Epix initiates Phase IIb right-heart catheterization study of PRX-08066

PRX-08066 is a serotonin type 2B receptor (5-HT2B) antagonist that may represent a new mechanism of action for treating pulmonary hypertension (PH).

This single-arm, open-label, Phase IIb study is designed to evaluate the mean pulmonary artery blood pressure change from baseline as measured directly by right-heart catheterization and will also measure the change from baseline in the standard six-minute walk distance test after three months of treatment. Patients will be treated with 500mg of PRX-08066 on day one of the trial followed by twice-daily dosing of 300mg of PRX-08066 for three months. The trial is designed to enroll adult patients with chronic obstructive pulmonary disease (COPD) and moderate-to-severe PH.

Elkan Gamzu, interim CEO of Epix, said: “There are currently no approved drugs to treat PH associated with COPD and it is estimated that this disease may affect up to six million people worldwide. These patients have a very poor prognosis and, consequently, there is a significant unmet medical need for an effective treatment.

“We believe that PRX-08066 may be the only 5-HT2B antagonist being developed for PH that has the potential to selectively and safely reduce pulmonary artery blood pressure in these patients without affecting their systemic blood pressure.”