Roivant's new 'vant' emerges to advance Bayer lung drug

Roivant's latest biotech company launch – Pulmovant – has made its debut with a plan to develop a respiratory drug licensed from Bayer in a deal worth up to $294 million.

Pulmovant is tasked with taking forward mosliciguat, an inhaled soluble guanylate cyclase (sGC) activator, which is being developed to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD), a disease with limited treatment options.

The company introduced Pulmovant, which has been running under the radar to date, as phase 1b trial results with mosliciguat were presented at the European Respiratory Society (ERS) congress in Vienna.

The results of the ATMOS study showed that a single dose of the drug administered using a dry powder inhaler (DPI) led to a sustained reduction in pulmonary vascular resistance (PVR), a surrogate marker for efficacy in PH-ILD.

At the moment, the only FDA-approved treatment for PH-ILD is United Therapeutics' Tyvaso inhaled prostacyclin analogue (treprostinil), which is delivered either using a nebuliser or as a DPI four times a day. Tyvaso is United's biggest product, with sales of more than $770 million in the first half of the year, all from the US market. It is not sold overseas.

Other drugs are used off-label to treat the disease in some cases - if there is underlying fibrosis, for example - and the FDA is currently reviewing a DPI formulation of treprostinil developed by Liquidia that is also given four times a day.

Roivant has in-licensed global rights to mosliciguat from Bayer for an upfront payment of $14 million and the promise of up to $280 million in future development, regulatory, and commercial milestones. Pulmovant is now preparing to start a phase 2 trial of the drug, called PHocus, which will enrol around 120 patients and should generate results in 2026.

Roivant's chief executive, Matt Gline, said that the PVR results in ATMOS were particularly impressive – one of the highest reductions seen in trials to date in this setting – and suggest mosliciguat "has the incredibly rare advantage of potential differentiation across three separate key areas: efficacy, safety, and convenience in administration."

PH-ILD affects around 200,000 patients in the US and Europe, a prevalence that is "meaningfully greater" than pulmonary arterial hypertension (PAH), a related disorder, said Roivant. The PAH market is valued at several billion dollars a year and, according to some estimates, affects up to 70 million people worldwide.

Gline said on a conference call that the mosliciguat deal has "multi-blockbuster potential."