Dyax Corp. 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 US 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 US.
The fast track programme 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."
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 US and E.U., as well as fast track designation in the US for the treatment of acute attacks of HAE.