Roivant to Present Phase 2 Mosliciguat Results for PH-ILD

Roivant Sciences subsidiary Pulmovant is set to present topline data from the Phase 2 PHocus study evaluating mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) at the European Respiratory Society International Congress 2026. The late-breaking data release is scheduled for 12:15 CEST (6:15 a.m. ET) on Tuesday, September 8, 2026, and will be presented by Marc Humbert, MD, PhD.

The global, randomized, double-blind, placebo-controlled trial enrolled 135 adult participants to assess the safety and efficacy of the investigational therapy in this specific patient population. Pulmonary hypertension associated with interstitial lung disease is a severe condition with limited therapeutic options, making the trial's readout a closely watched milestone for the clinical-stage biotech firm.

Understanding Mosliciguat and Its Mechanism

Mosliciguat is a potential first-in-class, once-daily, inhaled soluble guanylyl cyclase (sGC) activator. The drug features a specialized mechanism of action engineered to deliver targeted pulmonary vasodilation directly to the lungs while limiting systemic side effects that typically challenge oral treatments.

Soluble guanylyl cyclase stimulators and activators work by restoring the nitric oxide-sGC-cGMP signaling pathway, which is impaired in pulmonary vascular disease. By utilizing an inhaled delivery route, Pulmovant aims to maximize local concentrations in pulmonary blood vessels while minimizing systemic blood pressure drops.

Expanding Clinical Pipeline Evaluation

Beyond the PHocus trial (NCT06635850), Pulmovant is evaluating mosliciguat in a separate mid-stage clinical program. The Phase 2 PHactor study (NCT07333183) is an open-label trial designed to assess the safety and tolerability of inhaled mosliciguat when administered in combination with inhaled treprostinil in participants with PH-ILD.

Data from the PHocus study will provide crucial clinical validation for the inhaled sGC activator platform as Roivant and Pulmovant advance their respiratory development pipeline through mid-stage trials toward potential late-stage registration studies.