Asieris Pharmaceuticals, a global biopharma company specializing in discovering, developing and commercializing innovative drugs, announced that the US 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 Europe. In China, the incidence of UC is on the rise and is about 1.45 to 2.0 per 100,000 people per year.
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
