Dyax Provides Update on DX-88 Development for Hereditary Angioedema
Following on positive preclinical study results, Dyax is advancing DX-88 for hereditary angioedema (HAE) into a clinical trial in normal volunteers to evaluate the safety and pharmacokinetics (PK) of a subcutaneous route of administration.
To date, Dyax has successfully completed two Phase II trials in HAE using an intravenous route of administration of DX-88, and a third Phase II trial is ongoing.
As Dyax and Genzyme have previously stated, they believe that a product that is easily self-administered will maximize DX-88's appeal to patients and physicians and greatly enhance its market potential. The subcutaneous DX-88 trial is expected to be completed during the first half of 2005.
Concurrently, Dyax and Genzyme continue their discussions with the FDA to finalize a protocol for their planned multicenter, controlled Phase III trial, for which the route of administration of DX-88 remains to be determined. The companies expect some timeline modification for initiating the Phase III trial, however any delays are not expected to be substantial, and all factors are being considered in order to bring DX-88 to market as rapidly as possible.