SHANGHAI—Reistone Biopharma Company Limited announced today the dosing of the first patient in their Phase 2 global clinical trials of SHR0302 in patients with ulcerative colitis and Crohn’s disease, respectively. The Phase 2 studies are randomized, double-blind, placebo-controlled, four arms parallel, multicenter studies to investigate the safety and efficacy of SHR0302 in patients with moderate-to-severe active ulcerative colitis and Crohn’s disease.
“We are excited to advance our selective JAK1 inhibitor into our global Phase 2 trials for ulcerative colitis and Crohn’s disease. Reistone is committed to bringing this innovative drug developed in China to the world,” said Dr. Min Irwin, chief executive officer and cofounder of the company.
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’s estimated that there are at least 2 million people suffering from ulcerative colitis, and one million people suffered from Crohn’s disease globally.
Despite recent advances in treatment, there is still significant unmet medical need in this area. Several treatments for the disease have been approved, including biological agents such as anti-TNF and anti-IL-12/23, which have improved the IBD therapeutic landscape. But there is still an unmet need for patients suffering from high recurrence and complex clinical manifestations of IBD.
“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,” noted 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, a novel, potent, orally administered selective Janus kinase 1 (JAK1) inhibitor, is in development as a treatment for IBD. JAK inhibitors function by interfering the JAK-STAT signaling pathway via blocking the Janus Kinase enzyme family which includes JAK1, JAK2, JAK3 and TYK2. However, inhibiting JAK2 kinase causes the unwanted side-effect of lowering hemoglobin, lymphocyte and neutrophil counts. Therefore, a highly selective JAK1 inhibitor may have an improved safety profile while maintaining anti-inflammatory effect.
JAK1 selectivity could potentially provide a favorable safety and efficacy profile, compared to the pan-JAK inhibitor. Studies have shown that JAK1 inhibitors positively contribute to the effectiveness of anti-inflammatory therapies. 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 SHR0302 from Jiangsu Hengrui Medicine Co Ltd., and owns the global rights for multiple indications of autoimmune diseases. Back in October 2018, Reistone received U.S. FDA approval for the Phase 2 clinical trial to investigate the efficacy and safety of SHR0302 in UC. The approval was the first step to enable the initiation of the clinical program in China, the U.S. and several European countries simultaneously.
“Millions of people suffer from UC and many have recurrent and relapsing diseases that severely affect their life,” mentioned Irwin mentioned in a press release. “The FDA IND approval of SHR0302 in the United States for Phase 2 clinical development is an important starting point for Reistone, which demonstrates our capability to design and manage global clinical studies in collaboration with top global medical experts.”