Dyax and Genzyme initiate phase III trial of DX-88 for the treatment of hereditary angioedema

Journal of Drugs in Dermatology, Feb, 2006

Dyax and Genzyme Corporations recently announced the initiation of Phase 3 trials of DX-88, a recombinant plasma kallikrein inhibitor, for the treatment of patients with hereditary angioedema. Patients with hereditary angioedema suffer from acute attacks of swelling and inflammation. Plasma kallikrein is thought to play an integral role in the inflammatory cascade thought to lead to acute episodes of angioedema in patients with this condition. DX-88, by inhibiting plasma kallikrein, can potentially thwart these devastating attacks.

The Phase 3 study named the EDEMA3 trial will enroll 62 patients across centers in the US, Canada, Europe, and Israel. The study is a double-blind placebo-controlled trial in which patients will either receive a 30 mg subcutaneous injection of DX-88 or placebo. After patients receive one treatment in this arm of the study they will be eligible to enter a second phase in which all patients will receive DX-88 for any subsequent episodes on acute angioedema.

Currently, there is no medication in the US approved for the treatment of hereditary angioedema. Dyax and Genzyme are planning for regulatory approval in the US in 2007.