Dyax Gets Orphan Drug Status For DX-2930 In Hereditary Angioedema - Quick Facts

(RTTNews) - The U.S. Food and Drug Administration or FDA has granted orphan drug designation to Dyax Corp.'s (DYAX) drug candidate DX-2930, its fully human monoclonal antibody inhibitor of plasma kallikrein, to treat hereditary angioedema or HAE.

Dyax is developing DX-2930 to be a long-acting, prophylactic agent that prevents HAE attacks. Development plans consist of a dosage formulation that will permit infrequent self-administration by small volume, subcutaneous injection. Currently, DX-2930 is being studied in a placebo-controlled, dose-escalation Phase 1 study in normal individuals. The trial results are expected in the first quarter of 2014.

Dyax' President and Chief Executive said, "There is still a significant unmet medical need within the HAE community which we plan to address with DX-2930. Orphan drug designation is an important element of our development strategy for DX-2930 as we work to further improve the health and quality of life for individuals suffering from this painful and often debilitating condition."