Been away in Tuscany, so missed Friday's top, but nice surprise anyhow -
DX-88 for Hereditary Angioedema Meets Primary and Secondary Endpoints in Phase 3 Trial (EDEMA3(R))
Thursday April 12, 4:01 pm ET
Dyax Corp. to Discuss Results in Webcast Presentation with Investigators
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (Nasdaq:DYAX - News) announced today positive topline results from its Phase 3, placebo-controlled trial, EDEMA3, for its lead product candidate DX-88 (ecallantide), for hereditary angioedema (HAE). A webcast presentation of the EDEMA3 data is scheduled for Tuesday, April 17, 2007 at 12:30 p.m. ET.
DX-88, an internally discovered, recombinant, plasma kallikrein inhibitor, is in clinical trials for the treatment of acute attacks of HAE, a rare genetic disease characterized by episodes of acute swelling and inflammation. Statistically significant results (DX-88-treated patients versus placebo) were achieved for both the primary and secondary endpoints in the EDEMA3 trial.
The primary endpoint, symptom improvement at four hours measured by a Treatment Outcome Score (TOS) developed for HAE attacks, had a p-value of 0.021. The two secondary endpoints also demonstrated statistical significance. The patient reported assessment of individual symptom burden at four hours measured using the Mean Symptom Complex Severity score (MSCS) had a p-value of 0.024. Time to significant improvement in overall response (defined for this trial as the first time post dosing that the patient reported the symptom complex as "a lot better" or "resolved" within the first 4 hours) had a median time of 149 minutes for the DX-88 group versus greater than 4 hours for the placebo group (p=0.044). The overall safety results showed that DX-88 continues to be well tolerated. There were no drug-related serious adverse events. EDEMA3 is the largest successfully completed, placebo-controlled trial for this indication under a United States Investigational New Drug application.
"We are extremely excited about the outcome of this EDEMA3 trial," commented Henry E. Blair, Chairman and Chief Executive Officer of Dyax. "Based on the topline results of this study, the extensive clinical data collected to date, and the pending completion of the EDEMA4 confirmatory trial already underway, we believe we will be well positioned to apply for regulatory approval to bring to market this much needed therapy for the HAE patient community. The results, which will be presented next week in more detail, highlight the potential of DX-88 to be a safe and efficacious therapy. Ultimately, we believe DX-88 will greatly improve the quality of life of HAE patients worldwide."
EDEMA3 Trial
EDEMA3, the 72-patient, placebo-controlled, multi-center, Phase 3 trial, was conducted at 34 sites in the United States, Europe, Canada, and Israel. The primary objective of EDEMA3 was to determine the efficacy and safety of the fixed 30 mg subcutaneous (SC) dose of DX-88 for patients suffering from moderate to severe acute HAE attacks. The trial had two phases: a double-blind, placebo-controlled phase and a repeat dosing phase. In the first phase, HAE patients received either a single 30 mg SC dose of DX-88 or placebo. After patients received one treatment in the placebo-controlled portion of the study, they were eligible for the second, open-label phase of the study, where they receive repeat dosing with SC DX-88 for any subsequent attacks.
Webcast Presentation Details
Dyax Corp. will host a webcast presentation on Tuesday, April 17, 2007, which will include a discussion of the EDEMA3 results and the patient reported outcome methodology in more detail. Henry E. Blair, Chairman and CEO of Dyax, will be joined by senior management and clinical trial investigators from the EDEMA3 trial.
Date: Tuesday, April 17, 2007
Time: 12:30 p.m. ET
Online Access: Go to the Investor Relations section of the Dyax website (www.dyax.com) and follow instructions for accessing the live webcast. Participants may register in advance.
Telephone Access: Domestic callers, dial 1-888-396-2384
International callers, dial 617-847-8711
Passcode 60760258
A replay of the webcast will be available through May 17, 2007 and may be accessed by dialing 1-888-286-8010. International callers should dial 617-801-6888. The replay passcode for all callers is 25344900. The webcast will be archived on the Dyax website for an indefinite period of time. |
