Roivant has revealed that its Pulmovant subsidiary is developing inhaled dry powder mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), and Pulmovant presented a poster with data from the Phase 1b ATMOS study of mosliciguat at the 2024 ERS Congress. Roivant says that it paid approximately $14 million up front plus up to $280 million in milestones and royalties to license mosliciguat (BAY1237592) from Bayer.
According to Roivant, the company created Pulmovant specifically to license, develop, and commercialize the DPI. In 2018, Roivant said that it had created a new “vant” called Pulmovant to develop a cromolyn sodium inhalation solution licensed from Patara Pharma. Roivant says that Pulmovant has already initiated the Phase 2 PHocus study of mosliciguat, which is expected to enroll approximately 120 PH-ILD patients.
The announcement highlights the convenience of the dry powder formulation: “Mosliciguat is unique among inhaled PH therapies, requiring just one puff once per day to deliver its potential best-in-category PVR reductions – all currently approved therapies require multiple puffs, multiple times per day. Mosliciguat is formulated for delivery via DPI, providing greater convenience to patients compared to nebulizers required for many existing inhaled PH therapies.”
Roivant CEO Matt Gline commented, “We believe mosliciguat can transform the lives of patients living with pulmonary hypertension, and I am excited to announce this potential first-in-class and best-in-category therapy. Mosliciguat has the incredibly rare advantage of potential differentiation across three separate key areas: efficacy, safety, and convenience in administration. We are impressed with the data generated so far, particularly the PVR results, and we believe its differentiated mechanism as an sGC activator can have maximal impact on PH-ILD patients, a large population with severe disease, high morbidity and mortality, and few treatment options.”
Read the Roivant press release.
