Shanghai, China, May 12th, 2024 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases, announced that the latest preclinical research findings of their independently developed oral medication APL-1401 for the treatment of active ulcerative colitis (UC) have been published in Cellular Immunology.
APL-1401 is a dopamine β-hydroxylase (DBH) inhibitor and an innovative oral medication for the treatment of UC with a novel mechanism of action. The study shows that APL-1401 regulates neurotransmitter levels by inhibiting DBH, and exerts a protective effect on the progression of colitis in rodents by regulating the neuro-immune axis. This positive result demonstrates the potential of APL-1401 to provide new therapeutic prospects of alleviating intestinal inflammation in patients.
UC is a chronic idiopathic inflammatory bowel disease (IBD) that affects the colon and causes superficial mucosal inflammation. The inflammatory nature of UC can result in continuous bowel damage with increased risks of hospitalizations, surgeries, and colorectal cancer. There is currently no cure for UC, and remains an unmet medical need for patients with UC.
IND application for the Phase Ib clinical study of APL-1401 for the treatment of moderate-to-severely active UC received approval from the U.S. Food and Drug Administration (FDA) in November 2022, and obtained clinical study approval from the National Medical Products Administration (NMPA) in August 2023. The study is being conducted simultaneously in 12 centers in China and the United States, aiming to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of APL-1401 in patients with moderate to severe active UC. We are actively progressing the study with partient recruitment, and seeking partners to collaborate on the global clinical development of APL-1401.
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.
