Posted by Michael Wonder on 06 Aug 2018
U.S. FDA grants fast track designation for BioCryst’s BCX7353
6 August 2018 - BioCryst Pharmaceuticals today announced that the Company has been granted fast track designation by the U.S. FDA for BCX7353 for the prevention of angioedema attacks in patients with hereditary angioedema.
Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with hereditary angioedema (HAE). BCX7353 was generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is currently conducting the Phase 3 APeX-2 clinical trial and the long-term safety APeX-S clinical trial, both evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. BioCryst is also conducting the ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the acute treatment of angioedema attacks.
