|Dyax Reports Results of Phase 2 Trial of Ecallantide; Teva Sees Progress in Test of New Copaxone Dosage|
|By Staff and Wire Reports|
|Thursday, 14 June 2012 21:21|
Dyax Corp. (NASDAQ: DYAX) announced the decision to discontinue the Companys Phase 2 trial investigating ecallantide in the acute treatment of angiotensin converting enzyme (ACE) inhibitor-induced angioedema based upon the results of an interim analysis. This double-blind, placebo-controlled, randomized, dose-ranging study was designed to evaluate the efficacy and safety of ecallantide (10, 30, or 60 mg subcutaneous doses) compared to placebo, with a goal of enrolling 176 patients. The primary endpoint was the proportion of patients meeting a set of criteria indicating eligibility for discharge from the emergency department within 6 hours following study drug administration.
Safety was not a factor in the Companys decision to stop the clinical trial. Separately from this interim analysis of the efficacy data, an independent Data Safety Monitoring Board (DSMB) met on May 15, 2012, and reviewed blinded safety data for the first 25% of patients enrolled in the trial. The DSMB did not identify any safety concerns and did not recommend any changes to the conduct of the study.
Prior studies and literature suggested that ACE inhibitor-induced angioedema is complicated by high rates of morbidity, which drove the assumptions used to power the study. This large, multi-center, placebo-controlled trial provided an opportunity to better understand the disease, and, as such, Dyax determined that it would be prudent to conduct an interim analysis of efficacy data.
Data from the first 72 patients treated in the trial suggests a trend favoring a treatment with ecallantide over placebo; however, this trend is not statistically significant. Because the observed response rate to placebo was substantially higher than originally anticipated, the study was determined to be inadequately powered to detect a statistically significant difference between ecallantide and placebo. In addition, based upon the primary endpoint data, the enrolled population does not appear to reproduce the high morbidity described in previous medical literature.
The Company is currently assessing options regarding future investigational efforts in the acute treatment of ACE inhibitor-induced angioedema.
Todays announcement in no way diminishes our commitment to the overall angioedema space and, in particular, to patients with hereditary angioedema, said Dr. Burt Adelman, Chief Medical Officer at Dyax. "These results have no bearing on the use of Kalbitor® (ecallantide) to treat patients during an acute attack of HAE."
"Dyax will continue to actively investigate novel therapeutic approaches for angioedema disorders, including next generation therapies and testing, said Gustav Christensen, President and Chief Executive Officer of Dyax. "These results, while unanticipated, provide us with further evidence and understanding of the biology of angioedema, supporting our efforts to address these disorders and to remain at the forefront of therapeutic innovation."
The Company expects to present a detailed set of results from its ACE inhibitor-induced angioedema study at a future scientific forum.
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) the Jerusalem drug maker, reported progress with a new dosage for its flagship drug, Copaxone, a treatment for multiple sclerosis. A phase III study of the drug given three times a week in a dosage of 40mg met the primary endpoint by reducing the annualized relapse rate in patients by more than 34% compared with placebo, Teva said in a Thursday statement.
The drug proved safe and tolerable at the dosage when taken three times a week. Normally, Copaxone is administered daily in a 20mg dose. The one-year study assessed 1,400 patients at 155 sites worldwide. Teva said it is still analyzing data and will present the results shortly.
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