BioCryst’s berotralstat long term study suggests reductions in attack rate

New data from APeX-2 and APeX-S trials of BioCryst Pharmaceuticals’s (BCRX +6.2%) once-daily oral berotralstat demonstrated sustained decrease in attack frequency and improvements in quality of life scores over 48 weeks, in hereditary angioedema (“HAE”) patients.

Berotralstat was also safe and generally well-tolerated over 48 weeks in total of 342 patients with 232 patient-years of daily oral dosing.

Gastrointestinal events led to discontinuation of berotralstat in 3.2% of patients.

Drug-related serious adverse events occurred in three of 342 subjects and resolved after stopping or interrupting dosing.

In APeX-2, 31 patients were randomized to 150 mg of berotralstat and at 48 weeks had a mean baseline attack rate of 2.9 attacks per month, which declined to 1.5 attacks per month after one month and to 1.0 attack per month at 12 months.

In APeX-S, patients completing 48 weeks on 150 mg (n=73) had a median attack rate of zero attacks per month in six of the 12 months, including month 12 (week 48).

https://seekingalpha.com/news/3581231-biocrysts-berotralstat-long-term-study-suggests-reductions-in-attack-rate