BioCryst: OPuS-1 Phase 2a Trial Of BCX4161 Meets Primary Efficacy Endpoint

(RTTNews) - BioCryst Pharmaceuticals, Inc. (BCRX) announced preliminary results from its OPuS-1 (Oral ProphylaxiS-1) proof of concept Phase 2a clinical trial of orally-administered BCX4161 in patients with hereditary angioedema. The trial met the primary efficacy endpoint, several secondary endpoints and all other objectives established for the trial.

"The efficacy and safety profile of BCX4161 seen in the OPuS-1 trial strongly support its continued development. We look forward to working with clinical investigators, the HAE community and regulatory authorities in advancing BCX4161 to the next stage and starting the OPuS-2, 12-week trial later this year," said William Sheridan, Chief Medical Officer at BioCryst.

OPuS-1 evaluated 400 mg of BCX4161 administered three times a day for 28 days in HAE patients with a high attack frequency in a randomized, placebo-controlled, two-period cross-over design. The primary goals for the trial were to estimate the degree of efficacy of BCX4161 in reducing the frequency of angioedema attacks, and to evaluate the safety and tolerability of 28 days of BCX4161 treatment. Treatment with BCX4161 demonstrated a statistically significant mean attack rate reduction of 0.45 attacks per week versus placebo, the company said.

Oral administration of BCX4161 was generally safe and well tolerated, with an adverse event profile similar to that observed for placebo, the company said.