United Therapeutics has reported that the Tyvaso (treprostinil) inhalation solution met all primary and secondary endpoints in the Phase III INCREASE trial involving patients with pulmonary hypertension caused by interstitial lung disease (PH-ILD).
Tyvaso is a prostacyclin vasodilator intended to improve exercise ability in pulmonary arterial hypertension patients.
The multi-centre, randomised, double-blinded, placebo-controlled, parallel-group, 16-week INCREASE study compared the drug to placebo in 326 patients. Participants in the treatment group were given up to 12 breaths per session, four times per day.
The primary endpoint was the change in six-minute walk distance (6MWD) from baseline to week 16.
According to preliminary data, Tyvaso met the primary goal with a 21m increase in 6MWD compared to placebo following 16 weeks of treatment.
The drug also led to significant improvements in the trial’s secondary endpoints, including a decrease in the NT-proBNP cardiac biomarker, time to first clinical worsening event, peak 6MWD change at week 12 and trough 6MWD change at week 15.
Results further revealed that Tyvaso was well-tolerated with a safety profile that is consistent with prior PAH data and known prostacyclin-related adverse events.
INCREASE Study Steering Committee chair Aaron Waxman said: “Patients with both interstitial lung disease and pulmonary hypertension have worse clinical trajectories and earlier death than patients with interstitial lung disease alone.
“There are currently no approved therapies for these patients and so there is a tremendous unmet need. This is the largest clinical trial in this population and the first to demonstrate a clear benefit.”
In the coming months, the company will submit the INCREASE trial data to the US Food and Drug Administration (FDA) to seek approval in this indication.
Earlier this month, United Therapeutics reported that Unituxin (dinutuximab) in combination with irinotecan failed to meet the primary endpoint in Phase II/III DISTINCT trial in small cell lung cancer (SCLC).