Data from First Phase 3 Trial (EDEMA3®) for
KALBITOR® (ecallantide) Published in The New
England Journal of Medicine
August 05, 2010 07:03 AM Eastern Daylight Time
CAMBRIDGE, Mass.--(EON: Enhanced Online News)--Dyax Corp. (NASDAQ: DYAX) announced today that
results from EDEMA3®, the Company’s first Phase 3 trial evaluating KALBITOR® (ecallantide) for the treatment
of acute attacks of hereditary angioedema (HAE), were published in the August issue of TheNew England Journal
of Medicine. KALBITOR, discovered and developed by Dyax, is available in the United States for the treatment of
acute attacks of HAE in patients 16 years of age and older.
EDEMA3 was the first of two Phase 3 trials evaluating KALBITOR for the treatment of acute HAE attacks. Results
showed a statistically significant improvement of HAE attack symptoms with KALBITOR treatment versus placebo.
“The KALBITOR clinical program, including EDEMA3 and EDEMA4®, supports the treatment benefit of
KALBITOR for HAE acute attacks,” said H. Henry Li, MD, an author and Director of Immunology at the Institute
for Asthma & Allergy in Wheaton, MD. “Moreover, the publication of these data will enhance understanding among
the physician community about the value of KALBITOR’s unique mechanism of action, as a selective plasma
kallikrein inhibitor, in resolving acute HAE symptoms.”
The overall safety profile of KALBITOR observed in EDEMA3 was similar to that of placebo. The most common
adverse events occurring more often in KALBITOR-treated patients versus placebo were mild or moderate and
included: headache, diarrhea, pyrexia and nasal congestion. Treatment-related adverse events and serious adverse
events occurred at a similar proportion in both the KALBITOR- and placebo-treated groups.
EDEMA3 was a 72-patient, double-blind, placebo-controlled trial randomized 1:1 to receive a 30 mg subcutaneous
dose of KALBITOR or placebo. Patients were observed for at least 4 hours after KALBITOR was administered.
Symptoms were assessed every 15 minut