TAIPEI, March 17, 2025 /PRNewswire/ -- Microbio Co., Ltd. (TPEx: 4128) today announced promising results from an exploratory clinical trial assessing MS-20 in combination with current medications for ulcerative colitis (UC). The primary endpoint, clinical remission at week 12, was achieved in 83.3% of patients receiving MS-20 as an add-on therapy, compared to 35.7% in the placebo group (placebo plus current medications). This 47.6% difference was statistically significant (P=0.021, Fisher's exact test).
These findings follow Microbio's recent announcement of a clinical trial evaluating MS-20 in combination with Keytruda (anti-PD1) for advanced non-small cell lung cancer (NSCLC). The trial showed a threefold increase in the objective response rate (ORR) with MS-20 and Keytruda (75%), including a complete response (CR) rate of 12.5%, compared to 25% for Keytruda alone. Additionally, median progression-free survival (PFS) has not yet been reached in the MS-20-Keytruda group, whereas it was 4.5 months with Keytruda alone.
This randomized, double-blind, placebo-controlled trial was conducted at four medical centers. A total of 30 UC patients were enrolled and randomly assigned in a 1:1 ratio to receive either MS-20 or a placebo for 12 weeks, both in combination with current UC medications. The primary outcome was clinical remission (partial Mayo score = 0 or 1, and rectal bleeding subscore = 0), a condition that allows patients to return to normal life.
"The average UC history of participants was 4.6 years. In addition to the significant improvement in the primary outcome - clinical remission at 12 weeks - the clinical remission rate at 4 weeks was already 58.3% in the MS-20 plus current medications group, compared to just 7.1% in the placebo plus current medications group," said Dr. Wan-Jiun Chen, Executive VP of Research & Development at Microbio. "These results suggest that MS-20 enhances the effectiveness of existing treatments and accelerates the treatment response, achieving significant remission within the first 4 weeks. This may help patients resume normal activities sooner."
For a secondary outcome, the symptomatic remission rate (stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0) in the MS-20 plus current medications group reached 91.7% after 12 weeks of treatment, compared to 50% in the placebo plus current medications group. This difference was statistically significant (P=0.036, Fisher's exact test).
Dr. Chen noted that while UC is more prevalent in Western countries such as Europe and the United States, its incidence is rising in Asia, particularly among adult men. Current treatments for mild-to-moderate UC include 5-aminosalicylates (5-ASA), corticosteroids, or combinations with immunomodulators, while biologics are added for moderate-to-severe cases. However, challenges remain, such as poor disease control and high recurrence rates, which necessitate surgical resection in 10 - 20% of cases.
"The human gut microbiota has been recognized as a key factor in the onset and treatment of ulcerative colitis. This trial demonstrated that MS-20 can reshape the gut microbiota, repair the gut epithelial barrier, and suppress intestinal inflammation - overcoming the limitations of conventional therapies to help manage UC and significantly enhance patients' quality of life," said Dr. Chen.
MS-20 is a postbiotic produced through the symbiotic fermentation of multi-strain probiotics and was initially approved to alleviate chemotherapy side effects. Microbio continues to conduct rigorous clinical trials evaluating MS-20 in combination with existing medications for immunological and gastrointestinal diseases.
About Microbio Co., Ltd.
Founded in 2000, Microbio (MB) specializes in immune, oncology, and metabolic diseases. The company focuses on research and development in microbiome science through its proprietary microbial pharmaceutical technology platforms. Its extensive library of anaerobic commensal bacterial metabolites has led to significant advancements in the treatment of immune, oncology, and metabolic diseases, driving the development of next-generation microbiome-based therapeutics.
About MS-20
MS-20 is a postbiotic developed through Microbio's Symbiota fermentation technology, involving the symbiotic fermentation of multi-strain probiotics under anaerobic conditions. It has been clinically proven to alleviate chemotherapy side effects and enhance the efficacy of immunotherapy. In 2024, MS-20 received self-affirmed GRAS status in the U.S. and is used in various food and beverage products, including specialized medical nutrition products.
SOURCE Microbio Co Ltd
