BioCryst Pharmaceuticals announced this week that the APeX-1 clinical trial involving BCX7353, which is designed to treat hereditary angioedema (HAE), has begun with the first patient being dosed.
“We are very pleased that the adaptively-designed APeX-1 trial is now under way, and look forward to reporting Part 1 results around the end of 2016,” SVP and Chief Medical Officer William P. Sheridan said. “Results of the Phase 1 study of ’7353 support its potential to provide a normal life to HAE patients as a once-daily oral treatment by increasing kallikrein inhibition to normal levels.”
The clinical trial is a Phase II trial consisting of two parts. It is randomized, double-blind and placebo-controlled that will study BCX7353’s safety, tolerability, pharmacokinetics, pharmacodynamics and efficiency during the trial to determine if the drug can prevent, eliminate and/or reduce the occurrence of angioedema attacks in HAE patients.
“The APeX-1 trial is an exciting opportunity for the HAE patient community,” Head of the Angioedema Clinic at Goethe University Hospital and Main Pediatric Clinic in Frankfurt, Germany, and Principal Investigator for APeX-1 Dr. Emel Aygoren-Pursun said. “The value of an effective and well tolerated oral preventive treatment for HAE patients cannot be overestimated."
HAE is a rare, debilitating and potentially fatal genetic condition that occurs in approximately one in 50,000 people. Its symptoms include recurrent episodes of edema in various locations, including the hands, feet, face, and airways.