Home > Reistone Announces First Chinese Patient Dosed in a Phase II Clinical Study of JAK1 Inhibitor for Alopecia Areata
Reistone Announces First Chinese Patient Dosed in a Phase II Clinical Study of JAK1 Inhibitor for Alopecia Areata
Shanghai, China, July 31, 2020 / -- Reistone Biopharma Company Limited (“Reistone Biopharma”) today announced that, the first and second patients in China were enrolled and dosed in Dermatology Hospital of Southern Medical University in the phase II clinical trial of its product SHR0302 (a highly selective JAK1 inhibitor) used for alopecia areata.
The purpose of this phase II clinical study is to evaluate the safety and efficacy of SHR0302 tablet in adult patients with alopecia areata through international, multi-center clinical trials. This trial is being carried out simultaneously in China, the United States and Australia.
Alopecia areata is an autoimmune disease, and its clinical manifestation includes sudden unexplained alopecia localis or alopecia totalis, and formation of obvious patchy alopecia. According to the epidemiological statistics data, about 2% of people in the world suffer from alopecia areata, and there are about 4 million patients in China; 70-80% of the patients develop the disease before the age of 40, without gender or race difference. The pathogenesis of alopecia areata has not been fully identified, and its current treatment is limited without any cure method. It can easily cause a heavy mental burden on patients, which is a clinical problem and research hotspot that need to be resolved urgently.
Dr. Wu Yihan, Chief Medical Officer of Reistone Biopharma pointed out that, “as a highly selective JAK1 inhibitor, SHR0302 is expected to fill the gap in the field of alopecia areata treatment, breaking through the current situation of limited domestic treatments and no cure method, and providing a drug choice with a new mechanism of action for patients with alopecia areata who are intolerant or unresponsive to the existing treatments, thus improving the convenience and safety of medication for patients and further improving their quality of life.”
Dr. Min Wang Irwin, Chief Executive Officer of Reistone Biopharma also emphasized that, “enrollment of the first subject in China shortly after the initiation of the trial reflects the efficient cooperation among the research institute, investigators and the team of Reistone Biopharma, and also increases our confidence; the efficient and synchronous conduct of international, multi-center clinical trials demonstrates the feasibility and prospectiveness of international simultaneous clinical trials; we are looking forward to bringing more better products for patients.”
SHR0302 is a highly selective, small molecule JAK1 kinase inhibitor that is introduced from Hengrui Pharmaceutical by Reistone Biopharma, with its dosage forms of tablet and ointment currently under clinical development for several indications including ulcerative colitis, Crohn’s disease, atopic dermatitis and vitiligo, etc. Compared with pan-JAK inhibitors, SHR0302 may provide better safety and efficacy due to its high selectivity.
Reistone Biopharma Company Limited is a clinical stage biopharmaceutical company, focusing on the global R & D of innovative drugs for autoimmune diseases and inflammatory skin diseases, currently running 7 phase II studies and 1 phase I studies globally involving 4 products. Founded in January 2018 and headquartered in Zhangjiang, Shanghai, the company now has about 100 employees in China and the United States. For more information on Reistone Biopharma, please visit www.ReistoneBio.com