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.”

  1. Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Disease-a-Month. 2019; 11: 53.
  2. 阎鹏光, 李景南. 溃疡性结肠炎的规范诊治[J]. 中华内科杂志, 2021, 60(6):4.

About Asieris

Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve patient’s dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.

The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.

Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.