Shanghai, China, December 4, 2025 — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on genitourinary tumors and women’s health, announced that the results from the Phase Ib clinical study of its oral drug APL-1401 for the treatment of moderate-to-severe active ulcerative colitis (UC) were selected for the 19th European Colorectal Congress (ECC), and the clinical data from the study were released in a poster presentation.
The study is a Phase Ib randomized, double-blind study conducted in patients with moderate-to-severe active ulcerative colitis to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of APL-1401. The dose escalation of the study has been completed, showing a favorable safety profile and positive efficacy signals within only a 4-week treatment period. Among all evaluable patients, 41.7% (5/12) achieved histologic improvement, with the 120 mg cohort standing out prominently, showing a clinical response rate of 33.3% and a histologic improvement rate of 66.7% within the 4-week treatment period, with no improvement observed in the placebo group. Additionally, signs of early (4-week) endoscopic improvement were observed in the 120 mg dose cohort, with 33.3% of patients achieving a 1-point reduction in the Mayo Endoscopic Subscore (MES) and 100% of patients achieving a 1-point reduction in rectal bleeding subscores. Based on the above positive results, the company has initiated an extension study of the 120 mg dose cohort to evaluate the efficacy of this potential first-in-class therapy over a 12-week treatment period, thereby laying a more sufficient foundation for subsequent clinical studies, with the aim of providing patients with a novel treatment option.
APL-1401 at 120 mg once daily was well tolerated and showed preliminary efficacy signals over 4 weeks in patients with moderately to severely active UC. These findings support expansion of the 120 mg cohort to 12 weeks to further evaluate its safety and therapeutic potential.
APL-1401 is a potent and selective dopamine β-hydroxylase (DBH) inhibitor. It is an innovative oral drug independently researched and developed by the company, featuring a novel mechanism of action for the treatment of UC. UC is a chronic idiopathic inflammatory bowel disease (IBD) of the colon that causes superficial mucosal inflammation. Globally, approximately 5 million patients suffer from UC, with about 49% experiencing moderate-to-severe symptoms. This drives increasing demand for biological agents and targeted therapies. As of 2023, the global prevalence of UC continues to show a persistent upward trend1-3. According to Mordor Intelligence’s global UC market research, the market is projected to reach USD 10.56 billion in 2025 and increase to USD 13.21 billion by 2030, representing a Compound Annual Growth Rate (CAGR) of approximately 4.6%4.
The inflammatory nature of UC can lead to persistent intestinal damage, increasing the risks of hospitalization, surgery, and colorectal cancer. Currently, there is no cure for UC, and the efficacy and safety of existing therapies leave room for further improvement. There remains a significant unmet medical need, necessitating novel mechanism-based treatments.
Ms. Joanna Zhang, Chief Medical Officer of Asieris Pharmaceuticals, said, “We are pleased that these study data have been recognized on the international academic platform of ECC. These positive early results reinforce our confidence in APL-1401’s innovative mechanism of action. We are moving quickly to advance this potential first-in-class therapy to address the urgent unmet clinical needs of UC patients.”
Reference：
1. Ng SC, Shi HY, Hamidi N, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2018;390(10114):2769-2778.
2. Kaplan GG, Windsor JW. The four epidemiological stages in the global evolution of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2021;18(1):56–66.
3. Alatab S, Sepanlou SG, Ikuta KS, et al. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet Gastroenterology & Hepatology. 2020;5(1):17–30.
4. Ulcerative Colitis Market Size, Trends, Share & Growth Drivers 2030
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 women’s health. 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.
Through proprietary R&D and strategic collaborations, the company is committed to developing first-in-class drugs and other innovative technologies and products that address significant unmet medical needs, building a robust portfolio spanning from disease diagnosis to treatment within its focused therapeutic areas. Driven by patient needs, we are comprehensively advancing Commercialization 2.0 to improve the accessibility and affordability of innovative products, thereby benefiting more patients in China and globally.