Jyong Biotech Reports Transformative Period of Clinical Validation and Commercialization Attempt: Phase II Data Focuses on Dual Therapeutic Potential of MCS-8 in Oncology and Metabolic Health, Alongside Strategic Market Entry into Asia

Core Insights - Jyong Biotech Ltd. has successfully completed a Phase II clinical trial for its lead candidate, MCS-8, demonstrating significant efficacy in prostate cancer prevention and potential metabolic benefits [2][3][4] Clinical Efficacy - The Phase II trial involved over 700 high-risk subjects and showed a statistically significant 27.3% reduction in overall prostate cancer incidence in the MCS-8 group compared to placebo [3] - There was a 17.1% reduction in high-grade prostate cancer incidence, which is critical as high-grade malignancies are the main cause of prostate cancer mortality [3] - Further analysis indicated a 35.2% reduction in positive biopsy cores and a 24.4% reduction in cancer-positive areas within those cores, suggesting MCS-8's effectiveness in reducing tumor burden [4] Metabolic Benefits - Patients treated with MCS-8 exhibited a statistically significant reduction in total cholesterol (P = 0.036) and improvements in lipid profiles, including decreased triglycerides (P = 0.05) and LDL levels (P = 0.018), along with increased HDL (P = 0.003) [4] - In contrast, the placebo group showed a significant rise in fasting glucose (P = 0.022), indicating MCS-8's potential in addressing metabolic dysregulation associated with prostate cancer [4] Safety Profile - The Phase II study indicated a favorable safety profile for MCS-8, with no serious adverse events reported and no negative impacts on blood pressure, liver, or kidney function over two years [5] - Analysis of Lactate Dehydrogenase (LDH) levels showed no significant increase in the MCS-8 group, suggesting cytoprotection and a lack of cellular toxicity [6] Commercialization Strategy - Jyong Biotech has initiated strategic partnerships in Asia, including a non-binding Letter of Intent with a South Korean pharmaceutical company for the in-licensing of MCS-2, aimed at navigating regulatory landscapes [7] - A Memorandum of Understanding has also been established with a pharmaceutical distributor in Vietnam to explore the regulatory and commercial pathway for MCS-2, targeting a market with increasing demand for urological therapeutics [8] Management Perspective - The Chairwoman and CEO of Jyong Biotech emphasized the transformation of the company into one with clinically validated assets, highlighting the dual benefits of MCS-8 in reducing cancer incidence and improving metabolic health [9]