Dyax Announces Treatment of First Patient in Phase 2 Trial of Ecallantide for Acute Treatment of ACE Inhibitor-Induced Angioedema

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ: DYAX) announced today treatment of the first patient in a Phase 2 trial evaluating the efficacy and safety of ecallantide, a potent, selective, reversible inhibitor of plasma kallikrein, for acute treatment of angiotensin converting enzyme (ACE) inhibitor-induced angioedema. This form of angioedema, or rapid swelling of the dermis, mucosa or other tissues, most commonly occurs in the head, face and tongue, and can be severe or life threatening. Ecallantide is 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.

“We believe that ecallantide’s application extends beyond HAE into multiple inflammatory disorders, and our ACE inhibitor-induced angioedema Phase 2 study marks an important step toward realizing this potential”

“ACE inhibitor-induced angioedema is a serious, potentially life threatening inflammatory condition, for which there are no approved treatments,” said Howard Klausner, M.D., associate research director, Department of Emergency Medicine, at the Henry Ford Hospital in Detroit, MI, one of multiple sites involved in the study. “Although this condition is typically treated with standard allergy drugs, these medications are ineffective. Ecallantide could offer benefits in the ACE inhibitor-induced angioedema setting.”

The Phase 2, double-blind, placebo-controlled, randomized trial is expected to compare the safety and effectiveness of conventional therapy treatment plus ecallantide to conventional therapy treatment plus placebo in 176 patients enrolled at 40 U.S. clinical sites. The trial includes four treatment arms (N=44 per arm), three active comparator arms investigating 10 mg, 30 mg and 60 mg subcutaneous doses of ecallantide, and a placebo comparator arm. The primary endpoint is patient discharge from the emergency room by 6 hours post dosing.

“We believe that ecallantide’s application extends beyond HAE into multiple inflammatory disorders, and our ACE inhibitor-induced angioedema Phase 2 study marks an important step toward realizing this potential,” commented Gustav Christensen, President and Chief Executive Officer of Dyax. “It is a sizable, underserved unmet medical need, with an estimated 30,000 cases presenting in the emergency room each year and 10,000 cases requiring hospitalization. We look forward to seeing results of this study, which are currently anticipated in the second half of 2012.”

Ecallantide Mechanism of Action

Ecallantide produces rapid, specific, and reversible blockade of plasma kallikrein, by inhibiting the plasma kallikrein-mediated cleavage of high-molecular weight kininogen (HMWK), directly affecting the pathways involved in both the upstream mediators of bradykinin production as well as the downstream mediators of degradation, thus preventing the release of bradykinin. Stopping extra bradykinin from being released from HMWK through a kallikrein inhibitor combined with the cessation of the ACE inhibitor, should allow the normal degradation pathways to function properly.

About ACE Inhibitor-Induced Angioedema

Angiotensin converting enzyme (ACE) inhibitor-induced angioedema is recognized as being mediated by bradykinin, the metabolism of which is reduced by ACE inhibitors. Angioedema in patients taking ACE inhibitors typically presents without urticaria (chronic hives), whereas cases associated with other medications are likely to present with urticaria. The angioedema most often affects the head, face and tongue, and thus can be life-threatening. Estimates of the frequency of ACE inhibitor-induced angioedema reported in the literature range from 0.1 to 2.2% of patients on ACE inhibitor therapy.

About Dyax

Dyax is a fully integrated biopharmaceutical company focused on discovering, developing and commercializing 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 partnerships to develop and commercialize ecallantide for the treatment of HAE in key regions worldwide. Currently, Dyax has partnership agreements for regions including Europe, Japan, Russia, the Middle East, Israel, North Africa, Australia, New Zealand, Latin America (excluding Mexico), the Caribbean, Taiwan, Singapore and South Korea. The company is also exploring other potential indications for ecallantide, either alone or through partnerships, including drug-induced angioedema and retinal vein occlusion-induced macular edema.

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 as part of its Licensing and Funded Research Program (LFRP), which has approximately 75 revenue generating licenses and collaborations for therapeutic discovery, as well as for affinity separations, diagnostic imaging, and research reagents. The success of the Company’s LFRP royalty portfolio is illustrated by the program’s advanced licensee pipeline that includes 17 candidates in clinical development. Of those candidates, four are in Phase 3 clinical trials, four are in Phase 2 and nine are in Phase 1.

Dyax Disclaimer

This press release contains forward-looking statements, including statements regarding the prospects for therapeutic benefits and treatment advantages of ecallantide. 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 the prospects for therapeutic benefits and treatment advantages of KALBITOR for HAE include the risks that: others may develop technologies or products superior to KALBITOR or that are on the market before KALBITOR; KALBITOR may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the manufacture, marketing, sales and distribution of KALBITOR; 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, the Dyax logo and KALBITOR are registered trademarks of Dyax Corp.