WASHINGTON (dpa-AFX) - Thursday, Insmed Incorporated (INSM) announced positive 12-Month data from the ongoing open-label extension or OLE study, evaluating treprostinil palmitil inhalation powder or TPIP in patients with pulmonary arterial hypertension.
The non-placebo-controlled trial was designed to evaluate the long-term safety, tolerability, and effectiveness of TPIP over 24 months.
The findings revealed that TPIP demonstrated sustained improvement across all efficacy endpoints and was well-tolerated with no newly identified safety signals.
At the end of 12 weeks, mean improvement from baseline for 6MWD was +55.7 meters for the TPIP Continued group compared to +54.1 meters for the Placebo Crossed group. Also, NT-proBNP concentration was reduced by approximately 60% in both groups with geometric mean ratios to baseline of 0.40 and 0.41 in TPIP Continued and Placebo Crossed, respectively.
Additionally, WHO Functional Class I or II was achieved in 78.3% of TPIP Continued group and 80.6% of Placebo Crossed group patients. Mean REVEAL Lite 2.0 score improved 2.0-points from baseline for the TPIP Continued group and 1.4-points from baseline for the Placebo Crossed group.
These 12-month findings support the commencement of PALM-PAH, a Phase 3, randomized, double-blind, placebo-controlled trial evaluating once-daily TPIP in patients with pulmonary arterial hypertension over 24 months. The primary endpoint of this study is change in 6MWD, with additional assessments of safety, tolerability, and overall efficacy.
In the pre-market hours, INSM is trading at $111.91, up 1.91 percent on the Nasdaq.
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