Core Insights - Mosliciguat is a potential first-in-class inhaled soluble Guanylate Cyclase (sGC) activator designed for once-daily administration, showing promise in treating pulmonary hypertension (PH) [1][10] - The Phase 1b ATMOS study demonstrated a mean peak reduction in pulmonary vascular resistance (PVR) of up to 38% in PH patients, indicating significant efficacy [1][4] - The upcoming Phase 2 "PHocus" study will evaluate mosliciguat in approximately 120 patients with PH associated with interstitial lung disease (PH-ILD), a condition affecting around 200,000 patients in the U.S. and Europe [1][6] Company Overview - Pulmovant is a clinical-stage biotechnology company focused on developing innovative therapies for pulmonary diseases, with mosliciguat as its lead program [10] - The company aims to provide a convenient once-daily inhaled treatment option for patients suffering from pulmonary hypertension [10] Clinical Development - The Phase 1b ATMOS study was a non-randomized, open-label trial involving 38 patients, which showed that mosliciguat led to clinically meaningful reductions in PVR [4][5] - Mosliciguat has been characterized in a robust Phase 1 program with 170 participants, demonstrating a favorable safety profile and dose-dependent increases in cGMP [2][5] - The Phase 2 PHocus study is set to begin imminently, targeting a patient population with high unmet medical needs and limited treatment options [6][8] Mechanism of Action - Mosliciguat acts as an sGC activator, independent of heme and nitric oxide (NO), which may allow it to retain efficacy in oxidative environments typical of PH [2] - The drug's mechanism may lead to increased vasodilation, reduced inflammation, and anti-fibrotic effects, differentiating it from existing therapies [2][5] Market Opportunity - PH-ILD represents a significant commercial opportunity due to its higher prevalence compared to pulmonary arterial hypertension (PAH) and the lack of approved treatment options [6][9] - The high morbidity and mortality associated with PH-ILD underscores the need for effective therapies, positioning mosliciguat as a potentially transformative treatment [8][9]
Pulmovant presents positive proof-of-concept data from the Phase 1b ATMOS study of Mosliciguat in Pulmonary Hypertension at European Respiratory Society Congress