Pulmovant, a clinical-stage biotech and Roivant (NASDAQ: ROIV ) company, on Tuesday shared topline data from its Phase 2 PHocus clinical trial evaluating mosliciguat for pulmonary hypertension associated with interstitial lung disease (PH-ILD).
PH-ILD occurs when scarring and inflammation in the lungs restrict blood flow through the pulmonary arteries, raising blood pressure within the lungs.
Presented at the European Respiratory Society International Congress 2026, the data highlight meaningful clinical progress in PH-ILD patients.
PHocus Trial Achieves Primary And Secondary Targets
At Week 16, the study met its primary endpoint by demonstrating a statistically significant, placebo-adjusted pulmonary vascular resistance reduction of 56.3%, derived from a 51.3% drop in mosliciguat patients versus a 6.6% increase in placebo.
The company called it the highest ever reported PVR reduction in any randomized controlled PH trial.
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2 min read Read this articleMosliciguat also met its secondary endpoints, delivering a placebo-adjusted 35.2-meter improvement in six-minute walk distance alongside a 357.7 pg/mL drop in NT-proBNP, a key cardiac strain biomarker.
Exploratory Results Display Strengthened Efficacy
A pre-specified exploratory analysis revealed expanding therapeutic effects through Week 24.
Placebo-adjusted walk distance improvements expanded to 52.7 meters, while NT-proBNP reductions reached 487.1 pg/mL, representing a 75.9% decline.
TrendingMosliciguat was well tolerated, with cough incidence reaching just 12.1% in the treatment arm compared to 18.2% in placebo, successfully avoiding a common issue seen with inhaled prostacyclins.
Novel Mechanism Drives Phase 3 Program
Mosliciguat operates as a potential first-in-class, once-daily inhaled sGC activator that triggers sGC independently of nitric oxide or heme status.
The mechanism provides targeted pulmonary vasodilation with limited systemic side effects while potentially offering anti-fibrotic, anti-inflammatory, and anti-apoptotic benefits.
With up to 200,000 Group 3 PH-ILD patients living across the U.S. and Europe, Roivant has already initiated patient enrollment for its Phase 3 PHrontier trial.
ROIV Stock Price Activity: Roivant Sciences shares were up 17.69% at $41.11 during premarket trading on Tuesday, according to Benzinga Pro data .
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