Pulmovant Announces Positive Results from PHocus Study of Mosliciguat in Patients with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) and Unveils Ongoing Phase 3 PHrontier Study
Pulmovant, the Roivant (ROIV) subsidiary focused on pulmonary disease, reported positive Phase 2 PHocus results for mosliciguat in pulmonary hypertension associated with interstitial lung disease. The placebo-adjusted reduction in pulmonary vascular resistance was -56.3% at Week 16 (p<0.0001), described as the highest ever reported in any randomized controlled PH trial. Secondary endpoints also cleared: six-minute walk distance improved +35.2 meters and the cardiac-strain biomarker NT-proBNP fell 53.2% versus placebo at Week 16, with pre-specified Week 24 exploratory analyses showing benefits deepening to +52.7 meters and -75.9%.
Key figures
- Drug Name
- mosliciguat
- Phase Of Trial
- Phase 2 (PHocus); Phase 3 (PHrontier) initiated
- Ntprobnp week16
- -357.7 pg/mL (-53.2%) placebo-adjusted (p=0.0002)
- Phase2 enrollment
- 135
- Cough rate placebo
- 18.2%
- Pvr placebo week16
- +6.6%
- Six min walk week16
- +35.2 meters placebo-adjusted (p=0.0027)
- Cough rate mosliciguat
- 12.1%
- Phase2 sites countries
- 87 sites in 20 countries
- Pvr mosliciguat week16
- -51.3%
- Ph ild patient population
- up to 200,000 patients (U.S. and Europe)
- Phase3 planned enrollment
- 375
- Ntprobnp week24 exploratory
- -487.1 pg/mL (-75.9%, nominal p<0.0001)
- Pvr placebo adjusted week16
- -56.3% (p<0.0001)
- Six min walk week24 exploratory
- +52.7 meters (nominal p<0.0001)
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