Press release
Insmed Announces Topline Results from Phase 1 Study of Treprostinil Palmitil Inhalation Powder (TPIP)
--TPIP Generally Safe and Well Tolerated in Healthy Volunteers-- --TPIP Showed Substantially Lower Cmax and Longer Half-Life than Currently Available Inhaled
About this update from Insmed Incorporated
[{"type":"text","content":"--TPIP Generally Safe and Well Tolerated in Healthy Volunteers--\n --TPIP Showed Substantially Lower Cmax and Longer Half-Life than Currently Available Inhaled Treprostinil Therapy--\n --Pharmacokinetic Profile Supports Continued Development with Once-Daily Dosing--\n --Conference Call to be Held at 8:30 a.m. ET Today to Discuss Results--\n\n\nBRIDGEWATER, 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.\n\"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.\"\nThe 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 µg, and the highest dose tested in repeated dosing was 225 µg.\nThe 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 approac...