Insmed Announces Positive Topline Results from Phase 2b Study of Treprostinil Palmitil Inhalation Powder (TPIP) as Once-Daily Therapy in Patients with Pulmonary Arterial Hypertension

Core Insights - Insmed announced positive topline results from its Phase 2b study of treprostinil palmitil inhalation powder (TPIP) for pulmonary arterial hypertension (PAH), meeting primary and all secondary efficacy endpoints [1][2][3] - The study demonstrated a 35% placebo-adjusted reduction in pulmonary vascular resistance (PVR) and a 35.5-meter improvement in six-minute walk distance (6MWD) [5][6] - Insmed plans to engage with the FDA for Phase 3 trial design, with trials for pulmonary hypertension associated with interstitial lung disease (PH-ILD) expected to start before the end of 2025 and for PAH in early 2026 [2][3] Study Results - The Phase 2b study was randomized, double-blind, and placebo-controlled, involving 102 patients across 44 sites [3][12] - Patients were titrated from an initial dose of 80 µg to a maximum of 640 µg once daily, with 75% reaching the maximum dose [3][12] - Treatment-emergent adverse events (TEAEs) occurred in 88.4% of TPIP patients, with serious TEAEs in 7.2% and severe TEAEs in 5.8% [4][6] Future Plans - Insmed will host an investor call to discuss the Phase 2b study results and future plans [8][9] - A long-term open-label extension study will evaluate TPIP at doses up to 1,280 µg once daily, with 95% of Phase 2b completers enrolling [7][12] - Detailed results from the Phase 2b study and the open-label extension will be presented at future medical meetings [7]