Dyax, Genzyme begin phase 3 trial of DX-88 for hereditary angioedema

By Angela McDaniels

Seattle, Dec. 8 - Dyax Corp. and Genzyme Corp. said that patient treatment has begun in their phase 3 clinical trial of Dyax's DX-88. The trial is being conducted to confirm the efficacy of a subcutaneous administration of DX-88 in patients suffering from moderate to severe acute hereditary angioedema attacks.

The study includes two phases. In the first phase, patients will receive either a single 30 mg subcutaneous dose of DX-88 or a placebo. They will then be eligible for the second phase, where all patients will receive repeat dosing with subcutaneous DX-88 for any subsequent acute attacks.

This trial is planned for 62 patients, including patients previously exposed to DX-88 and naive patients. It will be conducted at 47 sites in the United States and Canada, along with additional clinical sites in Europe and Israel.

The companies said they are targeting U.S. regulatory approval in 2007 and approval in the European Union after that.

The evaluation of DX-88 for hereditary angioedema is being conducted by Dyax under its collaboration with Genzyme. Dyax will receive a $3 million milestone payment from Genzyme for the start of the trial and an additional $10 million milestone payment upon approval of the compound by the U.S. Food and Drug Administration.

Hereditary angioedema is a rare genetic disease that causes acute attacks of localized swelling and inflammation. There is no approved treatment for the disorder in the United States, the companies said.

DX-88 inhibits human plasma kallikrein, which is an enzyme thought to be responsible for the activation of molecules that cause swelling and pain associated with the disorder.

Dyax is based in Cambridge, Mass., and uses its drug discovery technology to identify antibody, small protein and peptide compounds for clinical development.

Genzyme is a biotechnology company that develops products and services to treat rare inherited disorders, kidney disease, cancer, transplant and immune diseases and for diagnostic testing and orthopedics.

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