BioCryst presents new data from APeX-S clinical trial evaluating ORDALEYO

BioCryst Pharmaceuticals announced new data from the APeX-S clinical trial, which evaluated oral, once-daily ORLADEYO for the prophylactic treatment of hereditary angioedema, showing sustained reduction in disease burden for patients across multiple subgroups through 96 weeks of treatment. The data are being presented at the 13th C1-inhibitor Deficiency & Angioedema Workshop, which is being held in Budapest, Hungary, from May 4-7, 2023. BioCryst C1-inhibitor Deficiency & Angioedema Workshop Presentation Highlights: "Attack-free status across subgroups of patients with hereditary angioedema after 96 weeks of berotralstat treatment: results from the APeX-S trial;" This analysis assessed the attack-free status of patients receiving ORLADEYO 150 mg through 96 weeks in APeX-S, stratified by baseline age, gender, and prior HAE prophylaxis treatment. Overall, a reduction in mean adjusted HAE attack rates was observed compared to Weeks 0-24 in patients treated with ORLADEYO 150 mg QD. Attack-free status was consistently high through 96 weeks of treatment with ORLADEYO 150 mg regardless of patients’ age, gender and prior prophylactic treatment. Patients aged 12-17, 18-64 and greater than or equal to 65 remained attack free an average of 97, 94 and 98 percent of days. Female patients remained attack free an average of 94 percent of days. Male patients remained attack free an average of 94 percent of days. Patients who had prior treatment with androgens remained attack free an average of 93 percent of days. Patients who had prior treatment with C1-inhibitors remained attack free an average of 91 percent of days. Long-term prophylaxis with ORLADEYO 150 mg led to a durable treatment effect and sustained reduction in disease burden through 96 weeks of treatment regardless of baseline characteristics including patients’ age, gender and prior prophylactic treatment.