Roivant Reports Positive Phase 2 Trial Data for Mosliciguat, Initiates Phase 3 Study

Roivant Sciences announced positive results from its Phase 2 PHocus clinical trial for mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study successfully met its primary and secondary endpoints, demonstrating significant clinical improvements. Consequently, the company has initiated the Phase 3 PHrontier study.

Key Details

• Primary Endpoint: The trial met its primary endpoint with a statistically significant placebo-adjusted reduction in pulmonary vascular resistance (PVR) of -56.3% (p<0.0001) at Week 16.
• Secondary Endpoints: The study also met key secondary endpoints at Week 16, including a +35.2-meter placebo-adjusted improvement in the six-minute walk distance (6MWD) and a -53.2% reduction in NT-proBNP, a biomarker for cardiac strain.
• Next Steps: Roivant has initiated its global Phase 3 PHrontier clinical trial to further evaluate mosliciguat in PH-ILD, with patient enrollment currently underway.