Insmed (INSM) Earnings Call Presentation

Efficacy Results - TPIP demonstrated a statistically significant 35% placebo-adjusted reduction in pulmonary vascular resistance (PVR) from baseline at Week 16 (p<0001)[20, 33] - The study showed a 355-meter placebo-adjusted improvement in the six-minute walk distance (6MWD) from baseline[20, 36] - TPIP resulted in a statistically significant reduction in NT-proBNP concentrations, a biomarker of cardiac stress, with a placebo-adjusted reduction of 60% at Week 16 (p<0001)[38] - More patients on TPIP achieved an improvement in WHO Functional Class compared to placebo, with 30% of TPIP patients showing improvement versus 15% for placebo[40, 41] - TPIP showed a 15% increase in Cardiac Index (CI) compared to placebo at Week 16 (p=0006)[43] Safety and Tolerability - TPIP was generally well-tolerated, with 899% of participants completing the 16-week study[31] - The most common treatment-emergent adverse events (TEAEs) reported with TPIP were cough (406%) and headache (319%), consistent with the known profile of inhaled treprostinil[45] Study Design and Baseline Characteristics - The Phase 2b study was a randomized, double-blind, multi-center, placebo-controlled trial with 102 patients randomized in a 2:1 ratio (TPIP:Placebo)[25, 26] - Baseline characteristics were reasonably well-balanced across study arms, with a mean age of approximately 48 years and a majority of patients in WHO Functional Class II (approximately 66%)[30] Future Plans - The company plans to advance TPIP to Phase 3 before the end of 2025 for PH-ILD and in early 2026 for PAH[46]