United Therapeutics secures FDA clearance for SUMMIT trial

Full story: https://grafa.com/en/news/united-states/united-therapeutics-fda-clearance-summit-treprostinil-trial

• United Therapeutics received authorization to proceed with its Phase 2 SUMMIT trial of treprostinil SMI for pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD).

• The 16-week study will evaluate safety and tolerability in approximately 40 patients, with secondary endpoints measuring exercise capacity and the heart-related biomarker NT-proBNP.

• United Therapeutics anticipates beginning a Phase 3 registration study in 2028, provided the Phase 2 results are successful.

United Therapeutics (NASDAQ:UTHR) received FDA clearance to proceed with a Phase 2 trial of treprostinil SMI for pulmonary hypertension associated with COPD.

The 16-week, double-blind SUMMIT study will enroll approximately 40 patients, focusing on safety and tolerability rather than demonstrating confirmed treatment effectiveness.

“We believe that inhaled treprostinil, delivered via a soft mist inhaler, may benefit the carefully defined SUMMIT PH-COPD patient population,” said United Therapeutics Development Head Leigh Peterson.

Secondary endpoints will assess exercise capacity and NT-proBNP levels, while eligible participants may join an extension study evaluating longer-term treatment outcomes.

United Therapeutics anticipates beginning Phase 3 testing in 2028 if SUMMIT succeeds, although commercial approval remains uncertain.

Treprostinil SMI uses a handheld inhaler designed for single-breath delivery, four daily administrations and cartridges intended to last approximately two weeks.

The company is also developing the investigational inhaler for pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease and two pulmonary fibrosis conditions.