Dyax and Genzyme Initiate Pivotal Phase III Trial of Subcutaneously Administered DX-88 for Treatment of Hereditary Angioedema
Dyax Corp. and Genzyme Corporation announced that patient treatment has begun in their pivotal Phase III clinical trial of Dyax's recombinant plasma kallikrein inhibitor known as DX-88. In this trial, referred to as EDEMA3, DX-88 is being studied for the treatment of patients with hereditary angioedema (HAE), a rare, genetic disease that causes acute attacks of localized swelling and inflammation.
The EDEMA3 trial is being conducted to confirm efficacy of a subcutaneous administration of DX-88 in patients suffering from moderate to severe acute HAE attacks. DX-88 inhibits human plasma kallikrein, which is an enzyme that is thought to be responsible for the activation of molecules that cause swelling and pain associated with HAE.
The evaluation of DX-88 in the HAE indication is being conducted by Dyax under its collaboration with Genzyme Corporation. In this joint venture, Dyax will now receive a $3 million milestone payment from Genzyme for the start of the pivotal trial and will receive an additional $10 million milestone payment upon FDA approval of the compound.
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