BioCryst starts BCX4161 Phase 1 clinical trial for treatment of hereditary angioedema

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced the initiation of a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally-administered BCX4161 in healthy volunteers. Discovered by BioCryst, BCX4161 is a novel, selective inhibitor of plasma kallikrein in development for prevention of attacks in patients with hereditary angioedema (HAE).

“BCX4161 has the potential to be the first oral treatment developed specifically for the prevention of HAE attacks.”

"Daily, oral administration of a safe and efficacious prophylactic drug would revolutionize treatment for patients suffering from this serious condition," said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. "BCX4161 has the potential to be the first oral treatment developed specifically for the prevention of HAE attacks."

BioCryst has successfully completed nonclinical safety studies, as well as in vitro and in vivo studies in which BCX4161 exhibited potent and selective inhibition of plasma kallikrein and a favorable safety profile. A poster titled "BCX4161, A Small Molecule Orally Bioavailable Plasma Kallikrein Inhibitor, for the Treatment of Hereditary Angioedema" was presented at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in February.

The main goals of the Phase 1 clinical trial are to assess safety, characterize plasma drug levels, and estimate the extent of kallikrein inhibition achieved after oral dosing of BCX4161. This clinical trial is being conducted at Quotient Clinical in the United Kingdom utilizing an integrated Translational Pharmaceutics^TM platform and the results are expected to be announced in 2013. If the Phase 1 program achieves its goals, BioCryst plans to initiate a Phase 2 program in HAE patients.