Insmed has announced that a Phase 2b study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension met its primary endpoint, demonstrating a 35% reduction from baseline in pulmonary vascular resistance. The company said that the trial also met all secondary efficacy endpoints, including significant improvement in six-minute walk distance. Insmed says that it now plans to advance TPIP into Phase 3 trials, with a Phase 3 study in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) anticipated by the end of this year and another in patients with PAH early next year.
The Phase 2b trial enrolled 102 PAH patients who received either TPIP or placebo once a day over 16 weeks. During the first 5 weeks of the study, 75% of the patients were able to increase from an 80 µg dose of TPIP to the maximum 640 µg dose. Approximately 6% of patients receiving TPIP experienced adverse reactions that caused them to discontinue participation in the trial, with the most common adverse reactions in the TPIP group being cough and headache. The company reports that 90% of the patients who received TPIP completed the study and 95% of those patients enrolled in an open-label extension study which will evaluate doses up to 1,280 µg daily.
Insmed Chief Product Strategy Officer Gene Sullivan commented, “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. TPIP was designed with the goal of fully harnessing the potential of treprostinil and providing meaningful benefit to patients. 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. We look forward to expanding upon these results in the upcoming Phase 3 program.”
Chief Medical Officer Martina Flammer said, “Today’s outstanding results for TPIP represent more than a decade of hard work and the application of innovative chemistry intended to deliver a safe and effective, once-daily inhaled prostanoid therapy for patients with PAH, a devastating, progressive disease. Having met the primary endpoint with high statistical significance, as well as seeing positive results for all secondary efficacy endpoints, we are excited about TPIP’s potential to become the prostanoid of choice. Thank you to the many patients and clinicians who participated in this study and contributed to today’s historic outcome.”
Read the Insmed press release
