Pulmovant has announced that the Phase 2 PHocus clinical trial of its inhaled dry powder mosliciguat in patients with pulmonary hypertension due to interstitial lung disease (PH-ILD) met its primary endpoint, demonstrating a significant reduction in pulmonary vascular resistance (PVR) at Week 16. The company says that the -56.3% placebo-adjusted reduction in PVR is the largest such reduction ever demonstrated in any randomized controlled trial in pulmonary hypertension.
According to Pulmovant, the trial also met its secondary endpoints, including a placebo-adjusted improvement in six-minute walk distance (6MWD) of over 35 meters at Week 16, and the improvement in 6MWD increased to almost 53 meters at Week 24. The company notes that the dry powder mosliciguat was well tolerated, with only about 12% of patients receiving mosliciguat experiencing cough compared to about 18% of patients who received an inhaled dry powder placebo.
Pulmovant parent company Roivant announced in September 2024 that it had licensed mosliciguat from Bayer and that Pulmovant would develop the DPI for the treatment of PH-ILD, and the PHocus trial was initiated the following month. Pulmovant announced the completion of enrollment in the PHocus study earlier this year. In the current announcement, the company said that it has initiated the Phase 3 PHrontier study of mosliciguat in patients with PH-ILD.
Pulmovant CEO Drew Fromkin commented, “Our robust Phase 2 PHocus study results, in conjunction with mosliciguat’s inhaled, once-a-day administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD. Today, the treatment landscape is sparse, primarily consisting of formulations of inhaled treprostinil and their associated limitations, and off-label use of PDE5 inhibitors. With these results, mosliciguat has demonstrated that it may address many of these treatment gaps.”
Read the Pulmovant press release
