Insmed advances four Phase 3 studies for inhaled lung-disease therapy

Insmed has started three Phase 3 studies of once-daily treprostinil palmitil inhalation powder, known as TPIP, in pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, and progressive pulmonary fibrosis. The fourth study, for idiopathic pulmonary fibrosis, is due to start in the first half of 2027. Insmed targets enrollment exceeding 2,000 patients across the four-study program, with primary measures including 6-minute walk distance or forced vital capacity.

The program expands TPIP's potential clinical use across four progressive pulmonary diseases, but the therapy remains investigational and is not approved for any indication. Investors now have four pivotal studies to monitor, with the final study not scheduled to start until the first half of 2027.

  • 1Three studies, PALM-PAH, PALM-ILD and PALM-PPF, have begun, while PALM-IPF is scheduled for the first half of 2027.
  • 2Insmed's four studies are intended to enroll more than 2,000 patients.
  • 3PALM-PAH and PALM-ILD each run for 24 weeks and use change from baseline in 6-minute walk distance at Week 24 as the primary endpoint.
  • 4PALM-PPF and PALM-IPF run for 52 to 104 weeks and use change from baseline in absolute forced vital capacity at Week 52 as the primary endpoint.
  • 5TPIP has not been approved for any indication in any jurisdiction.

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