On Tuesday, shares of Insmed Incorporated (NASDAQ: INSM) increased significantly, closing at $90.93 after increasing 28.65%. The stock-price spike was sparked by the disclosure of encouraging results from a crucial Phase 2b clinical study evaluating its novel treatment for pulmonary arterial hypertension (PAH).
Positive Results from the TPIP Study
A randomized, double-blind, placebo-controlled Phase 2b research evaluating the safety and effectiveness of treprostinil palmitil inhalation powder (TPIP), given once daily to patients with PAH, has shown positive topline findings, according to Insmed (INSM). The primary objective of the trial, a 35% placebo-adjusted reduction in pulmonary vascular resistance (PVR), was achieved with a Least Squares mean ratio of 0.65.
Top 5 EV Tech Stocks to Buy for 2023
The electric vehicle boom is accelerating – and fast. According a new report published by BloombergNEF, annual spending on passenger EVs hit $388 billion in 2022, up 53% from the year before. Like we said, the boom is accelerating – and the time to buy EV-related tech stocks is now. Get our free report, "Top 5 EV Tech Stocks to Buy for 2023".
Click Here to Download the FREE Report.
Sponsored
Additionally, every secondary efficacy endpoint was satisfied. These included a 60% decrease in N-terminal pro b-type natriuretic peptide (NT-proBNP) levels, a biomarker of cardiac stress, and a 35.5-meter increase in the six-minute walk distance (6MWD) corrected for placebo. Interestingly, these results were shown about 24 hours after the intake, showing that the therapeutic effects of TPIP, when taken once daily, are long-lasting.
Regulatory Engagement and Future Trials
Building on these discoveries, Insmed plans to start talking with the FDA in order to complete the design of its Phase 3 clinical program. The company intends to start a Phase 3 research in individuals with pulmonary hypertension linked to interstitial lung disease (PH-ILD) by the end of 2025. It intends to start a second Phase 3 study in PAH patients in early 2026.
A Decade of Innovation Achieved TPIP was created to optimize treprostinil’s therapeutic potential while improving patient convenience and tolerability. After more than a decade of study and development, the Phase 2b trial’s result constitutes a major breakthrough in prostanoid treatment. During an investor call held Tuesday, Insmed (INSM) highlighted exploratory analyses and reiterated its belief in TPIP’s ability to become a leading treatment option for PAH.
