BioCryst Pharmaceuticals, Inc. has announced the financial results for the first quarter ended March 31, 2017.
“We have completed enrollment in Part 1 and 2 of the APeX-1 Phase 2 clinical trial of BCX7353 for prevention of angioedema attacks and will report top-line data in the second quarter of 2017 as planned,” said Jon P. Stonehouse, President & CEO. “Enrollment in Part 3 has begun, and at the current enrollment pace, we expect to report complete APeX-1 results in the third quarter of 2017.”
From the Clinical Development Update & Outlook:
- On February 27, BioCryst announced positive results from an interim analysis of Part 1 of the APeX-1 trial for the prevention of attacks in HAE patients. Following 28 days of dosing with 350 mg once daily BCX7353 or placebo, an overall reduction of 0.57 attacks/week (63%, p = 0.006) was observed in BCX7353-treated subjects, with reductions of 88% and 24% respectively in peripheral and abdominal attacks. Based upon additional post-hoc analyses, it appeared that subjects may have recorded transient abdominal adverse events as HAE attack symptoms. Oral BCX7353 350 mg once-daily for 28 days was generally safe and well tolerated in subjects with HAE. Evaluation of lower dose cohorts is ongoing in Part 2 and 3 of the APeX-1 trial.
- On April 12, BioCryst announced plans to explore a new oral liquid formulation of BCX7353 for the treatment of acute attacks in patients with HAE. The Company has received initial regulatory approvals in Europe to initiate the ZENITH-1 exploratory clinical trial, anticipated to start this summer. The goal of the trial is to explore whether single oral doses of a liquid formulation of BCX7353 could have utility in the treatment of acute angioedema attacks in patients with HAE. ZENITH-1 is designed as a randomized, double-blind, placebo controlled, dose-ranging clinical trial with BCX7353 self-administered at home to treat attacks.