Following soon after United Therapeutics’ announcement that the FDA had cleared an IND for a Phase 2 trial of the company’s treprostinil SMI in patients with PH-COPD, the company has announced an IND clearance for a trial of a second soft mist inhaler product. The second trial is a Phase 1 SAD study of a treprostinil / iloprost SMI, which the announcement notes “would be the first use-as-needed combination inhaled therapy to be developed for pulmonary arterial hypertension (PAH).”
United Therapeutics Senior VP, Global Patient Safety and Strategic Clinical Development, Ravi Patel commented, “Many people living with PAH experience moments when their symptoms flare despite their maintenance medication, and today they have no therapy designed specifically for those moments. treprostinil / iloprost SMI is intended to explore whether an as-needed, combination prostacyclin therapy could help fill that gap. FDA clearance to begin clinical testing is an important first step, and we look forward to advancing this program.”
Chairperson and CEO Martine Rothblatt said, “As a company known for pioneering prostacyclin therapies, treprostinil / iloprost SMI represents another important advancement in United Therapeutics’ PAH treatment portfolio. It also reflects continued innovation from our product development platform and our culture of running down the corridors of indifference in pulmonary medicine.
Read the United Therapeutics press release
