Roivant Sciences’ mosliciguat shows efficacy in pulmonary hypertension trial

Roivant’s Pulmovant company announced the presentation of data from the proof-of-concept Phase 1b ATMOS study during the ERS Congress in Vienna, Austria. ATMOS evaluated mosliciguat, a potential first-in-class, inhaled sGC activator with targeted delivery to the lungs and once-daily administration, in pulmonary hypertension, or PH, patients. ATMOS was a proof-of-concept Phase 1b trial that assessed the efficacy, safety, tolerability, and pharmacokinetics of mosliciguat following single dose inhaled administration in participants aged between 18 and 80 years. In the per-protocol set of patients, mosliciguat 1.0, 2.0 and 4.0 mg doses led to mean peak percentage reductions in PVR from baseline of -25.9%, -38.1% and -36.3%, respectively, consistently exceeding the predefined greater than or equal to -20% threshold for the primary outcome. Single dose administration via dry powder inhaler was well tolerated, with low rates of TEAEs observed. Overall, in its Phase 1 development program in 170 healthy volunteers and PH patients, mosliciguat has shown a favorable safety profile, dose-dependent increases in cGMP, and a 40-hour half-life supporting convenient once-daily dosing. Pulmovant will advance the clinical program to assess mosliciguat in its global Phase 2 PHocus study in patients with PH-ILD, a subgroup of Group 3 PH. Approximately 120 patients will be enrolled in the study, which will start imminently.