Positive Phase 2 Results for Reistone's JAK Inhibitor Demonstrate Significant Improvement in Patients with Moderate-to-Severe Ulcerative Colitis
SHANGHAI, Feb. 4, 2021 /PRNewswire/ -- Reistone Biopharma Co. Ltd. ("Reistone"), a clinical stage biopharmaceutical company focused on developing novel medicines for immuno-inflammatory, diseases with high unmet medical needs, today announced that SHR0302, an investigational selective Janus kinase type 1 (JAK1) inhibitor, met primary and key secondary endpoints in its Phase 2 Clinical Study (AMBER2) for the treatment of patients with moderate to severe ulcerative colitis (UC). AMBER2 is an international, double-blind, placebo-controlled trial conducted in 84 clinical research centers, in China, US, and Europe. This phase 2 study was designed to investigate the efficacy and safety of SHR0302 8 mg QD, 4 mg BID, and 4 mg QD in 164 adults with moderate to severe UC. The positive result in the efficacy and safety of SHR0302 observed in this trial supports the initiation of a Phase 3 program in 2021.
The AMBER2 study consisted of an 8-week induction period, followed by an 8-week extension period. The phase 2 study met its predefined primary endpoint of the percentage of patients who achieved a Clinical Response per the 9-point Mayo Score in all active arms, 8mg QD (46.3%), 4mg BID (46.3%), and 4 mg QD (43.9%) compared to placebo (26.8%) with statistically significant differences at week 8. All SHR0302 treatment arms demonstrated a statistically significant improvement in the percentage of patients who achieved Clinical Remission when measured by the 9-point Mayo Score, an FDA recommended standard endpoint for measuring disease remission. The improvements were 22.0% in 8mg QD, 24.4% in 4mg BID, and 24.4% in 4mg QD compared to 4.9% in placebo. Similar statistically significant improvements in clinical remission were observed when measured by the Total Mayo Score.
"The AMBER2 trial results are promising and reinforce the potential of a highly selective JAK1 inhibitor as a new treatment option for people suffering from Ulcerative Colitis. I am excited to see this product moving toward phase 3 clinical development" said Prof Bill Sandborn, AMBER 2 study steering committee member and Head of Gastroenterology and Director of the IBD Center, University of California, San Diego
In this study, the safety profile of SHR0302 was consistent with the selectivity of a JAK1 inhibitor and showed that all doses of SHR0302 were well-tolerated, with most adverse events (AEs) characterized as mild in severity. Treatment emergent adverse events (TEAEs) were broadly similar between the active treatments and placebo. Six cases of serious TEAEs were reported which were spread across both the active and placebo arms: 8mg QD (2 cases), 4mg BID (0 cases), 4mg QD (2 cases), and Placebo (2 cases). There were no reports of malignancy, death, pulmonary embolism (PE), or deep vein thrombosis (DVT) in this study.
"Ulcerative Colitis is a complex disease, but many patients are still unable to achieve satisfactory disease control, particularly those with moderate to severe conditions. A significant unmet medical need remains. We are very pleased with the results of the AMBER2 trial, which represents the second successful Phase 2 program completed by Reistone over the last three months" said Dr. Min Irwin, Co-Founder and CEO of Reistone. She added "Trials for new therapies for this disease are challenging in the best of times, but this global study was completed with the added challenge of the limitations imposed by the COVID-19 pandemic. This shows that our team has a strong capability to execute difficult and complex clinical trials with speed and integrity. We are proud of our clinical team, together with the study investigators, who have moved SHR0302 closer to becoming an important treatment option for this chronic disease."
About Ulcerative Colitis (UC)
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SOURCE Reistone Biopharma