Enrollment goal met in trial of MCS-8 for prostate cancer prevention

The target enrollment has been reached in a phase 2 clinical trial (NCT02042807) of MCS-8, an investigational agent for prostate cancer prevention, Jyong Biotech announced in a news release.¹

In total, the trial enrolled over 700 high-risk participants across 20 clinical trial sites in Taiwan. The study also includes participation from more than 130 urologists.

“We are pleased to have reached this key milestone in the MCS‑8 development program,” said Fu-Feng Kuo, chairwoman and CEO of Jyong Biotech, in the news release.¹ “We have enrolled over 700 participants in this clinical trial, and despite the challenging times of the COVID-19 pandemic, we have successfully achieved this milestone and the progress has been ahead of our expectations. This truly reflects the team's professionalism, patience, dedication, and commitment.”

Overall, the double-blind, randomized, placebo-controlled study is assessing the safety and efficacy of MCS-8 for the prevention of prostate cancer.

To be eligible for enrollment, participants needed to be aged 50 to 75 years and have a high-risk of prostate cancer. Participants were excluded from the study if they had a history of prostate cancer, a prostate-specific antigen level greater than 10.0 ng/mL, or if they were currently or planning to take long-term hormonal agents that may affect the normal physiology of sex hormone function.

Those included in the study were randomly assigned to receive MCS soft capsules at the dose levels of 15 mg/day or 30 mg/day or to placebo. The primary end point is the cumulative biopsy-detectable prostate cancer rate at week 104 (month 24).

Initial Data on MCS-8

Topline results from the phase 2 trial of MCS-8 were recently presented at the 22nd Urological Association of Asia Congress in Taipei City, Taiwan.³

Overall, the study 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 treatment-related adverse events reported.

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

REFERENCES

1. Jyong Biotech announces completion of patient enrollment of over 700 subjects in phase II clinical trial of MCS‑8 for prostate cancer prevention. News release. Jyong Biotech Ltd. September 16, 2025. Accessed September 16, 2025. https://www.globenewswire.com/news-release/2025/09/16/3150776/0/en/Jyong-Biotech-Announces-Completion-of-Patient-Enrollment-of-over-700-subjects-in-Phase-II-Clinical-Trial-of-MCS-8-for-Prostate-Cancer-Prevention.html

2. To evaluate the effect of MCS in prostate cancer prevention (MCS-8). ClinicalTrials.gov. Last updated June 13, 2024. Accessed September 16, 2025. https://clinicaltrials.gov/study/NCT02042807

3. 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 September 16, 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