Insmed's Inhaled Treprostinil Palmitil Is Safe; Healthy Volunteers Study Show - Insmed (NASDAQ:INSM)

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.

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