Asieris Obtained IND Approval from US FDA for APL-1401, a New Drug for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Shanghai, China, 10 November 2022 – Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs, announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its oral drug APL-1401 for the treatment of moderately-to-severely active ulcerative colitis (UC).

The company will begin enrollment soon for this clinical study in the United States, and will submit an CTA application to the National Medical Products Administration (NMPA) of China in the near future.

The study is a randomized, double-blind Phase Ib study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of APL-1401 in patients with moderate to severely active UC .

UC is a chronic idiopathic inflammatory bowel disease (IBD) of the colon. The disease causes superficial mucosal inflammation in a continuous fashion extending from the rectum to the more proximal colon, to varying degrees. The overall incidence and prevalence of UC are reported to be 1.2-20.3 and 7.6-245 per 100,000 people for the years from 2000 to 2011. The annual incidence of UC ranged from 8.8 to 23.1 per 100,000 people per year in North America, and 0.6 to 24.3 per 100,000 people per year in Europe1. In China, the incidence of UC is on the rise and is about 1.45 to 2.0 per 100,000 people per year2.

The inflammatory nature of UC can result in continuous bowel damage with increased risks of hospitalizations, surgeries, and colorectal cancer. The goal of UC treatment focuses on improving the patients’ quality of life, inducing and maintaining clinical remission, achieving steroid-free remission, and minimizing the risk of cancer. There is currently no cure for UC, and there remains an unmet medical need for patients with UC.

“We are pleased to be granted IND approval for APL-1401 for the treatment of UC by the FDA. As the world’s first oral drug that modulates neurotransmitters to suppress inflammation independently developed by Asieris, APL-1401 will hopefully provide a new treatment for UC patients,” commented Dr. John Zhuang, Chief Operation Officer at Asieris, “APL-1401 was born from Asieris’s technology platform for immune regulation. We expect to get safety data and preliminary efficacy signal in this clinical study as soon as possible to support the subsequent clinical development of the product and clinical studies for other indications. Asieris remains committed to exploring cutting-edge technologies for innovative treatment mechanisms to respond to urgent medical needs and provide patients with more treatment options.”