Insmed's Inhaled Treprostinil Palmitil Is Safe; Healthy Volunteers Study Show

  • Insmed Incorporated (NASDAQ: INSM) has announced topline results from the Phase 1 study evaluating treprostinil palmitil inhalation powder (TPIP) in healthy volunteers. The company plans to present complete data from this study at an upcoming medical meeting.
  • The study's data demonstrated that TPIP was generally safe and well-tolerated, with a favorable pharmacokinetic profile that supports once-daily dosing.
  • The most common adverse events across all cohorts in the study were cough, dizziness, headache, and nausea. Subjects in the multiple-dose panel that incorporated an up-titration approach beginning at 112.5 µg once-daily and progressing to 225 µg once-daily reported fewer AEs than the panel dosed with 225 µg once-daily from the first dose. 
  • Overall pharmacokinetic results demonstrated that treprostinil exposure was dose-proportional. Treprostinil was detected in the plasma at 24 hours at all doses and throughout the 48-hour sampling period for the two highest doses.
  • Insmed plans to advance the development of TPIP with two studies in pulmonary arterial hypertension (PAH):
  • The first is an open-label, proof-of-mechanism study to understand the impact of TPIP on pulmonary vascular resistance (PVR) over 24 hours. Topline data expected in the second half of 2021.
  • The second study aims to investigate the effect of TPIP on PVR and 6-minute walk distance over a 16-week treatment period using an up-titration, once-daily dosing schedule. The study will start by the end of this year.
  • Insmed will host a conference call today, beginning at 8:30 a.m. ET.
  • Price Action: INSM stock closed 5.3% lower at $40.40 on Thursday.

Posted In: Phase 1 TrialBiotechNewsFDAGeneral

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