BioCryst Pharmaceuticals announces the initiation of a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally-administered BCX7353 in healthy volunteers. Discovered by BioCryst, BCX7353 is a novel, selective inhibitor of plasma kallikrein in development for prevention of attacks in patients with HAE. BioCryst has successfully completed nonclinical safety studies, as well as in vitro studies in which BCX7353 exhibited potent and selective inhibition of plasma kallikrein. The pharmacokinetic profile of BCX7353 in preclinical studies indicates its potential for once daily dosing.
“We are pleased to advance BCX7353 into the clinic and look forward to reporting results from this trial during the third quarter 2015. The successful development of a once daily, orally administered prophylactic drug that is safe and efficacious would be a game changer and a convenient treatment alternative for patients suffering from HAE,” said Jon P. Stonehouse, President & CEO of BioCryst.
The main goals of the Phase 1 clinical trial are to assess safety, characterize plasma drug levels in healthy volunteers, and estimate the extent of kallikrein inhibition achieved after oral dosing of BCX7353.
(Source: BioCryst)
