Roivant Sciences Ltd. (ROIV) has taken a significant step forward in the treatment of pulmonary hypertension (PH) with the creation of Pulmovant. This subsidiary has in-licensed exclusive worldwide rights to develop and commercialize mosliciguat from Bayer AG (BAYRY). This deal involved an upfront cash payment of approximately $14 million to Bayer, with the potential for an additional $280 million in future development, regulatory, commercial milestone payments, and tiered high-single-digit sales-based royalties.
Mosliciguat is an inhaled, once-daily sGC activator that utilizes a dry powder inhaler for targeted delivery to the lungs. Early data presented at the European Respiratory Society Congress from the proof-of-concept Phase 1b ATMOS study showcased promising results for this novel therapy.
The ATMOS Phase 1b trial, involving 38 patients with PH aged 18 to 80, assessed the efficacy, safety, tolerability, and pharmacokinetics of mosliciguat. In the per-protocol set of patients (N=20), mosliciguat doses of 1.0, 2.0, and 4.0 mg led to mean-max peak reductions in pulmonary vascular resistance (PVR) from baseline of -25.9%, -38.1%, and -36.3%, respectively. These reductions are considered “clinically meaningful” by Pulmovant, representing some of the highest reductions observed in PH trials to date.
Mosliciguat stands out from other inhaled PH therapies by requiring only one inhalation per day, unlike other treatments which demand multiple inhalations throughout the day. “We are impressed with the data generated so far, particularly the PVR results, and we believe its differentiated mechanism as an sGC activator can have maximal impact on PH-ILD patients, a large population with severe disease, high morbidity and mortality, and few treatment options,” said Matt Gline, Roivant’s CEO.
The positive effects on PVR were also observed in the pharmacodynamic analysis set (N=37), encompassing both responsive and non-responsive participants to inhaled nitric oxide (NO). Pulmovant will further advance the clinical program with the global Phase 2 PHocus study, focusing on patients with PH-ILD, a subgroup of Group 3 PH. This study, slated to begin imminently, will enroll approximately 120 patients.
The potential of mosliciguat has sparked significant interest in the market. However, it’s important to remember that early trial results are just one step in the long process of drug development. Further studies are crucial to confirm the safety and efficacy of mosliciguat before it can be made available to patients.
