Roivant’s pulmonary hypertension drug posts positive Phase 2 results
Mosliciguat reduced pulmonary vascular resistance and improved walking distance in the PHocus trial, but the treatment still faces a Phase 3 test.
Roivant Sciences shares rose 18% on 8 September after the company reported positive topline results from the Phase 2 PHocus trial of mosliciguat, an experimental inhaled treatment for pulmonary hypertension associated with interstitial lung disease.
The trial reportedly showed a 56.3% placebo-adjusted reduction in pulmonary vascular resistance. Six-minute walk distance also improved by 35.2 metres versus placebo at Week 16.
The results exceed a 20% pulmonary vascular-resistance reduction benchmark previously identified by Leerink Partners analyst David Risinger. Risinger has estimated that mosliciguat could eventually generate more than US$10 billion in annual sales across multiple indications, subject to approval and commercial uptake.
Roivant describes mosliciguat as a potential first-in-class inhaled activator. The company has already secured US approval for Lisraya, while the new candidate could add another commercial asset if its clinical benefits are confirmed.
The findings remain preliminary. The supplied results do not include the trial size, statistical significance, confidence intervals or adverse-event data, and mosliciguat must reproduce its reported benefits in the Phase 3 PHrontier trial. The share-price rally is not evidence of clinical efficacy, while adoption, pricing, reimbursement and competition remain uncertain.
