Insmed reports 12-month OLE data for TPIP in PAH patients

Insmed Incorporated (Nasdaq: INSM) released 12-month data from an ongoing open-label extension (OLE) study evaluating treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH), according to a company statement issued July 16, 2026.

The 24-month OLE study enrolled 91 patients across 45 global sites. At month 12, patients in the TPIP Continued group (N=60) showed a mean improvement in six-minute walk distance of +55.7 meters from baseline, while the Placebo Crossed group (N=31) showed +54.1 meters. NT-proBNP concentration was reduced by approximately 60% in both groups. WHO Functional Class I or II was achieved in 78.3% of the TPIP Continued group and 80.6% of the Placebo Crossed group.

Mean REVEAL Lite 2.0 scores improved by 2.0 points from baseline in the TPIP Continued group and 1.4 points in the Placebo Crossed group. Approximately 65% of all patients achieved Refined Low Risk status, associated with an estimated mortality risk of less than 5% at three years.

On safety, treatment-emergent adverse events (TEAEs) were reported in 89.0% of patients. Serious TEAEs occurred in 18.7% of patients and severe TEAEs in 16.5%. TEAEs leading to discontinuation were observed in 7.7% of patients. Four deaths occurred; none were considered related to TPIP. The most common TEAEs included headache (28.6%), cough (15.4%), and nasopharyngitis (14.3%). Doses up to 1,280 µg once daily were permitted.

Insmed said the OLE findings support continued development of TPIP, including the recently initiated PALM-PAH Phase 3 trial, a randomized, double-blind, placebo-controlled study evaluating once-daily TPIP over 24 weeks. The primary endpoint of PALM-PAH is change in six-minute walk distance.

TPIP remains an investigational drug product and has not been approved for any indication in any jurisdiction. Topline results from the Phase 2b study were previously reported in June 2025.

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