Insmed's Pulmonary Hypertension Drug Data Exceeded Even Bullish Outlook, Analysts Boost Price Forecast

Insmed Incorporated (NASDAQ:INSM) on Tuesday released topline results from its Phase 2b study of treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension.

The study met its primary endpoint and all secondary efficacy endpoints. For the primary endpoint, the placebo-adjusted reduction from baseline in pulmonary vascular resistance (PVR) was 35%, with a Least Squares (LS) mean ratio of 0.65.

The placebo-adjusted improvement in six-minute walk distance (6MWD) was 35.5 meters for the secondary efficacy endpoints.

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The placebo-adjusted reduction from baseline in N-terminal pro-b-type natriuretic peptide (NT-proBNP) concentrations, a biomarker for cardiac stress, was 60%, with an LS mean ratio of 0.40.

These results demonstrate the durability of TPIP’s therapeutic effect as a once-daily therapy based on efficacy evaluated approximately 24 hours after administering therapy.

Insmed will engage with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 trial design for PAH.

Insmed plans to initiate a Phase 3 trial in patients with pulmonary hypertension associated with interstitial ...