BURLINGTON, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ: DYAX) announced today that two poster presentations featuring updated KALBITOR® (ecallantide) data in pediatric patients with hereditary angioedema (HAE) and HAE patients with abdominal attacks were presented at the American College of Allergy, Asthma and Immunology (ACAAI) 2012 Annual Scientific Meeting, held November 8-13, at the Anaheim Convention Center in Anaheim, CA. Both presentations pooled results from patients enrolled in four different clinical trials of ecallantide for the treatment of acute HAE attacks: DX-88/19, an open-label continuation study; EDEMA2®, an open-label, Phase 2 dose-ranging, repeat-dosing study; and EDEMA3® and EDEMA4®, two Phase 3 double-blind, placebo-controlled studies. KALBITOR is indicated for the treatment of acute attacks of HAE in patients 16 years of age and older.
Commenting on the study “Clinical Trial Experience of Pediatric Patients Treated with Ecallantide for Acute Attacks of Hereditary Angioedema,” Andrew MacGinnitie, MD, PhD, Associate Clinical Director, Division of Immunology at Boston Children’s Hospital, and lead investigator of the study, stated: “In order to provide patients with effective relief from the disease’s often debilitating, acute attacks, it is important that pediatric and other specialist communities learn to diagnose and treat HAE as early as possible.”
“Our clinical studies of KALBITOR reinforce its demonstrated ability to effectively treat various patient populations and attack locations,” commented Dr. Burt Adelman, Executive Vice President and Chief Medical Officer at Dyax Corp. “The presentation of these data is part of our ongoing effort to educate the healthcare community about hereditary angioedema and novel treatments such as KALBITOR. Dyax remains committed to providing an HAE support, education and treatment awareness program that is second to none.”
Complete List of Poster Presentations on KALBITOR at ACAAI 2012
Poster Presentations
- Clinical Trial Experience of Pediatric Patients Treated with Ecallantide for Acute Attacks of Hereditary Angioedema – Andrew MacGinnitie, MD, PhD, Associate Clinical Director, Division of Immunology, Boston Children’s Hospital, Boston, MA, Poster P303 presented on Saturday, November 10, 12:30-1:30p.m. PST and Sunday, November 11, 12:00-1:00p.m. PST
- Treatment of Abdominal Attacks of Hereditary Angioedema with Ecallantide – Christopher Stevens, MD, Gastroenterology Medical Consultant, Poster P305 presented on Saturday, November 10, 12:30-1:30p.m. PST and Sunday, November 11, 12:00-1:00p.m. PST
About KALBITOR® (ecallantide)
KALBITOR is
a plasma kallikrein inhibitor indicated for the treatment of acute
attacks of hereditary angioedema (HAE) in patients 16 years of age and
older. KALBITOR, which was discovered and developed by Dyax, is the
first subcutaneous treatment available in the U.S. for treating acute
HAE attacks.
Important KALBITOR Safety Information
Anaphylaxis has been
reported after administration of KALBITOR. Because of the risk of
anaphylaxis, KALBITOR should only be administered by a healthcare
professional with appropriate medical support to manage anaphylaxis and
hereditary angioedema. Healthcare professionals should be aware of the
similarity of symptoms between hypersensitivity reactions and hereditary
angioedema and patients should be monitored closely. KALBITOR should not
be administered to patients with known clinical hypersensitivity to
KALBITOR.
As part of product approval, Dyax has implemented a Risk Evaluation and Mitigation Strategy (REMS) program. The goal of the REMS is to communicate the risk of anaphylaxis and the importance of distinguishing between a hypersensitivity reaction and HAE attack symptoms.
For more information about KALBITOR, including full prescribing information, visit www.KALBITOR.com.
KALBITOR Development HAE Program
The approval of KALBITOR is
based on the results of two placebo-controlled Phase 3 clinical studies,
known as EDEMA3® and EDEMA4®. Patients having an
attack of HAE, at any anatomic location, with at least one moderate or
severe symptom, were treated with 30 mg subcutaneous KALBITOR or
placebo. Because patients could participate in both trials, a total of
143 unique patients participated. There were 64 patients with abdominal
attacks, 55 with peripheral attacks, and 24 with laryngeal attacks. In
both trials, the effects of KALBITOR were evaluated using the Mean
Symptom Complex Severity (MSCS) score and the Treatment Outcome Score
(TOS), two HAE-specific patient-reported outcome endpoints developed by
Dyax. These measures evaluated the severity of attack symptoms at all
anatomical locations (MSCS score) and response to therapy (TOS). In the
EDEMA4 trial at 4 hours, patients treated with KALBITOR demonstrated a
greater decrease from baseline in the mean MSCS than placebo (-0.8 vs.
-0.4; p = 0.010) and a greater mean TOS (53 vs. 8, p = 0.003). In the
EDEMA4 trial at 24 hours, patients treated with KALBITOR also
demonstrated a greater decrease from baseline in the mean MSCS than
placebo (-1.5 vs. -1.1; p = 0.04) and a greater mean TOS (89 vs. 55, p =
0.03). The results in the EDEMA3 trial were consistent with the EDEMA4
trial results.
Potentially serious hypersensitivity including anaphylaxis, have occurred in patients treated with KALBITOR. In 255 HAE patients treated with intravenous or subcutaneous KALBITOR in clinical studies, 10 patients (3.9%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR, 5 patients (2.7%) experienced anaphylaxis. Symptoms associated with these reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension. These reactions occurred within the first hour after dosing.
The most common adverse reactions occurring in greater-than or equal to 3% of KALBITOR-treated patients and greater than placebo were headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis.
KALBITOR Access®
Patients and healthcare
providers can contact KALBITOR
Access® to receive information and work with program
staff to research patient insurance coverage for KALBITOR. KALBITOR
Access is designed as a one-stop point of contact for information about
KALBITOR. The program is staffed with dedicated insurance specialists
and nurse case managers who will help coordinate patient treatment and
access to KALBITOR. Patients and healthcare providers can call
1-888-4KALBITOR (1-888-452-5248) for information and to utilize these
services or visit www.KALBITOR.com.
About HAE
Hereditary angioedema (HAE) is a rare acute
inflammatory condition characterized by episodes of severe, often
painful swelling affecting the extremities, gastrointestinal tract,
genitalia, and larynx. HAE is caused by low or dysfunctional levels of
C1 esterase inhibitor (C1-INH), a naturally occurring molecule that
inhibits plasma kallikrein, a key mediator of inflammation, and other
serine proteases in the blood. HAE is estimated to affect 1 in 10,000 to
1 in 50,000 individuals. Learn more at www.HAEHope.com.
About Dyax
Dyax is a fully integrated biopharmaceutical
company focused on the discovery, development and commercialization of
novel biotherapeutics for unmet medical needs. The Company’s key value
drivers are the KALBITOR® (ecallantide) business and the
angioedema portfolio, as well as the Licensing and Funded Research
Program (LFRP).
Dyax developed KALBITOR on its own and, since February 2010, the Company has been selling it in the United States for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. Outside the United States, the Company has established partnerships to obtain regulatory approval for and commercialization of KALBITOR in certain markets and is evaluating opportunities in others.
The Company is currently developing products to expand its angioedema portfolio, including a diagnostic strategy to identify plasma kallikrein (bradykinin) mediated (PKM) angioedema and a therapeutic candidate, DX-2930, for the prophylactic treatment of PKM angioedema.
KALBITOR and DX-2930 were identified using Dyax’s 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 LFRP. This program has provided the Company a portfolio of product candidates being developed by its licensees, which currently includes 11 royalty and/or milestone bearing product candidates in various stages of clinical development, including three in Phase 3 trials.
Dyax is headquartered in Burlington, Massachusetts. For additional information about Dyax, please visit www.dyax.com.
Dyax Disclaimer
This press release contains forward-looking
statements, including statements regarding the prospects for therapeutic
benefits and treatment advantages of KALBITOR for HAE. 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 products superior to 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 in 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, KALBITOR, KALBITOR Access, EDEMA2, EDEMA3 and EDEMA4 are registered marks of Dyax Corp.