Roivant’s experimental lung drug meets goals in mid-stage study

• Mosliciguat reduced pressure and resistance in lung blood vessels by 56.3% compared to placebo after 16 weeks in a 135-patient trial across 87 sites in 20 countries
• Secondary endpoints showed patients walked 35.2 meters farther at 16 weeks and 52.7 meters farther at 24 weeks compared to placebo, with a 53.2% reduction in heart strain markers
• The drug addresses pulmonary hypertension in interstitial lung disease patients, a condition where lung scarring forces the heart to work harder, currently treated with inhaled treprostinil or off-label PDE5 inhibitors

Summary: Roivant's Experimental Lung Drug Meets Mid-Stage Trial Goals

Key Development:

Roivant Sciences announced Tuesday that its experimental drug mosliciguat successfully met primary endpoints in a mid-stage clinical trial for pulmonary hypertension associated with interstitial lung disease (ILD-PH).

Clinical Results:

• Primary endpoint: 56.3% reduction in lung blood vessel pressure and resistance versus placebo after 16 weeks
• Six-minute walk test: Patients walked 35.2 meters farther at Week 16, improving to 52.7 meters by Week 24
• Heart strain biomarker: Decreased 53.2% compared to placebo at Week 16, with continued improvement through Week 24
• Trial enrolled 135 patients across 87 sites in 20 countries

Market Context:

The positive results follow Roivant's recent FDA approval for Lisraya, a skin and muscle disease treatment, as the company expands its late-stage pipeline. Current treatment options for ILD-PH include United Therapeutics' Tyvaso products, Liquidia's Yutrepia, and off-label use of PDE5 inhibitors like Viagra and Cialis.

Disease Background:

Pulmonary hypertension in ILD patients occurs when lung scarring damages blood vessels, forcing the heart to work harder to pump blood—a serious condition with limited treatment options.

Next Steps:

Roivant has already initiated a late-stage study planning to enroll approximately 375 patients worldwide.

Market Implications:

If approved, mosliciguat could address a significant unmet medical need in a growing market, potentially competing with established therapies from United Therapeutics, Liquidia, Viatris, and Eli Lilly.