Positive data on BOTRESO and MCS-8 highlight dual advances in prostate health

Clinical data from Jyong Biotech’s investigational candidates in benign prostatic hyperplasia (BPH) and prostate cancer were recently shared at the 22nd Urological Association of Asia (UAA) Congress, the company announced in a news release.¹

The presentations featured results from several phase 3 studies of the oral botanical drug BOTRESO (MCS-2) for BPH and lower urinary tract symptoms (LUTS), as well as on the prostate cancer prevention drug MCS-8 (PCP).

Oral Botanical Drug for BPH

Topline data on the drug candidate BOTRESO (MCS-2) included results from 2 pivotal trials (NCT01002417 and NCT01002664) and 2 open-label extension studies (NCT01002222 and NCT01002274). The pivotal trials, conducted in the US and in a pooled Tawain-US population, randomly assigned patients to receive BOTRESO or placebo for 12 weeks. In the open-label extension studies, all patients were treated with BOTRESO for 1 year in order to assess the drug’s long-term safety.

In the US-based pivotal trial, data showed comparable efficacy between the BOTRESO and placebo groups in the intent-to-treat populations (those who received at least 1 dose of treatment). However, in the Asian (Taiwan) subgroup and in the pooled Taiwan-US population, patients in the BOTRESO arm experienced a statistically significant improvement in LUTS compared with patients in the placebo arm.

In the extension studies, BOTRESO “consistently showed long-term improvement from baseline,” according to Jyong Biotech. Patients in the BOTRESO arm did not experience an increased risk of adverse events (AEs) compared with patients in the placebo arm. Further, no serious drug-related AEs were reported.

Overall, the company noted that BOTRESO was well-tolerated across all 4 phase 3 trials.

According to Jyong Biotech, “This is the first case that a Taiwanese-developed oral botanical drug has been approved IND (Investigational New Drug) number from the U.S. FDA to proceed to Phase III clinical trials.” The company plans to submit a new drug application (NDA) for BOTRESO to the FDA, with integration of clinical trial data from Taiwan and the US.

Prostate Cancer Prevention Drug

Data on Jyong Biotech’s investigational agent in prostate cancer, MCS-8 (PCP), was also presented at the 22^nd UAA Congress. MCS-8 is being evaluated for the potential prevention of prostate cancer.

Overall, the phase 2 trial of the agent met its primary end point by demonstrating that receipt of MCS-8 was associated with lower rates of positive prostate biopsies and high-grade prostate cancer compared with placebo. The agent was also well-tolerated, with no serious AEs reported.

Pending regulatory guidance, the company plans to initiate a large-scale phase 3 trial of the agent to further assess its preventive potential.

REFERENCE

1. Jyong Biotech Ltd. participated in the 22nd Urological Association of Asia Congress to display the clinical data for its phase III studies of BOTRESO and phase II study of MCS-8 (PCP). News release. Jyong Biotech Ltd. August 22, 2025. Accessed August 22, 2025. https://www.globenewswire.com/news-release/2025/08/22/3137831/0/en/Jyong-Biotech-Ltd-Participated-in-the-22nd-Urological-Association-of-Asia-Congress-to-Display-the-Clinical-Data-for-its-Phase-III-Studies-of-BOTRESO-and-Phase-II-Study-of-MCS-8-PCP.html