CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (Nasdaq:DYAX - News) announced today that it has completed the double-blind portion of its pivotal Phase III clinical trial, known as EDEMA3, for its lead product candidate DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). In addition, the U.S. Food and Drug Administration has also broadened the Fast Track designation for DX-88 for the treatment of all types of acute HAE attacks, a rare and life-threatening inflammatory condition for which there is no approved therapy in the United States. The Fast Track program is designed to facilitate the development and expedite regulatory review of investigational drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
The 72-patient, placebo-controlled, multi-center EDEMA3 trial was conducted to determine the efficacy of the 30 mg subcutaneous (SC) dose of DX-88 for patients suffering from moderate to severe acute HAE attacks. The trial is comprised of two phases: a double-blind, placebo-controlled phase and a repeat dosing phase. In the first phase, which is now completed, HAE patients received either a single 30 mg SC dose of DX-88 or placebo. The second phase of the study, which continues to treat patients, allows for open-label SC DX-88 to be administered for acute attacks. The final results of the double-blind phase of the EDEMA3 trial will be made public after the data have been collected, verified, clinical database locked and analyzed.
“The treatment of the final patient in this pivotal Phase III trial and the broadening of the Fast Track designation mark a significant milestone for the DX-88 HAE program,” said Henry E. Blair, Chairman and Chief Executive Officer of Dyax. “We have collected an extensive amount of clinical information to date with approximately 600 doses of DX-88 administered to approximately 250 individuals. Furthermore, DX-88 has continued to demonstrate a good safety profile and has been well tolerated on single and multiple dosing. The rapid completion of this trial, which was the largest placebo-controlled trial conducted for this indication, demonstrates that we have significant support from HAE patients and physicians. We, and our partner Genzyme, remain committed to delivering this treatment to the HAE patient community.”
About Dyax
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development.
Dyax’s lead product candidate is DX-88, a recombinant small protein that is currently in clinical trials for its therapeutic potential in two separate indications. In its joint venture with Genzyme Corporation, Dyax has successfully completed three Phase II trials and a pivotal Phase III trial of DX-88 for the treatment of hereditary angioedema (HAE). A confirmatory study, known as EDEMA4, is planned and expected to begin in the first quarter of 2007. DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S. for the treatment of acute attacks of HAE.
Independently, Dyax has successfully completed a Phase I/II trial of DX-88 for the prevention of blood loss during on-pump CABG procedures. Dyax is currently planning a Phase IIb trial for further development of DX-88 in on-pump cardiothoracic surgery (CTS), including CABG and valve procedures.
Dyax identified DX-88 and other compounds in its pipeline using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents.
Dyax is headquartered in Cambridge, Massachusetts, and has antibody discovery facilities in Liege, Belgium. For online information about Dyax Corp., please visit www.dyax.com.
Dyax Disclaimer
This press release contains forward-looking statements, including statements regarding clinical trials, the potential administration, dosing, safety and therapeutic benefit of DX-88 for HAE, and plans for development of DX-88 for CTS. Statements that are not historical facts are based on Dyax’s current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect clinical trials, the potential administration, dosing and therapeutic benefit of DX-88 for HAE and plans for development of DX-88 for CTS, include the risks that: DX-88 may not show sufficient therapeutic effect or an acceptable safety profile in clinical trials or could take a significantly longer time to gain regulatory approval than Dyax expects or may never gain approval; others may develop technologies or products superior to DX-88 or that are on the market before DX-88; DX-88 may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacture, marketing, sales and distribution of DX-88; and other risk factors described or referred to Item 1A, “Risk Factors” in Dyax’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.
Dyax and the Dyax logo are the registered trademarks of Dyax Corp. EDEMA3 and EDEMA4 are service marks of Dyax Corp.
Contact: Dyax Corp. Ivana Magovcevic-Liebisch, 617-250-5759 General Counsel and Executive Vice President, Corporate Communications imagovcevic@dyax.com or Nicole Jones, 617-250-5744 Associate Director, Investor Relations and Corporate Communications njones@dyax.com
Source: Dyax Corp.
