Roivant Sciences has unveiled Pulmovant, a new company created to advance mosliciguat, an investigational soluble guanylate cyclase (sGC) activator, for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The move follows an in-licensing agreement with Bayer, granting Roivant worldwide rights to mosliciguat. The upfront payment to Bayer is $14 million, with potential development, regulatory, and commercial milestones totaling up to $280 million, plus tiered high-single-digit royalties on sales.
Pulmovant will focus on Phase II development, with the PHocus study slated to begin imminently. Initial data from this mid-stage trial are anticipated as early as the second half of 2026. Roivant estimates that positive Phase II results could potentially lead to approval with a single registrational trial.
Mosliciguat's Potential in PH-ILD
PH-ILD affects approximately 200,000 patients in the U.S. and Europe and is characterized by increased blood pressure in the lungs due to underlying lung disease. Current treatment options are limited, creating a significant unmet medical need. Matt Gline, CEO of Roivant, emphasized the potential of mosliciguat to "transform the lives of patients living with pulmonary hypertension," citing its differentiated mechanism of action for maximal impact.
Mosliciguat is designed as an inhaled therapy that activates the sGC enzyme, a key component in a signaling pathway that leads to blood vessel dilation. By activating sGC, mosliciguat aims to provide a novel treatment option for PH-ILD. Data from the Phase Ib ATMOS study, presented at the 2024 Congress of the European Respiratory Society, demonstrated that mosliciguat, at doses of 1-mg, 2-mg, and 4-mg, elicited mean-max peak reductions in pulmonary vascular resistance (PVR) from baseline of 25.9%, 38.1%, and 36.3%, respectively. Roivant considers this effect to be "clinically meaningful" and among the highest reductions observed to date.
Clinical Data and Future Development
Early-stage data from 170 healthy volunteers indicated that mosliciguat is safe and well-tolerated, with a 40-hour half-life potentially allowing for more convenient dosing schedules. According to Gline, mosliciguat offers a unique combination of potential differentiation across efficacy, safety, and convenience of administration.
The Phase II PHocus trial will enroll approximately 120 patients. The only FDA-approved treatment for PH-ILD is United Therapeutics' Tyvaso inhaled prostacyclin analogue (treprostinil).
