Positive Phase 2 Results for Reistone’s JAK Inhibitor Demonstrate Significant Improvement in Patients with Moderate-to-Severe Ulcerative Colitis


SHANGHAI, Jan. 20, 2021—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.
AMBER2 study consisted of an 8-week induction period, followed by an 8-week extension period. The phase 2 study has 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. Additionally, all SHR0302 treatment arms also 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 also 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 III 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 with more treatment options becoming available in recent years, 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. I thank our clinical team, together with the study investigators, who have moved SHR0302 closer to becoming an important treatment option for this chronic disease.”

About SHR0302
SHR0302 is a potent and highly selective Janus kinase type 1 (JAK1) inhibitor and was in-licensed by Reistone from Jiangsu Hengrui Medicine Co., Ltd. Several late-stage clinical studies investigating SHR0302 are ongoing with both oral and topical dosage forms for several immune-inflammatory diseases including Ulcerative Colitis and Crohn's disease. The high selectivity of SHR0302 may potentially provide a favorable safety and efficacy profile compared to the pan-JAK inhibitors.

About Ulcerative Colitis (UC)
Ulcerative Colitis (UC) is a chronic, often debilitating Inflammatory Bowel Disease (IBD) that impacts millions of people worldwide. Approximately 750,000 people are living with UC in North America and diagnoses of the condition are on the rise globally. UC causes inflammation and ulcers (sores) in the digestive tract, affecting the innermost lining of the large intestine (colon) and rectum. Common symptoms of UC include abdominal pain, fever, weight loss and chronic, bloody diarrhea. UC can be debilitating and can sometimes lead to life-threatening complications. While it has no known cure, treatment can greatly reduce signs and symptoms of the disease and bring about long-term remission.

About Reistone
Reistone Biopharma is a clinical-stage biotech company focused on developing innovative medicines in autoimmune and immuno-inflammatory diseases. The company has a research and development pipeline of molecules with both known and novel biological targets for treating diseases with significant unmet needs. Reistone’s diverse pipeline focuses on novel drug candidates, some of which are currently under clinical investigation for immune-inflammatory diseases, including dermatological and gastrointestinal diseases. Further information about the company and its drug development programs and capabilities may be found at http://www.reistonebio.com or https://www.linkedin.com/company/reistone-biopharma.

Contact Information:

Aik Han Goh
Vice President
Chief Medical Officer

Qais Mekki
Senior Vice President
US Site Head and Head of International Development

Date of issue:2021-02-04 19:21
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