ROIVANT (ROIV): PHASE 2 DATA GETS ATTENTION

Roivant (ROIV) reported strong Phase 2 results for mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Mosliciguat is designed to open up the blood vessels in the lungs, making it easier for blood to flow through them and reducing the workload on the heart.

By the numbers:

• 56.3% reduction in pulmonary vascular resistance vs. placebo at Week 16 (p<0.0001) — Roivant says this is the largest PVR reduction reported in a randomized controlled pulmonary hypertension trial.

• +35.2 meters improvement vs. placebo in six-minute walk distance at Week 16.

• 53.2% reduction vs. placebo in NT-proBNP, a biomarker of cardiac strain.

• At Week 24, exploratory results strengthened further: +52.7 meters in six-minute walk distance and a 75.9% reduction in NT-proBNP vs. placebo.

Mosliciguat is a once-daily inhaled sGC activator designed to target the lungs while limiting systemic exposure. Roivant estimates roughly 200,000 PH-ILD patients in the U.S. and Europe, with limited treatment options today.

There are potentially three interesting benefits:

• Better blood flow: reduces resistance in the lung's blood vessels.

• Lung-targeted: because it's inhaled, the goal is to concentrate the effect in the lungs while limiting systemic side effects.

• Potential beyond vasodilation: the sGC pathway may also have anti-inflammatory and anti-fibrotic effects, although those potential benefits still need clinical validation

Roivant has already initiated the Phase 3 PHrontier study. PHrontier is designed as a global, randomized, double-blind, placebo-controlled trial enrolling approximately 375 patients with PH-ILD. Enrollment is already underway.