BioCryst Pharma (BCRX) Does First Patient in BCX7353 APeX-1 Study

August 11, 2016 10:19 AM EDT

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BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that it has dosed the first subject in the APeX-1 clinical trial of BCX7353 for the oral treatment of hereditary angioedema (HAE).

“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,” said William P Sheridan, SVP & Chief Medical Officer at BioCryst. “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.”

APeX-1 is a two part, Phase 2, randomized, double-blind, placebo-controlled dose ranging trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of BCX7353 as a preventative treatment to eliminate or reduce the frequency of angioedema attacks in HAE patients. Up to approximately 50 eligible subjects with HAE will be enrolled in the study.

“The APeX-1 trial is an exciting opportunity for the HAE patient community.” said Dr. Emel Aygören-Pürsün, M.D., Head of Angioedema Clinic, Goethe University Hospital Frankfurt/Main Pediatric Clinic, Frankfurt, Germany, and Principal Investigator for APeX-1. “The value of an effective & well tolerated oral preventive treatment for HAE patients cannot be overestimated."



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