Renascience Inc.
Notice of Completion of Patient Enrollment in Phase III Trial of Nivolumab Combined with RS5614 for Unresectable Malignant Melanoma
Announced completion of enrollment for 124 patients. After up to a 3-year observation period, primary endpoints will be evaluated and data analyzed and compiled into the clinical study report. Impact on the fiscal year ending March 2027 is currently unknown.
Key Figures
- Number of enrolled patients: 124 patients (target)
- Observation period: up to 3 years
- Orphan drug designation: Registered (2024/8/28)
AI要約
Clinical Trial Progress and Background
Renascience Inc. is conducting a physician-initiated Phase III randomized, placebo-controlled, double-blind clinical trial at 18 domestic sites to evaluate the combination of nivolumab and the PAI-1 inhibitor RS5614 for the treatment of unresectable malignant melanoma. This trial aims to assess the efficacy and safety of RS5614, and reached the target enrollment of 124 patients on October 5, 2026. The data will be analyzed after an observation period of up to three years and compiled into a clinical study report.
Key Points on the Drug and Market Background
RS5614 is a small-molecule PAI-1 inhibitor that has shown oral convenience and a favorable safety profile, and may become a new treatment option for malignant melanoma. It has been designated as an orphan drug, which is expected to provide benefits such as market exclusivity post-approval and prioritized review.
Renascience Inc.
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