BioCryst Pharma announces results from a second interim analysis of its Phase 2 APeX-1 clinical trial in hereditary angioedema; 'strongly supports its continued investigation as a prophylactic treatment for HAE' :
This second interim analysis of pooled data from Parts 1 and 2 evaluated doses of BCX7353 125 mg (n=7), 250 mg (n=6) and 350 mg (n=18) QD versus placebo (n=20) for 28 days. The baseline attack rate was ~1/week.
- Baseline characteristics were generally well balanced between the treatment groups.
- Compliance with study drug dosing was excellent (= 98%).
- A pre-planned analysis of peripheral and abdominal attacks showed reductions in peripheral attacks of 74% (125 mg QD), 54% (250 mg QD) and 90% (350 mg QD) compared with placebo (PP analysis, weeks 2 through 4) and reductions in abdominal attacks of 72% (125 mg QD), 10% (250 mg QD) and 8% (350 mg QD) compared with placebo (PP analysis, weeks 2 through 4).
- Based on this distribution, it is likely that subjects in the 250 mg and 350 mg arms recorded transient abdominal adverse events (AEs) as HAE attack symptoms in their diary. In contrast, a consistent reduction in attacks regardless of anatomical location was observed in the 125 mg arm.
- Steady state BCX7353 plasma levels and kallikrein inhibition levels in HAE subjects were similar to those seen in healthy subjects administered the same doses in a previously completed Phase 1 trial.
- Steady state trough drug levels (24 hours after dosing) greatly exceeded the target therapeutic range at the 250 mg and 350 mg dose levels. Trough levels for the 125 mg dose were generally within the target range.
- Co states, "The efficacy, safety and tolerability profile of BCX7353 observed in this interim analysis strongly supports its continued investigation as a prophylactic treatment for HAE. Enrollment into Part 3 of the trial is progressing well."
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