Roivant Launches 'Vant' for Bayer's Pulmonary Hypertension Drug

Roivant Sciences has entered into an in-license agreement with Bayer, potentially worth up to $294 million, to obtain exclusive worldwide rights to develop and commercialize mosliciguat. Mosliciguat is a promising inhaled activator of soluble Guanylate Cyclase (sGC), which could become a pioneering treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD).

As part of this strategic move, Roivant has launched a new subsidiary named Pulmovant. Pulmovant's primary focus will be advancing the development of mosliciguat. In conjunction with this announcement, Roivant confirmed that it paid Bayer $14 million upfront with the potential for an additional $280 million based on future development, regulatory, and commercial milestones. Bayer will also receive tiered royalties on mosliciguat sales.

Pulmovant is set to push mosliciguat into Phase II clinical trials shortly, with the mid-stage PHocus study expected to start soon. Preliminary data from this study may be available by the latter half of 2026. Should the Phase II results prove favorable, Roivant believes that a single registrational trial might be sufficient for the drug’s approval.

Roivant's CEO, Matt Gline, expressed optimism about mosliciguat's potential. He emphasized that the drug could significantly impact the lives of patients suffering from pulmonary hypertension due to its unique mechanism of action. This mechanism involves activating the sGC enzyme, which is key to a complex signaling pathway that ultimately leads to the dilation of blood vessels. Such an approach is expected to offer a novel and highly effective treatment option for PH-ILD, a condition that currently lacks satisfactory treatments and affects around 200,000 individuals in the U.S. and Europe.

Initial findings from the Phase Ib ATMOS study, which were presented at the 2024 Congress of the European Respiratory Society in Vienna, demonstrated promising results. At dosages of 1 mg, 2 mg, and 4 mg, mosliciguat induced a significant reduction in pulmonary vascular resistance by 25.9%, 38.1%, and 36.3% from baseline, respectively. Roivant highlighted these reductions as clinically meaningful, marking some of the most substantial improvements observed to date.

Further early-stage research involving 170 healthy volunteers indicated that mosliciguat is safe and well-tolerated. Its 40-hour half-life also suggests the possibility of more flexible dosing schedules. Gline pointed out that mosliciguat holds the rare potential to stand out in three critical areas: efficacy, safety, and convenience in administration.

This announcement follows a significant financial boost for Roivant in October 2023, when the company secured $7.1 billion from selling its inflammatory bowel disease candidate RVT-3101 to Roche. The candidate, an investigational anti-TL1A antibody developed by Televant Holdings, was aimed at treating conditions like ulcerative colitis and Crohn’s disease. The transaction was finalized in December 2023.

In summary, Roivant Sciences’ acquisition of mosliciguat from Bayer, and the establishment of Pulmovant, mark a significant step forward in addressing the unmet medical needs of PH-ILD patients. The encouraging early data and strategic planning indicate a promising future for this potential new therapy.