Microbio Co., Ltd. announced on February 24 that its marketed drug "MS-20" significantly enhances the efficacy of standard-of-care (SOC) treatments for ulcerative colitis (UC). The investigational combination therapy demonstrated a clinical remission rate of 83.3%, a substantial improvement over the 35.7% observed with SOC alone, marking a 47.6% increase (P=0.021, Fisher’s exact test). This milestone follows MS-20’s previous success in tripling the response rate of Keytruda (PD-1) in late-stage lung cancer patients, reinforcing its therapeutic potential across multiple indications.
Robust Clinical Trial Design and Key Findings
The double-blind, placebo-controlled, randomized controlled trial (RCT) was conducted across four medical centers, enrolling 30 UC patients in a 1:1 ratio. Over a 12-week treatment period, the study assessed the efficacy of MS-20 in combination with SOC compared to a placebo control. The primary endpoint, clinical remission, was defined as achieving a post-treatment Partial Mayo Score (PMS) of 0-1, with the absence of rectal bleeding—indicating a return to normal daily function.
Microbio Co., Ltd.’s Vice President, Dr. Wan-Jiun Chen, noted that participants in the study had an average disease duration of 4.6 years. Notably, at just four weeks of treatment, 58.3% of patients receiving the MS-20-SOC combination had already achieved clinical remission, compared to only 7.1% in the placebo group (P=0.009, Fisher’s exact test), demonstrating a significantly accelerated therapeutic response.
Secondary endpoints further validated MS-20’s clinical benefits. Symptom relief rates—defined by normal stool frequency and absence of rectal bleeding—were achieved in 91.7% of MS-20-treated patients after 12 weeks, compared to 50.0% in the placebo group (P=0.036, Fisher’s exact test), indicating a statistically significant improvement in overall disease management.
Addressing Unmet Needs in Ulcerative Colitis Treatment
UC prevalence is increasing globally, particularly in Western countries, with a rising incidence in Asia, predominantly affecting adult males. Current treatments for mild-to-moderate UC rely on sulfa-based drugs, corticosteroids, and immunosuppressants, while moderate-to-severe cases often require biologics. However, treatment challenges include suboptimal disease control, high relapse rates, and the need for surgical intervention in 10-20% of patients.
The human gut microbiome has been increasingly recognized as a key factor in UC pathogenesis and treatment response. According to Dr. Chen, MS-20 exerts its therapeutic effects by modulating gut microbiota, restoring intestinal epithelial barrier integrity, and attenuating intestinal inflammation—addressing critical gaps in conventional UC therapies and improving patients’ quality of life.
Strategic Expansion and Future Market Prospects
MS-20 is currently an approved therapy for mitigating chemotherapy-induced side effects. Microbio Co., Ltd. is actively pursuing additional indications for immune-mediated and gastrointestinal diseases, supported by rigorous clinical trials to validate its therapeutic applications. The company aims to expand its global partnerships, leveraging MS-20’s demonstrated efficacy to establish a strong competitive position in the international biopharmaceutical market.
Resource:中天「上療漾」治潰瘍性腸炎試驗解盲達標，助升現用藥物臨床療效
