BioCryst Pharmmaceuticals Inc. (BCRX), a biotechnology company, on Friday released new data from the real-world APeX-P study for ORLADEYO and the Phase 1b/2 ALPHA-STAR for Navenibart in treating hereditary angioedema.
ORLADEYO (berotralstat) is an oral prophylactic therapy that increases plasma kallikrein to treat hereditary angioedema (HAE), and received approval for the same from the U.S. Food and Drug Administration (FDA) in 2020.
The APeX-P trial is an ongoing, open-label study evaluating ORLADEYO as a once-daily dose over 48 weeks in patients with HAE due to a C1-inhibitor deficiency.
Results indicated that ORLADEYO- treated patients had 0.169 HAE attacks per month, compared to 0.691 HAE attacks while on standard-of-care (SOC) therapies. Patients on (SOC) showed an average of 22 attacks in 12 weeks, which decreased to 3 attacks in 12 weeks on ORLADEYO.
The company is also developing Navenibart, an investigational YTE-modified monoclonal antibody inhibitor of plasma kallikrein, for the long-term prevention of HAE attacks by administration every 3 to 6 months.
The Phase 1b/2 ALPHA-STAR multicenter, dose-ranging, proof-of-concept, open-label trial evaluated the safety and efficacy of single- and multi-dose navenibart in patients with HAE due to a C1-inhibitor deficiency.
Data released by the company suggests that patients across various body-mass-index (BMI) subgroups and ages showed reduced frequency of moderate to severe HAE attacks when treated with navenibart. Additionally, clinically relevant HAE outcomes in a baseline attack rate subgroup analysis and reduced on-demand medication use were observed in treated patients. The drug was found to be generally well-tolerated.
The company believes that these results support further analysis in the ongoing Phase 3 ALPHA-ORBIT trial for navenibart as a long-acting treatment for HAE.
BCRX is currently trading at $8.69, up 2.24%.
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