BioCryst Pharmaceuticals has announced financial results for the third quarter ended September 30, 2014.
Extracts from the report:
“The primary focus continues to be our oral kallikrein inhibitor program for HAE. Preparations are underway for our OPuS-2 clinical trial of BCX4161 and we expect to begin enrolling HAE patients before year end. We continue to make progress with our second generation HAE program and remain on track to enter Phase 1 clinical development in the second quarter of 2015,” said Jon P. Stonehouse, President & CEO of BioCryst.
Activities are underway to initiate the (Oral ProphylaxiS-2) OPuS-2 clinical trial of BCX4161 before the end of 2014. OPuS-2 is a 12-week, three-arm, parallel cohort design trial to evaluate the efficacy and safety of two different dose regimens of BCX4161 administered three-times daily, 300 mg and 500 mg, compared with placebo. The trial, to be conducted in the U.S. and selected European countries, is expected to enroll approximately 100 HAE patients whose average historical attack rate is lower than that observed for patients enrolled in OPuS-1. The primary efficacy endpoint for the trial will be the mean angioedema attack rate for each BCX4161 dose group compared to placebo. The OPuS-2 trial will use 100 mg soft-gel capsules that have demonstrated relative bioavailability of approximately 80% compared with the hard gel capsule formulation used in OPuS-1, which tested 400mg three-times daily.
Non-clinical safety studies for two second generation compounds for the treatment of HAE are progressing as planned, and first-in-human clinical trials are expected to begin during the second quarter of 2015.