Dyax announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigation of DX-2930 for hereditary angioedema (HAE).
The Breakthrough Therapy designation is based upon interim results of a Phase 1b clinical trial of DX-2930 in HAE patients. The Phase 1b study met all objectives assessing safety, tolerability and pharmacokinetics of multiple subcutaneous administrations of DX-2930. In a pre-specified proof-of-concept efficacy analysis, DX-2930 demonstrated statistically significant reductions in attack rate compared to placebo.
DX-2930 is an investigational fully human monoclonal antibody inhibitor of plasma kallikrein.
For more information visit Dyax.com.