Benzinga | Feb 19, 2021 08:38AM EST

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 ?g once-daily and progressing to 225 ?g once-daily reported fewer AEs than the panel dosed with 225 ?g 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.