Roivant Sciences is expanding its scope to the lungs, unveiling a new subsidiary whose main asset, licensed from Bayer, offers the potential to bring patients a novel treatment for a rare type of pulmonary hypertension currently served by only one FDA-approved therapy.
The new Roivant company revealed Tuesday is named Pulmovant. Roivant, whose business model involves in-licensing drugs shelved by big pharmaceutical companies and then forming subsidiaries it calls “Vants” to advance their development, disclosed the new Vant and asset last year. But Roivant did not identify the drug or its indication until Tuesday, when it presented proof-of-concept clinical data during the European Respiratory Society Congress in Vienna, Austria.
The Pulmovant drug, mosliciguat, is being developed as a treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD) — high blood pressure in the lungs due to interstitial lung disease, a group of chronic lung disorders that lead to inflammation and scarring. The results presented are from a Phase 1b study that enrolled 38 adults with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Waltham, Massachusetts-based Pulmovant said the 1 mg, 2 mg, and 4 mg doses led to average peak percentage reductions in pulmonary vascular resistance (a measure of resistance against blood flow from the pulmonary veins) of -25.9%, -38.1%, and -36.3% respectively. These results were sustained and clinically meaningful.
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Pulmovant said a similar effect on pulmonary vascular resistance was observed in a pharmacodynamic analysis of 37 patients, including those responsive and non-responsive to inhaled nitric oxide. These results suggest mosliciguat may work across the spectrum of pulmonary hypertension, the company said. The drug is administered as a single dose taken daily via a dry powder inhaler. In the broader Phase 1 population spanning 170 healthy volunteers and pulmonary hypertension patients, Roivant said mosliciguat was safe and well tolerated with low rates of adverse effects observed.
The World Health Organization categorizes pulmonary hypertension in five groups according to disease cause and comorbidities. PH-ILD falls under Group 3 pulmonary hypertension. This disease is rare, affecting an estimated 200,000 patients in the U.S. and Europe. Standard treatment is United Therapeutics’ Tyvaso, a drug that was initially approved to treat pulmonary arterial hypertension. Tyvaso expanded its approved uses to include PH-ILD in 2021. The inhaled therapy, administered via dry powder inhalation or a nebulizer in nine to 12 puffs taken four times daily, lowers blood pressure by widening blood vessels. United Therapeutics reported more than $1.2 billion in global Tyvaso sales in 2023, a more than 41% increase over the product’s 2022 sales. The U.S. is the only market where this drug is commercialized.
Pulmovant’s mosliciguat takes a different approach to PH-ILD by activating sGC, an enzyme in a signaling pathway that’s key to maintaining homeostasis of blood vessels. While sGC stimulators can be used to treat pulmonary hypertension, these drugs require heme (an iron-containing component of hemoglobin) and nitric oxide. In pulmonary hypertension, heme is oxidized and nitric oxide levels are depleted. Pulmovant says mosliciguat works without heme and nitric oxide, allowing it to potentially retain its efficacy in a highly oxidative environment where stimulators are expected to lose efficacy. Also, unlike the multiple puffs of Tyvaso taken throughout the day, mosliciguat, administered by dry powder inhalation, requires just one puff daily. Based on Tyvaso’s $300,000 a year price, PH-ILD represents a more than $6 billion market opportunity in the U.S. and Europe, Roivant said in an investor presentation.
Without naming mosliciguat, Roivant disclosed the licensing of the drug last year in a regulatory filing that was scant on details. The company said its then unnamed new subsidiary had paid $14 million up front and agreed to pay up to $280 million more if the asset achieved milestones. It will also pay royalties on sales of a commercialized product.
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The unveiling of Pulmovant and mosliciguat comes one day after another Vant, Immunovant, announced progress in Graves’ disease, an autoimmune condition characterized by excess thyroid hormone production. Phase 2 data for batoclimab showed strong response rates and lowering of levels of an antibody associated with the disease. In addition, Immunovant said it has FDA permission to begin a Phase 3 test of another potential Graves’ disease drug, IMVT-1402.
Speaking during a Tuesday conference call, Roivant CEO Matt Gline described mosliciguat as “a compelling addition to our pipeline.” This immunology and inflammation pipeline represents more than $10 billion in potential revenue, he said.
“We think this program has certainly got multi-blockbuster potential in an indication with very high unmet patient need and not a lot of other (treatment) options,” Gline said. “It’s exactly the kind of partnership we like working on for exactly the kind of program and patient population we are excited about.”
Pulmovant plans to advance mosliciguat to a global, placebo-controlled Phase 2 study in PH-ILD. The company said the study, expected to enroll about 120 patients, will start imminently. The main goal is to measure, from baseline, the change in pulmonary vascular resistance.
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