Roivant Sciences (NASDAQ: ROIV) reported positive top-line results from its Phase 2 PHocus trial of mosliciguat, an inhaled soluble guanylate cyclase activator being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The data, presented on September 8 at the European Respiratory Society International Congress 2026 by Professor Marc Humbert, demonstrated that mosliciguat met its primary endpoint at Week 16: a placebo-adjusted reduction in pulmonary vascular resistance of 56.3%.
Secondary endpoints also showed meaningful benefit. At Week 16, patients on mosliciguat saw a placebo-adjusted improvement in six-minute walk distance of 35.2 meters and a placebo-adjusted reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker of cardiac strain, of 357.7 pg/mL — representing a 53.2% reduction from baseline.
Exploratory pre-specified results at Week 24 showed further gains: the placebo-adjusted improvement in six-minute walk distance rose to 52.7 meters, while the reduction in NT-proBNP deepened to 75.9%.
Mosliciguat was well-tolerated, with a favorable safety profile. The incidence of cough — a relevant adverse event for an inhaled therapy — was lower in the treatment group than in placebo: 12.1% versus 18.2%.
Roivant has already initiated a Phase 3 study, PHrontier, with enrollment underway. The pivotal trial is designed to enroll approximately 375 patients worldwide.
Up to 200,000 patients across the U.S. and Europe are estimated to live with PH-ILD and have limited or no approved treatment options, underscoring the unmet medical need the company is targeting.
Mosliciguat is administered as a once-daily inhaled dose and is designed to achieve targeted pulmonary vasodilation, potentially offering a route-specific mechanism distinct from existing systemic therapies.
