Dyax Corp. (Nasdaq: DYAX) is a clinical-stage drug company focused on the discovery, development and commercialization of biotherapeutics for oncology and inflammatory conditions. The company today announced positive topline results from its second phase-3, placebo-controlled trial, EDEMA4, for its lead product candidate DX-88 (ecallantide) for hereditary angioedema (HAE), or the rapid swelling of the skin.
The trial utilized the participation of 96 patients and was conducted at 42 sites in the United States and Canada. The company’s anticipated goal was to determine the efficacy and safety of a fixed 30 mg. subcutaneous dose of DX-88 in the treatment of moderate to severe acute HAE attacks.
The EDEMA4 trial was conducted under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA) and marked significant improvements in the intent-to-treat population in primary and secondary endpoints. The trial was consistent with outcomes of the first phase 3 placebo-controlled trial (EDEMA3) for HAE.
“The positive results from our EDEMA4 and EDEMA3 trials support the potential of DX-88 as an important acute therapy for HAE patients. Moreover, DX-88’s profile as a recombinant, subcutaneous therapy, may offer treatment advantages to patients suffering from this debilitating and life-threatening disease,” William E. Pullman, M.D., Ph.D., FRACP, executive vice president and chief development officer of Dyax stated in the press release.
Based on the safety and efficacy results from the two trials, Dyax plans on submitting the last module of its Biologics License Application (BLA) to the FDA early in the fourth quarter of 2008.
“We are extremely pleased that the EDEMA4 results validate the promise of DX-88 as a potential treatment solution for the HAE community,” Henry E. Blair, chairman, president and CEO stated. “The DX-88 BLA will include the most extensive placebo-controlled assessment of any therapy for the treatment of HAE and was based on a Dyax-developed comprehensive endpoint evaluation. We look forward to submitting our BLA and, ultimately, commercializing this innovative therapy.”
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