Roivant reports 56% PH-ILD trial improvement

• Roivant reported Phase 2 PHocus results showing mosliciguat reduced pulmonary vascular resistance (PVR) by 56.3% versus placebo in patients with pulmonary hypertension associated with interstitial lung disease.
• The trial also showed improvements in six-minute walk distance and NT-proBNP, a marker of cardiac strain, at Week 16.
• Roivant has started the Phase 3 PHrontier trial to further evaluate mosliciguat in PH-ILD patients.

Roivant (NASDAQ:ROIV) reported Phase 2 PHocus trial results showing mosliciguat reduced pulmonary vascular resistance by 56.3% versus placebo in patients with pulmonary hypertension associated with interstitial lung disease.

The randomized clinical trial met its primary endpoint at Week 16, with mosliciguat producing a placebo-adjusted PVR reduction of -56.3%, compared with a 6.6% increase in the placebo group.

The study also met secondary endpoints, showing a placebo-adjusted improvement in six-minute walk distance of 35.2 meters and a reduction in NT-proBNP of 357.7 pg/mL at Week 16, while exploratory Week 24 data showed further improvements.

Roivant reported that mosliciguat was generally well tolerated, with cough occurring in 12.1% of patients receiving treatment compared with 18.2% of patients receiving placebo.

Roivant’s subsidiary Pulmovant is developing mosliciguat as a potential once-daily inhaled sGC activator for PH-ILD, and the company has initiated the Phase 3 PHrontier trial.