Jyong Biotech Presents Positive Clinical Data for BOTRESO and MCS-8 at Urological Association of Asia Congress

Jyong Biotech Ltd. participated in the 22nd Urological Association of Asia Congress to showcase clinical data for its Phase III studies of BOTRESO and Phase II study of MCS-8 (PCP). The results showed significant improvement in lower urinary tract symptoms for BOTRESO in the Asian subgroup and pooled Taiwan-U.S. population. BOTRESO indicated excellent improvement and tolerance in four Phase III clinical trials, with no increase in adverse events or serious adverse events related to the drug. Jyong Biotech aims to develop and commercialize innovative and differentiated new drugs for urinary system diseases.

Jyong Biotech Ltd. (NASDAQ: MENS), a biotechnology company specializing in urinary system diseases, participated in the 22nd Urological Association of Asia Congress to present clinical data for its Phase III studies of BOTRESO and Phase II study of MCS-8 (PCP). The company showcased promising results, particularly for BOTRESO in treating benign prostatic hyperplasia (BPH).

BOTRESO, an oral botanical drug, demonstrated significant improvement in lower urinary tract symptoms (LUTS) in the Asian subgroup and pooled Taiwan-U.S. population, as reported by Jyong Biotech [1]. The Phase III clinical trials, consisting of two pivotal studies and two open-label extension studies, indicated no significant difference in the U.S. subgroup but showed statistical significance in the Asian subgroup and the pooled Taiwan-U.S. population. The 52-week extension studies confirmed long-term safety and efficacy with no serious adverse events, positioning BOTRESO favorably against current treatments like α-blockers and 5-α-reductase inhibitors [1].

The Phase II study of MCS-8 (PCP) also yielded positive results. The drug met its primary efficacy endpoints, showing lower rates of positive prostate biopsies and high-grade prostate cancer compared to placebo over 104 weeks. No treatment-related serious adverse events were observed, providing a strong basis for advancing MCS-8 into Phase III evaluation [1].

Jyong Biotech's business development activities, including letters of intent and licensing agreements with pharmaceutical partners, indicate strategic preparation for commercialization. The company aims to integrate Taiwan-U.S. clinical data for the New Drug Application (NDA) submission to the U.S. FDA, leveraging its global patent coverage and strong research capabilities [1].

The global BPH market is projected to reach $9.8 billion by 2026, up from $4.1 billion in 2020, highlighting substantial commercial potential. BOTRESO's mixed efficacy results suggest a potential regionally-targeted commercialization strategy might be optimal initially, focusing on Asian populations. The drug's primary competitive advantage appears to be its safety profile, with no increase in adverse events or serious adverse events related to the drug [1].

Jyong Biotech's advancement of MCS-8 for prostate cancer prevention represents a significant pipeline expansion beyond BPH treatment. The company's pursuit of global pharmaceutical partners for Phase III trials demonstrates an appropriate scale-up strategy for a prevention indication that will require large participant numbers and substantial resources [1].

References:
[1] https://www.stocktitan.net/news/MENS/jyong-biotech-ltd-participated-in-the-22nd-urological-association-of-7oczfulr33mm.html