Insmed Incorporated has announced data from a Phase 1 study of its treprostinil palmitil inhalation powder (TPIP) in healthy volunteers demonstrated that TPIP was generally safe and well tolerated and had a lower Cmax and longer half-life than Tyvaso. The study enrolled 42 subjects and evaluated doses as high as 225 µg for a repeated dose and 675 µg for a single dose.
The company said that based on these results, it plans to move forward with two studies of TPIP in patients with pulmonary arterial hypertension (PAH). Data from the first of those two studies is expected in the second half of this year; the second study is expected to begin in the fourth quarter. Insmed is also developing TPIP for the treatment of pulmonary hypertension associated with interstitial lung disease and idiopathic pulmonary fibrosis.
Insmed Chair and CEO Will Lewis commented, “The positive results from this Phase 1 study provide clear support for advancing TPIP to the next stage of clinical development in PAH as well as exploring its potential in other serious pulmonary disorders. These findings represent a significant step toward unlocking the full potential of prostanoid therapy. With continued development of TPIP, we look forward to evaluating whether this novel treatment candidate may offer the potential for improved tolerability, dosing convenience, and efficacy for patients with PAH.”
Chief Medical Officer Martina Flammer said, “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. 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.”
Read the Insmed press release.
