Mosliciguat Phase 2 trial meets primary endpoint in Pulmonary Hypertension Associated with Interstitial Lung Disease (Roivant Sciences)

Trial details

Drug

MosliciguatType Drug · Route inhaled

Treats

Studied as a treatment for pulmonary hypertension.Conditions Pulmonary Hypertension, Interstitial Lung Disease, Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis

Patients

135 patients (actual enrollment)3 arms · 85 sites in 20 countries

Phase

Phase 2

Design

Randomized, quadruple-blind, placebo-controlled, parallel-group

Primary endpoint

Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) (Baseline, Week 16)

Key secondary endpoints

• Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT)
• Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)

Result

Met endpointTogether, these results represent a clinically meaningful advancement in this field and highlight the potential of mosliciguat to address a longstanding gap in care for a patient population with high mortality and limited treatment options.” The PHocus study met its primary endpoint, demonstrating a clinically meaningful and statistically significant placebo-adjusted reduction in PVR of -56.3%…p-value p<0.0001Figures as reported by the sponsor or registry; not calculated by DrugTrials.org.

Safety

Mosliciguat was observed to be well tolerated, with a favorable safety profile and adverse events consistent with the underlying PH-ILD condition.

Sponsor

Roivant Sciences Nasdaq: ROIV

Dates

Study start Oct 29, 2024Primary completion May 26, 2026Announced Sep 8, 2026, 9:15 AM ET (SEC 8-K filing time)

Trial ID

NCT06635850 ClinicalTrials.gov