Insmed says TPIP open-label extension shows sustained 12-month gains in PAH patients

Data support the Phase 3 PALM-PAH trial, a 24-week placebo-controlled study with 6-minute walk distance as the primary endpoint.

Insmed reported positive 12-month open-label extension data for once-daily treprostinil palmitil inhalation powder in pulmonary arterial hypertension.

• 6-minute walk distance improved 55.7 meters in the TPIP-continued group, 54.1 meters in the placebo-crossed group.
• NT-proBNP fell about 60% in both groups; REVEAL Lite 2.0 score improved 2.0 points and 1.4 points, respectively.
• Safety through month 12 showed no new signals at doses up to 1,280 µg; 7.7% discontinued due to adverse events; four deaths were not treatment-related.