Strong data for Dyax' HAE drug

USA-based Dyax reported positive top-line results from a Phase III, placebo-controlled trial, EDEMA3, assessing its lead product candidate, DX-88 (ecallantide), in hereditary angiedema (HAE). The recombinant, plasma kallikrein inhibitor achieved statistically-significant results for both the primary and secondary endpoints in the study, Dyax noted.

The primary endpoint, symptom improvement at four hours measured by a Treatment Outcome Score developed for HAE attacks, had a p-value of 0.021. The two secondary endpoints also demonstrated statistical significance. The patient-reported assessment of individual symptom burden at four hours, measured using the Mean Symptom Complex Severity score, had a p-value of 0.024. Time-to-significant improvement in overall response had a median time of 149 minutes for the DX-88 group versus greater than four hours for the placebo group (p=0.044).

Dyax noted that EDEMA3 is the largest successfully completed, placebo-controlled trial for this indication under a US Investigational New Drug application. The results will be presented next week in more detail, the firm added.