Benzinga | Feb 19, 2021 07:32AM EST

Insmed Announces Topline Results from Phase 1 Study Of Treprostinil Palmitil Inhalation Powder; Study Showed TPIP Was 'generally safe and well tolerated, with a pharmacokinetic profile that supports once-daily dosing'

BRIDGEWATER, N.J., Feb. 19, 2021 /PRNewswire/ -- Insmed Incorporated (NASDAQ:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced topline results from the Phase 1 study of treprostinil palmitil inhalation powder (TPIP) in healthy volunteers. Data from the study demonstrated that TPIP was generally safe and well tolerated, with a pharmacokinetic profile that supports once-daily dosing. A conference call will be held today, February 19, 2021, at 8:30 am ET, with Insmed management to further discuss these results and provide an update on the planned development pathway for TPIP.

"We are very pleased to share these encouraging Phase 1 results, which we believe validate several critical aspects of the TPIP profile and continue to build on the momentum of our earlier preclinical work," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "Importantly, these findings support the continued development of TPIP with once-daily dosing in a clinical trial program for patients with pulmonary arterial hypertension (PAH). This is a serious, progressive, and rare disease in which the current standard of care is limited by tolerability issues and a cumbersome dosing regimen."

The Phase 1 study of 42 healthy volunteers was designed to assess the safety, tolerability, and pharmacokinetics of TPIP in the setting of single-dose and multiple-dose administration. The highest dose tested as a single dose was 675 ?g, and the highest dose tested in repeated dosing was 225 ?g.

The study demonstrated that TPIP was generally safe and well tolerated. The most common adverse events (AEs) across all cohorts in the study were cough, dizziness, headache, and nausea. Most AEs were mild in severity and consistent in nature with those typically seen with other inhaled prostanoid therapies. There were few moderate AEs and no severe or serious AEs. 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 compared to the panel dosed with 225 ?g once-daily from the first dose.

Overall pharmacokinetic results demonstrated that treprostinil exposure (AUC and Cmax) was dose-proportional, with low to moderate inter-subject variability. Treprostinil was detected in the plasma at 24 hours at all doses and throughout the 48-hour sampling period for the two highest doses. Compared with currently available inhaled treprostinil therapy, TPIP showed substantially lower Cmax and longer half-life.

Insmed plans to present full data from this study at an upcoming medical meeting.