According to United Therapeutics, the FDA has cleared the company’s IND for the 16-week Phase 2 SUMMIT trial of treprostinil SMI in patients with pulmonary hypertension associated with COPD, which is expected to enroll approximately 40 patients. The company says that it expects to initiate a Phase 3 study of the SMI for that indication in 2028 if the Phase 2 trial is successful.
The announcement notes that the treprostinil SMI is a cartridge-based device that will deliver a treprostinil inhalation solution that includes a preservative and can be stored at room temperature. Dosing is expected to be four times per day, with each cartridge lasting up to two weeks. United Therapeutics says that it intends to develop treprostinil SMI for a number of other indications in addition to PH-COPD.
After a favorable US District Court ruling for United Therapeutics in its long-running patent litigation related to Liquidia’s Yutrepia treprostinil DPI, Liquidia recently announced a settlement that would allow it to continue marketing Yutrepia for the treatment of PAH. At that time, Liquidia noted that it would continue developing Yutrepia for the treatment of PH-COPD.
United Therapeutics Head of Pharmaceutical and Xenograft Development Leigh Peterson commented, “PH-COPD is a serious, life-threatening condition with no approved treatments. We believe that inhaled treprostinil, delivered via a soft mist inhaler, may benefit the carefully defined SUMMIT PH-COPD patient population by directly targeting the pulmonary vasculature. Our hope is that treprostinil SMI will offer meaningful benefit and reduce disease burden for PH-COPD patients who deserve a treatment option that addresses their significant unmet needs.”
Chairperson and CEO Martine Rothblatt said, “I believe this development will lead to an exponential inflection point for United Therapeutics. We estimate PH-COPD could impact five to ten times the number of patients than the conditions all of our current therapies are approved to treat today. Upon successful completion of the SUMMIT program and approval by the FDA, we expect United Therapeutics will become a several times larger company than it is today.”
Read the United Therapeutics press release
