Clinical TrialJul 16, 2026, 07:11 AM
Insmed Reports Positive 12-Month TPIP Data for PAH
AI Summary
INSMED Inc. announced positive 12-month safety and efficacy data from its ongoing open-label extension (OLE) study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH). The data demonstrated sustained improvement across all secondary efficacy measures, including a reduction in mortality risk status as measured by REVEAL Lite 2.0. TPIP was found to be safe and well-tolerated with no new safety signals identified, reinforcing its potential as a once-daily prostanoid for PAH patients. The company is advancing its Phase 3 PALM-PAH study.
Key Highlights
- Mean 6MWD improved by +55.7 meters for TPIP Continued group and +54.1 meters for Placebo Crossed group.
- NT-proBNP concentration reduced by approximately 60% in both TPIP Continued and Placebo Crossed groups.
- 78.3% of TPIP Continued group and 80.6% of Placebo Crossed group patients achieved WHO Functional Class I or II.
- Mean REVEAL Lite 2.0 score improved by 2.0 points (TPIP Continued) and 1.4 points (Placebo Crossed).
- Approximately 65% of all patients achieved Refined Low Risk status by REVEAL Lite 2.0.
- TPIP was well-tolerated with no newly identified safety signals; 89.0% experienced TEAEs, 7.7% discontinued.
- Four deaths occurred during the study, none considered related to TPIP treatment.
- The Phase 3 PALM-PAH study for TPIP in PAH patients is currently ongoing.
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