BioCryst Reports Additional Positive Results From the Second Interim Analysis of Its APeX-1 Trial
RESEARCH TRIANGLE PARK, N.C., May 25, 2017 -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced results from a second interim analysis of its Phase 2 APeX-1 clinical trial in hereditary angioedema (HAE). APeX-1 is a 3-part dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered once-daily (QD) BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE patients. This second interim analysis evaluated data from all patients in Parts 1 and 2 of the trial. The first interim analysis evaluated data from 28 of 36 patients in Part 1.
“These data support our hypothesis regarding the initial findings seen from the first interim analysis,” said Jon Stonehouse, Chief Executive Officer & President of BioCryst. "We are delighted to see that a daily dose of 125 mg of BCX7353 results in a high level of efficacy with an improved tolerability profile compared to the 350 mg dose observed in the first interim analysis. We look forward to completing Part 3 of the trial to select appropriate doses for our pivotal program.”
- Published: 25 May 2017
- Written by Editor