Roivant’s experimental lung disease drug mosliciguat produced a 56.3% placebo-adjusted reduction in pulmonary vascular resistance in a phase 2 trial of patients with pulmonary hypertension associated with interstitial lung disease, the highest PVR reduction reported in a randomized controlled pulmonary hypertension trial, according to a Sept. 8 news release.
Here are five things to know:
- The PHocus trial included 135 patients across 87 sites in 20 countries. Patients received once-daily inhaled mosliciguat or placebo.
- At week 16, pulmonary vascular resistance decreased 51.3% among patients receiving mosliciguat and increased 6.6% among those receiving placebo, resulting in a 56.3% placebo-adjusted reduction.
- Mosliciguat also produced a 35.2-meter placebo-adjusted improvement in six-minute walk distance at week 16.
- NT-proBNP decreased 53.2%, or 357.7 pg/mL, compared with placebo at week 16. Cough was reported in 12.1% of patients receiving mosliciguat and 18.2% of those receiving placebo.
- Pulmovant has initiated the phase 3 PHrontier trial, which is expected to enroll approximately 375 patients worldwide. Mosliciguat is a potential first-in-class, once-daily inhaled soluble guanylate cyclase activator.
