On the way towards a once-daily oral HAE therapy

In its financial results for the full year ended 31 December 2018 the BioCryst Pharmaceuticals, Inc. President and CEO Jon Stonehouse said:

“In a year with many transformative milestones for BioCryst, it has been exciting to see so much progress already in the first two months of the year. The strong Phase 2 clinical data from our now-completed ZENITH-1 trial propels our BCX7353 acute program for HAE into Phase 3 development. We remain on track for the readout of our APeX-2 trial next quarter, and an NDA filing of BCX7353 for HAE prophylaxis by the end of the year. We are thoughtfully building our commercial leadership and infrastructure to execute a successful launch that meets the urgent demand for a once-daily oral therapy that will allow HAE patients to live a more normal life.”

Upcoming Key Milestones

• Report 24-week safety and efficacy results from the APeX-2 clinical trial (Q2 2019)
• Begin a Phase 3 clinical trial of oral BCX7353 for the acute treatment of HAE (Summer 2019)
• File a new drug application (NDA) for oral BCX7353 for the prevention of HAE attacks with the U.S. Food and Drug Administration (FDA) (Q4 2019)

(Source: BioCryst)