Microbio Co., Ltd. has announced promising results from an exploratory clinical trial evaluating MS-20 as an add-on therapy for ulcerative colitis (UC). The study demonstrated that MS-20 significantly enhanced the effectiveness of current UC medications, with 83.3% of patients receiving the combination therapy achieving clinical remission at 12 weeks, compared to just 35.7% in the placebo group (p=0.021).
The randomized, double-blind, placebo-controlled trial was conducted across four medical centers with 30 UC patients who had an average disease history of 4.6 years. Participants were randomly assigned in a 1:1 ratio to receive either MS-20 or placebo for 12 weeks, alongside their current UC medications.
Dr. Wan-Jiun Chen, Executive VP of Research & Development at Microbio, highlighted the rapid onset of action observed with MS-20: "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. These results suggest that MS-20 enhances the effectiveness of existing treatments and accelerates the treatment response."
Secondary outcomes also showed significant improvements. The symptomatic remission rate reached 91.7% after 12 weeks in the MS-20 group, compared to 50% in the placebo group (p=0.036). This measure, defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, is particularly important for patients' quality of life.
Understanding Ulcerative Colitis and Current Treatment Challenges
Ulcerative colitis is a chronic inflammatory bowel disease that causes inflammation and ulcers in the digestive tract, primarily affecting the colon and rectum. While more prevalent in Western countries, Dr. Chen noted that UC incidence is rising in Asia, particularly among adult men.
Current treatment approaches for UC vary based on disease severity. Mild-to-moderate cases typically receive 5-aminosalicylates (5-ASA), corticosteroids, or combinations with immunomodulators. For moderate-to-severe cases, biologics are often added to the treatment regimen.
Despite these options, significant challenges remain in UC management. Poor disease control and high recurrence rates continue to affect patients, with 10-20% eventually requiring surgical resection of affected bowel segments.
MS-20's Mechanism of Action
MS-20 is a postbiotic produced through Microbio's proprietary SymbiotaTM fermentation technology, which involves the symbiotic fermentation of multi-strain probiotics under anaerobic conditions.
"The human gut microbiota has been recognized as a key factor in the onset and treatment of ulcerative colitis," explained Dr. Chen. "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."
Broader Applications of MS-20
This successful UC trial follows Microbio's recent announcement of promising results from another clinical study evaluating MS-20 in combination with Keytruda (anti-PD1) for advanced non-small cell lung cancer (NSCLC). That trial showed a threefold increase in objective response rate with the combination (75% vs. 25% for Keytruda alone), including a complete response rate of 12.5%.
MS-20 was initially approved to alleviate chemotherapy side effects and received self-affirmed GRAS (Generally Recognized As Safe) status in the U.S. in 2024. It is currently used in various food and beverage products, including specialized medical nutrition products.
Future Directions
Microbio continues to conduct rigorous clinical trials evaluating MS-20 in combination with existing medications for immunological and gastrointestinal diseases. Founded in 2000, the company specializes in immune, oncology, and metabolic diseases, with a focus on microbiome science through its proprietary microbial pharmaceutical technology platforms.
The positive results from this UC trial suggest that MS-20 could become an important addition to the treatment arsenal for inflammatory bowel diseases, potentially improving outcomes and quality of life for patients who currently have limited effective options.
