Pulmovant Completes Enrollment in Phase 2 Trial of Mosliciguat for Pulmonary Hypertension Associated with Interstitial Lung Disease
核心洞察
Pulmovant (搜索) has completed enrollment in its Phase 2 PHocus trial of mosliciguat for pulmonary hypertension associated with interstitial lung disease (搜索) (PH-ILD) in under 12 months.
Mosliciguat is a potential first-in-class, once-daily inhaled sGC (搜索) activator that demonstrated up to 38% reduction in pulmonary vascular resistance in Phase 1b studies.
The trial addresses a significant unmet medical need for up to 200,000 patients across the U.S. and Europe living with PH-ILD who have limited treatment options.
Pulmovant (搜索), a clinical-stage biotechnology company and subsidiary of Roivant (搜索) Sciences, has completed enrollment in its Phase 2 PHocus clinical trial evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (搜索) (PH-ILD). The company achieved this milestone in under 12 months from first patient dosed, representing a rapid enrollment pace for this rare and progressive condition.
Addressing Critical Unmet Medical Need
PH-ILD affects up to 200,000 patients across the U.S. and Europe, representing a subset of Group 3 pulmonary hypertension (搜索) that arises from lung diseases. These patients currently have limited or no approved treatment options, creating a significant therapeutic gap in care. Pulmonary hypertension is characterized by high blood pressure in the blood vessels of the lungs, forcing the heart to work harder and leading to symptoms including shortness of breath, fatigue, chest pain, and dizziness.
"Completing enrollment of the PHocus study in less than one year from first patient dosed underscores the strong demand for new therapeutic options for patients suffering from PH-ILD," said Drew Fromkin, Chief Executive Officer of Pulmovant (搜索). "People living with PH-ILD have limited treatment options as current therapies are often poorly tolerated and require multiple doses per day, contributing to a high treatment burden."
Novel Mechanism of Action Shows Promise
Mosliciguat represents a potential first-in-class, once-daily, inhaled soluble guanylate cyclase (搜索) (sGC (搜索)) activator with a differentiated mechanism of action. The drug targets sGC, a key enzyme in the nitric oxide/cyclic guanosine monophosphate signaling pathway that catalyzes cGMP production. Elevated cGMP levels promote vasodilation, contribute to anti-fibrotic effects, reduce inflammation and apoptosis, and reverse vascular remodeling.
Unlike sGC (搜索) stimulators that require reduced heme and nitric oxide to function, mosliciguat is an sGC activator believed to work independently of heme and NO. This mechanism may provide advantages in diseased tissue where nitric oxide bioavailability is compromised.
Strong Phase 1b Results Support Development
In the Phase 1b ATMOS study, a single dose of inhaled mosliciguat in pulmonary hypertension (搜索) patients was well tolerated and demonstrated clinically meaningful efficacy. The treatment led to a mean peak reduction in pulmonary vascular resistance of up to 38%, representing one of the highest reductions observed in pulmonary hypertension trials to date.
Phase 2 Trial Design and Timeline
The Phase 2 PHocus clinical study (NCT06635850) is a randomized, double-blind, placebo-controlled, global trial assessing the safety and efficacy of mosliciguat in approximately 120 adult participants with PH-ILD. Pulmovant (搜索) remains on track to report topline data from the study in the second half of calendar year 2026.
Additionally, mosliciguat is being evaluated in the Phase 2 PHactor clinical study (NCT07333183), an open-label trial examining the tolerability and safety of inhaled mosliciguat in combination with inhaled treprostinil in participants with PH-ILD.
Broader Pipeline Context
Mosliciguat's development occurs within Roivant (搜索)'s broader pipeline, which includes brepocitinib for dermatomyositis and other inflammatory conditions, and monoclonal antibodies IMVT-1402 and batoclimab targeting FcRn (搜索) for autoimmune indications. The company's approach of creating specialized subsidiaries allows focused development of targeted therapies for specific patient populations.
The rapid enrollment achievement reflects both the urgent clinical need and the potential of mosliciguat's differentiated approach to treating pulmonary hypertension associated with interstitial lung disease (搜索).