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 cases 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^[1]. In China, the incidence of UC is on the rise and is about 1.45 to 2.0 per 100,000 people per year^[2].

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 thrilled to have received IND approval for APL-1401 as a treatment for UC from the NMPA," said Dr. Linda Wu, Chief Development Officer of Asieris, "This milestone opens up the possibility for APL-1401 to potentially provide a novel and effective treatment avenue for ulcerative colitis patients in China. Furthermore, it has enhanced Asieris' expertise and technological capabilities in the realm of gastrointestinal diseases. We will swiftly commence clinical trials in China, with the goal of offering patients a wider array of advanced medication choices as quickly as we can."