BioCryst Pharmaceuticals, Inc. announces the dosing of the first patient into APeX-2, a Phase 3 clinical trial evaluating two dosage strengths of BCX7353 administered orally once-daily (QD) as a preventive treatment to reduce the frequency of attacks in patients with HAE.
“The ability to safely prevent attacks of angioedema with an oral medicine has been a dream for many HAE patients. Today marks a significant milestone toward the realization of that dream,” said Bruce Zuraw, MD and Principal Investigator of the APeX-2 trial. “I am excited to be able to participate in this important trial, which we believe will lead to an effective oral prophylactic treatment offering HAE patients the opportunity to lead a normal life.”
APeX-2 is a randomized, double-blind, placebo-controlled, three-arm trial testing two doses of BCX7353 (110 mg and 150 mg) for prevention of angioedema attacks. The trial is expected to enroll approximately 100 patients with Type I and II HAE in the United States, Canada, and Europe. The primary efficacy endpoint of APeX-2 is the rate of angioedema attacks over 24 weeks of study drug administration.
“Beginning dosing in the APeX-2 pivotal trial of BCX7353 brings us one step closer to providing a once-daily, oral prophylactic treatment to HAE patients. Our entire organization is encouraged and excited by this important milestone, largely because both physicians and patients have told us they are waiting for a convenient and efficacious HAE treatment that allows patients to lead a more normal life,” said Jon Stonehouse, CEO of BioCryst. “We look forward to reporting top-line results from the APeX-2 Phase 3 trial in the first half of 2019.”