Mosliciguat, being developed by the Roivant Sciences subsidiary Pulmovant, ‘significantly exceeded expectations’ in reducing pulmonary vascular resistance, according to analysts, and is progressing to a late-stage study.
Pharma collective Roivant Sciences reported that its pulmonary hypertension drug candidate mosliciguat reduced pulmonary vascular resistance in a Phase 2 trial, surpassing analysts’ expectations and lifting the company’s share price in premarket trading Tuesday.
Roivant—which just last month gained its first-ever FDA approval, for the autoimmune skin disease drug Lisraya through subsidiary Priovant—reported that mosliciguat met the primary endpoint of reducing pulmonary vascular resistance in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) by more than 56%, allowing it to move into a Phase 3 study that has already begun to enroll, according to a news release.
Analysts at Leerink Partners called the results a “blowout” in a note to investors, writing that the mid-stage trial “significantly exceeded expectations” of at least a 20% reduction. The result puts the drug candidate in a position to stand well apart from the limited options available to patients with the disease, the analysts added. The only drug specifically approved for PH-ILD is United Therapeutics’ Tyvaso, whose expanded indication was granted in 2021.
Roivant’s stock jumped more than 14% Tuesday, opening at $39.99 per share.
Mosliciguat, which Roivant purchased from Bayer in a 2024 deal worth as much as $294 million, is being developed by another of the company’s subsidiaries, Pulmovant, as part of its hub-and-spoke model of biotech businesses.
In addition to the primary endpoint that measured blood flow, patients also showed improvement in a six-minute walk and reduction of NT-proBNP, which is a biomarker of cardiac strain, as well as lower cough incidence than other treatments for the disease.
“PH-ILD is a disease as bad as some forms of cancer, with a median survival of just 1.5-2 years despite best-available standard of care,” Mayukh Sukhatme, president and chief investment officer at Roivant, said in a release, noting that the result “puts mosliciguat in a league of its own” on the available endpoints. “It is a terrific example of the Roivant model working as planned: finding high-potential molecules and going after diseases where the patient needs are enormous and where the drug can truly shine.”
