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FDA Clears United Therapeutics to Start Phase 2 Trial for Inhaled Drug Candidate

BullishMedium impact
UTHR$547.31 2.66%

United Therapeutics Corporation (UTHR) has received FDA clearance to advance its investigational drug candidate, treprostinil SMI, into a Phase 2 clinical trial. The 16-week double-blind study, named SUMMIT, will enroll approximately 40 patients to evaluate the safety and tolerability of the soft mist inhaler treatment in individuals with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD).

The trial addresses a major unmet medical need, as PH-COPD is a severe lung condition with no FDA-approved therapies. United Therapeutics estimates that between 400,000 and 800,000 people in the U.S. live with the condition, representing a patient population five to ten times larger than all of the company's existing approved indications combined. Secondary study goals will measure efficacy in improving exercise capacity and reducing heart failure biomarkers.

Looking ahead, a successful outcome in the SUMMIT study could pave the way for a Phase 3 registration trial planned for 2028. United Therapeutics also intends to explore treprostinil SMI for several other respiratory conditions, including pulmonary arterial hypertension and progressive pulmonary fibrosis.

Key points

  • The FDA cleared an investigational application allowing United Therapeutics to start the 16-week Phase 2 SUMMIT trial for treprostinil SMI.
  • The study will evaluate safety, tolerability, exercise capacity, and heart failure biomarkers in roughly 40 patients with PH-COPD.
  • PH-COPD affects an estimated 400,000 to 800,000 Americans and currently has no FDA-approved treatment options.
  • If Phase 2 results are successful, United Therapeutics plans to launch a Phase 3 registration trial in 2028.

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Questions and answers

What is the SUMMIT clinical trial?

The SUMMIT trial is a 16-week Phase 2 study evaluating the safety, tolerability, and secondary efficacy endpoints of treprostinil SMI in about 40 patients with PH-COPD.

Are there any approved treatments for PH-COPD?

No, PH-COPD currently has no FDA-approved treatments available for the estimated 400,000 to 800,000 patients living with the condition in the United States.

When could Phase 3 testing for treprostinil SMI begin?

Pending positive results from the Phase 2 SUMMIT trial, United Therapeutics anticipates starting a Phase 3 registration study in 2028.