Dyax Announces Treatment of First Patient in Phase 2 Trial of Ecallantide for ACE Inhibitor-Induced Angioedema
Dyax Corp. announced 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.
"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."
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