseases. Through tireless efforts, EnitiateBio strives to become a leader in the development of innovative drugs for autoimmune diseases.
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