Roivant Sciences has debuted its newest spinout venture Pulmovant, which will focus on the development of the investigational soluble guanylate cyclase activator mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Under an in-license agreement worth up to $294 million, Roivant has gained exclusive worldwide rights from Bayer to develop and commercialize mosliciguat, a potential first-in-class inhaled therapy.
The deal includes an upfront payment of $14 million and the promise of up to $280 million in future development, regulatory and commercial milestones. Bayer will also be eligible for tiered high-single digit royalties on mosliciguat’s sales.
Pulmovant will advance mosliciguat through Phase II development, with the mid-stage PHocus study set to “begin imminently,” according to an investor presentation. Initial data from PHocus could come as early as the second half of 2026.
If mosliciguat’s Phase II findings are positive, Roivant estimates that a single registrational trial could be enough to pave the way for its approval.
“We believe mosliciguat can transform the lives of patients living with pulmonary hypertension,” Roivant CEO Matt Gline said in a statement, noting mosliciguat’s “differentiated mechanism of action” can lead to “maximal impact on PH-ILD patients.”
Designed to be an inhaled therapy, mosliciguat is an activator of the soluble guanylate cyclase (sGC) enzyme, which is central to a signaling cascade that culminates in the widening of blood vessels. By activating sGC, mosliciguat offers a new and potentially best-in-category treatment option for PH-ILD, a disease that affects around 200,000 patients in the U.S. and Europe, with little or no effective treatments, according to Roivant.
Data from the Phase Ib ATMOS study, presented at the 2024 Congress of the European Respiratory Society in Vienna, showed that at 1-mg, 2-mg and 4-mg doses, mosliciguat elicited a mean-max peak reduction of 25.9%, 38.1% and 36.3% in pulmonary vascular resistance from baseline, respectively. According to Roivant, this effect was “clinically meaningful” and is “one of the highest reductions seen” to date.
Early-stage data from 170 healthy volunteers also showed that mosliciguat is safe and well-tolerated, while its 40-hour half-life can also open more practical dosing schedules. “Mosliciguat has the incredibly rare advantage of potential differentiation across three separate key areas—efficacy, safety, and convenience in administration,” Gline said.
Tuesday’s announcement comes after Roivant in October 2023 scored a $7.1-billion windfall from the sale of its inflammatory bowel disease candidate to Roche.