Reistone Biopharma announced dosing of the first patient in their Phase II global clinical trials (RSJ10101 and RSJ10201) of SHR0302 in patients with Ulcerative Colitis and Crohn's disease respectively. The Phase II studies are randomized, double-blind, placebo-controlled, four arms parallel, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Ulcerative Colitis and Crohn's Disease.
Inflammatory Bowel Diseases (IBD) are a group of chronic progressive, inflammatory, autoimmune diseases affecting the gastrointestinal system. Ulcerative colitis (UC) and Crohn's disease (CD) are the two main types of IBD. It is estimated there are at least 2 million people suffering from Ulcerative Colitis, and one million people suffered from Crohn's disease globally. Despite recent advancement in treatment, there is still a significant unmet medical need in this area. In 2016, the global Ulcerative Colitis and Crohn's disease markets were estimated at about $5 billion and $10 billion US dollars respectively.
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"We are excited to advance our selective JAK1 inhibitor into our global Phase II trials for UC and CD. Reistone is committed to bringing this innovative drug developed in China to the world," said Dr. Min Irwin, CEO and Co-Founder of the company.
"There are still high levels of unmet medical need for UC and CD treatment. Despite anti-TNF agents being entrenched in the treatment of UC and CD, there remains a significant number of patients who lose response to these biological drugs. High cost of using these biologics is another issue," said Dr. Aik Han Goh, Reistone's Chief Medical Officer. "Small molecule drugs, such as SHR0302, potentially provide a new alternative treatment resolution for the patients."
SHR0302 is a novel, potent, orally administered selective Janus kinase 1 (JAK1) inhibitor in development as a treatment for inflammatory bowel diseases. JAK1 selectivity could potentially provide a favorable safety and efficacy profile compared to the pan-JAK inhibitor. Longer-term clinical studies are ongoing to confirm a favorable risk-benefit of JAK1 selectivity by avoiding the hematological side effects related to JAK2 inhibition. Reistone licensed in the drug from Jiangsu Hengrui Medicine Co Ltd (Hengrui) and owns the global rights for multiple indications of autoimmune diseases.