FDA Fast-Tracks Plasma Kallikrein Inhibitor for Angioedema Attacks in HAE
BCX7353 (BioCryst), a novel treatment being developed to treat and prevent angioedema attacks in patients with hereditary angioedema (HAE), has been granted Fast Track Designation by the Food and Drug Administration (FDA).
This investigational agent is an oral, once-daily, selective inhibitor of plasma kallikrein. A Phase 2 trial (APeX-1) found the treatment to be safe and well tolerated, and that compared with placebo, treatment with BCX7353 was associated with a significantly lower rate of confirmed angioedema attacks.
The Company is currently conducting a Phase 3 trial (APeX-2) and a long-term safety study (APeX-S), both evaluating 2 dosage strengths of BCX7353 administered once-daily as a preventive treatment to reduce the frequency of attacks in HAE patients. BioCryst is also testing an oral liquid formulation of the treatment in a proof-of-concept Phase 2 trial.
"We remain focused on completing the Phase 3 program and preparing for an NDA filing in the second half of 2019," said Jon P. Stonehouse, president and CEO of BioCryst.
For more information visit BioCryst.com.