Jyong Biotech Announces Completion of Primary Endpoint Statistical Analysis for Phase II Clinical Trial of MCS-8 With Positive Outcomes

Core Insights - Jyong Biotech Ltd. has achieved a significant milestone in the development of its plant-derived new drug MCS-8 (PCP), focusing on treating urinary system diseases, particularly prostate cancer [1][6] Clinical Trial Results - The Phase II clinical trial of MCS-8 (PCP) involved over 700 high-risk subjects and demonstrated a 27.3% reduction in prostate cancer incidence compared to placebo [2][8] - The trial also showed a 17.1% reduction in the incidence of high-grade prostate cancer (Total Gleason Score ≥ 7) compared to placebo [3][8] - Safety assessments indicated no increase in adverse event rates, with no serious adverse events related to MCS-8 observed [8] Safety and Efficacy - In the MCS-8 group, favorable lipid-modulating trends were observed, including a significant decrease in triglycerides (P = 0.05), a decrease in LDL (P = 0.018), and an increase in HDL (P = 0.003) [4][8] - The placebo group experienced a significant increase in fasting glucose (P = 0.022), while no significant differences were noted in liver function, kidney function, or blood pressure [4][8] Future Development Plans - The company plans to initiate a global Phase III trial in collaboration with international pharmaceutical companies to further validate the clinical potential of MCS-8 [6] - The company has adhered to U.S. FDA guidelines throughout the development process, ensuring rigorous scientific validation and clinical testing [5] Company Overview - Jyong Biotech Ltd. is a science-driven biotechnology company based in Taiwan, focusing on developing innovative plant-derived drugs for urinary system diseases, with initial markets in the U.S., EU, and Asia [1][9] - Since its inception in 2002, the company has built integrated capabilities across drug development, including discovery, clinical trials, regulatory affairs, and commercialization [9]