BioCryst Presents New Long-term and Real-world Data Demonstrating Sustained Reductions in Hereditary Angioedema Attack Rates and Improvement in Quality of Life with ORLADEYO (berotralstat)
— Final safety and effectiveness analysis from APeX-S showed ORLADEYO 150 mg resulted in a median attack rate of 0.0 attacks per month in 20 of 24 months
RESEARCH TRIANGLE PARK, N.C., Feb. 24, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new data from the APeX-S and APeX-2 clinical trials which evaluated oral, once-daily ORLADEYO (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) demonstrating sustained reductions in attack rates and improvement in quality of life (QoL) among patients living with HAE, highlighting its profile as a well-tolerated, effective and convenient prophylactic HAE therapeutic option.
The company also announced additional analyses from new real-world data that further demonstrate a meaningful reduction in attack rates experienced by patients on ORLADEYO, in addition to findings from a survey that underscore a significant disease and treatment burden among pediatric HAE patients, as reported by their caregivers.
The data are being presented at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, which is being held in San Antonio, Texas, from February 24-27, 2023.
“The final results from the long-term APeX-S study show that ORLADEYO was consistently well-tolerated, with no new safety signals observed, and attack reduction was sustained through 96 weeks. These results are complemented by the analyses from APeX-2, in which clinically meaningful patient-reported improvements in QoL across subgroups was shown at 96 weeks,” said Emel Aygören-Pürsün, M.D., Internal Medicine and Hemostaseology, Division of Oncology, Hematology and Hemostaseology, Department for Children and Adolescents, University Hospital Frankfurt.
“We are excited to report the final results of our ORLADEYO clinical studies, as these new datasets are being reinforced by what we have observed in the real-world use of ORLADEYO. This real-world evidence supports the continued need for an oral, once-daily option for patients and physicians who are seeking control of their HAE attacks,” said Dr. Ryan Arnold, chief medical officer of BioCryst.
BioCryst AAAAI 2023 Presentation Highlights
The posters being presented at AAAAI include analyses from the APeX-2 and APeX-S clinical studies, as well as real-world data from patients taking ORLADEYO in the United States. APeX-2 was a Phase 3, double-blind, placebo-controlled, parallel-group, three-part study evaluating ORLADEYO versus placebo for the prevention of HAE attacks in patients with HAE Type I or Type II. APeX-S was a Phase 2, open label, international study evaluating the safety and effectiveness of ORLADEYO 110 mg once daily (QD) and 150 mg QD in patients with HAE Type I or Type II for up to 96 weeks in the US and 240 weeks in all other countries.