WASHINGTON (dpa-AFX) - United Therapeutics (UTHR) announced the FDA has granted clearance under the investigational new drug application to proceed with the SUMMIT clinical trial of treprostinil SMI in PH-COPD. The phase 2, 16-week, double blind SUMMIT study will evaluate the safety and tolerability of treprostinil SMI in approximately 40 patients with PH-COPD. Assuming a successful outcome in the SUMMIT study, the company expects commencing a subsequent phase 3 registration study for treprostinil SMI in PH-COPD in 2028.
United Therapeutics also plans to develop treprostinil SMI for pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, idiopathic pulmonary fibrosis, and progressive pulmonary fibrosis.
At last close on NasdaqGS, United Therapeutics shares were trading at $533.12.
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