TOKYO, Apr 10 (Pulse News Wire) – Renascience Inc. (4889.T) reported interim results from its Phase II trial of PAI-1 inhibitor RS101 for systemic sclerosis-associated interstitial lung disease (SSc-ILD).
The trial, conducted across 12 facilities including Tohoku University, was completed on November 25, 2025, with 50 patients enrolled and treated for 48 weeks. The primary endpoint, a 48-week change in forced vital capacity (%FVC), did not show significant improvement compared to the placebo group. However, additional analyses suggested a trend toward skin hardening improvement measured by mRSS scores.
Specifically, piecewise linear mixed model analysis indicated a more pronounced effect during the middle phase of treatment (weeks 12 to 36). Regarding safety, the drug demonstrated overall tolerability without major deviations from known side effects. One case of cerebral hemorrhage was observed but attributed cautiously due to pre-existing hypertension in the patient.
Further data will be compiled into a comprehensive report, and Renascience stated it would disclose any future developments impacting fiscal 2027 earnings promptly.
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