Insmed Incorporated (NASDAQ:INSM) shares surged more than 27% after the company unveiled positive results from a Phase 2b of its once-daily pulmonary arterial hypertension (PAH) therapy, treprostinil palmitil inhalation powder (TPIP).
The randomized, double-blind, placebo-controlled study met its primary endpoint as well as all secondary efficacy endpoints.
The primary endpoint showed a 35% placebo-adjusted reduction from baseline in pulmonary vascular resistance.
For the secondary endpoints, TPIP demonstrated a placebo-adjusted improvement of 35.5 meters in six-minute walk distance and a 60% reduction in N-terminal pro b-type natriuretic peptide concentrations, a biomarker for cardiac stress.
The results were assessed about 24 hours after administration of the drug, demonstrating a sustained benefit through the 24-hour dosing period.
"The statistically significant and clinically meaningful results shown with TPIP in pulmonary arterial hypertension mark a potential breakthrough for patients and the future of prostanoid therapy," Insmed chief product strategy officer Dr Gene Sullivan said in a statement.
“These unprecedented Phase 2b results unequivocally demonstrate TPIP's potential to be a highly effective and well-tolerated once-daily prostanoid therapy for the treatment of PAH across disease severities and background treatment regimens.”
The company said it will immediately engage with the US Food and Drug Administration regarding a Phase 3 trial design.
It intends to commence a Phase 3 trial in patients with pulmonary hypertension associated with interstitial lung disease by the year-end, and a second Phase 3 trial in patients with PAH next year.
Shares of Insmed traded up 27.1% at about $90 on Tuesday morning.