UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM 8-K
CURRENT
REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of
Report (Date of earliest event reported): June 14, 2012
DYAX
CORP.
(Exact
Name of Registrant as Specified in Charter)
|
Delaware |
000-24537 |
04-3053198 |
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(State or Other Jurisdiction of Incorporation) |
(Commission File Number)
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(IRS Employer Identification No.)
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55 Network Drive |
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(Address of Principal Executive Offices) (Zip Code) |
(617) 225-2500
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
On June 14, 2012, Dyax Corp. issued a press release announcing its decision to discontinue its 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. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Press release of Dyax Corp. dated June 14, 2012.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DYAX CORP. |
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Dated: |
June 14, 2012 | By: |
/s/ George Migausky |
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George Migausky, |
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Executive Vice President and |
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Chief Financial Officer |
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EXHIBIT INDEX
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Exhibit |
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No. |
Description |
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| 99.1 |
Press release of Dyax Corp. dated June 14, 2012. |
4
Exhibit 99.1
Dyax Reports Results of Interim Analysis of Phase 2 Trial of Ecallantide for Acute Treatment of ACE Inhibitor-Induced Angioedema
BURLINGTON, Mass.--(BUSINESS WIRE)--June 14, 2012--Dyax Corp. (NASDAQ: DYAX) announced today the decision to discontinue the Company’s 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 Company’s 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.
“Today’s 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.
About Dyax
Dyax is a fully integrated biopharmaceutical company focused on the development and commercialization of novel biotherapeutics for unmet medical needs. The Company’s lead product, ecallantide, has been approved under the brand name KALBITOR® in the United States for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.
Dyax is commercializing KALBITOR in the United States independently, and establishing strategic collaborations to develop and commercialize ecallantide for the treatment of HAE in key regions worldwide. Currently, Dyax has collaboration agreements for regions including Europe, Japan, Russia, the Middle East, Australia, New Zealand, Latin America (excluding Argentina, Brazil and Mexico) and the Caribbean. The company is also exploring other potential indications for ecallantide, either alone or through collaborations, including drug-induced angioedema.
Ecallantide and other compounds in Dyax’s pipeline were identified 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 through the Licensing and Funded Research Program (LFRP). Collectively, LFRP agreements generate significant revenue for Dyax in the form of license fees, milestone payments and/or royalties. The success of the Company’s LFRP is illustrated by the program’s advanced licensee pipeline that includes 18 candidates in clinical development. Of those candidates, four are in Phase 3 clinical trials, four are in Phase 2 and ten are in Phase 1.
Dyax is headquartered in Burlington, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
CONTACT:
Dyax Corp.
George Migausky, 617-250-5733
Executive
Vice President and
Chief Financial Officer
gmigausky@dyax.com
or
Jennifer
Harsey, 617-250-5741
Manager, Investor Relations and
Corporate
Communications
jharsey@dyax.com