BioCryst Pharmaceuticals announced initial results from the ZENITH-1 trial showing that a single 750 mg oral dose of BCX7353 was well tolerated and superior to placebo against the majority of efficacy endpoints evaluated in HAE patients suffering an acute attack. BCX7353 is a novel oral plasma kallikrein inhibitor being developed for both prophylactic and acute treatment of HAE attacks. In the 750 mg dose cohort of the trial, which has completed, 33 patients treated a total of 95 attacks. Patients self-treated their HAE attacks on a blinded basis with oral BCX7353 or oral placebo and recorded their symptoms and attack severity using both a Visual Analog Scale and a standardized questionnaire. Patients also recorded the time they used any standard-of-care acute treatment medicine. BCX7353 was superior to placebo for multiple clinical outcomes. Results from the ongoing evaluation of the 250 mg and 500 mg dose levels of oral BCX7353 in ZENITH-1 are expected in the first quarter of 2019.
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