Taiwan-based Jyong Biotech Ltd. (Nasdaq: MENS) presented encouraging Phase III clinical trial results for its botanical drug candidate BOTRESO® at the 22nd Urological Association of Asia Congress, demonstrating statistically significant improvements in benign prostatic hyperplasia (BPH) symptoms in specific patient populations while maintaining a favorable safety profile.
Phase III Trial Results Show Regional Efficacy Differences
The Phase III clinical program for BOTRESO® comprised two pivotal placebo-controlled studies lasting 12 weeks, plus two open-label extension studies evaluating long-term safety over 52 weeks. In the Intention-to-Treat population, which included all patients who received at least one dose of study medication, results varied by geographic region.
While the U.S. subgroup showed no significant difference between BOTRESO® and placebo, the Asian subgroup from Taiwan and the pooled Taiwan-U.S. population demonstrated statistically significant improvement in lower urinary tract symptoms compared to placebo. The 52-week open-label extension studies revealed consistent long-term improvement from baseline across all participants receiving BOTRESO®.
Importantly, the incidence of adverse events did not increase in the BOTRESO® treatment group, and no serious adverse events related to the botanical drug were reported throughout the study period.
Addressing Safety Concerns with Current BPH Treatments
Current pharmacologic treatments for BPH face notable safety challenges. According to published literature in The Journal of Urology from February 2021, α-blockers and 5-α-reductase inhibitors have been associated with increased risk of heart failure. Additionally, a U.S. FDA Safety Announcement from June 9, 2011, noted a potential increased risk of high-grade prostate cancer with 5-α-reductase inhibitors.
BOTRESO® demonstrated excellent improvement and tolerance across all four Phase III clinical trials, potentially offering a safer alternative for BPH management. The botanical drug is locally developed in Taiwan and represents the first Taiwanese-developed oral botanical drug to receive an Investigational New Drug (IND) number from the U.S. FDA for Phase III clinical trials.
Significant Market Opportunity
The global BPH patient population has shown steady growth, increasing from 88.4 million in 2017 to 94.2 million in 2020, representing a 6.5% increase. In the United States specifically, the BPH patient population reached approximately 4.7 million in 2020, up 6.8% from 2017.
The corresponding market opportunity reflects this growing patient need. The global BPH drug market expanded from $3.7 billion in 2017 to $4.1 billion in 2020 and is projected to reach $9.8 billion by 2026.
MCS-8 Shows Promise for Prostate Cancer Prevention
Jyong Biotech also presented Phase II results for MCS-8 (PCP), a candidate for potential prostate cancer prevention. The Phase II trial met its primary efficacy analysis, with 104 weeks of administration associated with lower rates of positive prostate biopsies and high-grade prostate cancer compared to placebo. No MCS-8 treatment-related serious adverse events were observed.
The company believes these findings provide a basis for advancing MCS-8 into Phase III evaluation, subject to regulatory guidance. Jyong Biotech is currently in discussions with global pharmaceutical partners regarding further development of MCS-8, with goals of initiating large-scale Phase III trials involving thousands to tens of thousands of participants.
Regulatory and Commercial Strategy
Jyong Biotech has developed an additional drug substance (API-2) under the same patent as API-1 and is collecting all related Chemistry, Manufacturing, and Controls (CMC) documents per U.S. FDA requirements. The company intends to integrate Taiwan-U.S. clinical data for New Drug Application (NDA) submission to the U.S. FDA.
The company maintains global patent coverage for BOTRESO® across Asia, the Americas, and the European Union. Jyong Biotech has signed multiple letters of intent and licensing agreements with international pharmaceutical partners and continues to pursue collaborations and royalty-bearing partnerships to support global market entry.
All clinical research has been conducted in accordance with U.S. FDA guidance, positioning the company for potential regulatory submissions in multiple markets as it advances its botanical drug candidates through late-stage development.
