Roivant 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
Roivant's Phase 2 PHocus trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease met its primary endpoint with a -56.3% placebo-adjusted reduction in pulmonary vascular resistance at Week 16 (p<0.0001), which the company says is the largest PVR reduction ever reported in a randomized controlled PH trial. Secondary endpoints were also met: a +35.2-meter placebo-adjusted gain in six-minute walk distance and a -53.2% placebo-adjusted NT-proBNP reduction at Week 16, strengthening by Week 24 to +52.7 meters and -75.9% in exploratory analyses.
Key figures
- Drug Name
- mosliciguat
- Phase Of Trial
- Phase 2 (PHocus) completed; Phase 3 (PHrontier) initiated
- Phocus enrollment
- 135
- Cough rate placebo
- 18.2%
- Cough rate mosliciguat
- 12.1%
- Phocus sites countries
- 87 sites in 20 countries
- Phrontier planned enrollment
- 375
- Week24 nt probnp exploratory
- -75.9% (-487.1 pg/mL, nominal p<0.0001)
- Pvr placebo adjusted reduction
- -56.3% at Week 16 (p<0.0001)
- Ph ild patient population us eu
- up to 200,000
- Week24 six min walk exploratory
- +52.7 meters (nominal p<0.0001)
- Six min walk placebo adjusted gain
- +35.2 meters at Week 16 (p=0.0027)
- Nt probnp placebo adjusted reduction
- -53.2% (-357.7 pg/mL) at Week 16 (p=0.0002)
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