BioCryst Pharma To Begin Phase 2a Trial Of Oral Kallikrein Inhibitor BCX4161

(RTTNews) - Biotechnology company BioCryst Pharmaceuticals, Inc. (BCRX), Monday said it expects to begin the Phase 2a clinical trial of BCX4161 in patients with Hereditary Angioedema or HAE in the fourth quarter, after the Phase 1 clinical trial of orally-administered BCX4161 with healthy volunteers successfully met all of its objectives of safety, tolerability, drug exposure and on-target kallikrein inhibition.

The Phase 2a clinical trial will test 400 mg of the BCX4161 administered three times daily for 28 days in a randomized, placebo-controlled, two-period cross-over design, in about 25 HAE patients who have a high frequency of attacks. The goals for the trial are to evaluate the safety and tolerability of BCX4161 and to estimate the degree of efficacy in reducing the frequency of attacks.

BCX4161 is a selective inhibitor of plasma kallikrein in development for prevention of attacks in patients with HAE. By inhibiting plasma kallikrein, BCX4161 suppresses bradykinin production. Bradykinin is the mediator of acute swelling attacks in HAE patients.

"If BCX4161 fulfills the promise shown in this study, it will provide a more effective alternative to androgens, currently the mainstay of oral HAE treatment, with substantially less side effects. BCX4161 has the potential to be an important new treatment for optimally managing patients with HAE."