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| KALBITOR(R) (ecallantide) Data Presented at American Academy of Allergy, Asthma and Immunology Annual Meeting |
Results of KALBITOR Efficacy for HAE Acute Attacks by Attack Location CAMBRIDGE, Mass., Mar 02, 2010 (BUSINESS WIRE) -- Datademonstrating the effectiveness of KALBITOR (ecallantide) to treat hereditary angioedema (HAE) acute attacks by primary attack location were provided in an oral presentation yesterday at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2010 Annual Meeting in New Orleans. KALBITOR, discovered and developed by Dyax Corp. (NASDAQ:DYAX), was approved by the U.S. Food and Drug Administration (FDA) late last year and is indicated for the treatment of acute attacks of HAE in patients 16 years of age or older. Efficacy endpoints assessed at 4 hours post-dosing for peripheral, abdominal and laryngeal attacks included two, HAE-specific, patient-reported outcome measures: Mean Symptom Complex Severity (MSCS) score and Treatment Outcome Score (TOS). Time to significant improvement was also assessed at 4 hours. "HAE is a complex disease with varying anatomic locations affected during each acute attack. By stratifying the data by attack location, we were able to discern the effect of treatment during each episode at each affected location," stated Patrick Horn, MD, PhD, Vice President of Clinical and Medical Affairs at Dyax Corp. and one of the study authors. Statistically significant improvement of symptoms, when analyzed by attack location, was demonstrated with KALBITOR treatment versus placebo based on TOS at 4 hours (peripheral: P=0.035, abdominal: P=0.026, laryngeal: P=0.041). For change in MSCS score at 4 hours, KALBITOR treatment also showed statistically significant improvement over placebo for abdominal attacks (P=0.001) and a clinically meaningful improvement for peripheral attacks. Clinically meaningful improvement is based on the Minimally Important Difference (MID), the smallest difference in a score that is considered to be meaningful or important, (-0.30 points for change from baseline in MSCS score at 4 hours post-dosing). Small sample sizes prevented a statistically meaningful comparison for laryngeal attacks. In time to complete or near-complete symptom resolution, KALBITOR treatment was significantly better than placebo for abdominal (P=0.011) and laryngeal (P=0.033) acute attacks. "There was a striking difference between ecallantide and placebo in the time to complete or near-complete symptom resolution for the abdominal and laryngeal specific attack locations," noted Marc Riedl, MD, MS, Assistant Professor of Clinical Immunology and Allergy at the David Geffen School of Medicine at UCLA in Los Angeles, and a study investigator. "Importantly, time to complete or near-complete symptom resolution for abdominal and laryngeal attacks was reached by 4 hours for 65.2 % and 60.0% of ecallantide-treated patients versus 31.7% and 11.1% of placebo-treated patients, respectively." A total of 143 patients from the EDEMA3 double blind and EDEMA4 studies were included in this analysis (N=70 KALBITOR, N=73 Placebo). Distribution by attack location was as follows: abdominal: N=23 KALBITOR, N= 41 placebo; peripheral: N=32 KALBITOR, N= 23 placebo; laryngeal: N=15 KALBITOR, N= 9 placebo. The most common treatment emergent adverse events in ecallantide-treated HAE patients were headache, fatigue, nausea, upper respiratory tract infection and dizziness. Adverse events were similar across attack locations. There were no reports of hypersensitivity, including anaphylaxis in this population. As part of product approval, Dyax has implemented a Risk Evaluation and Mitigation Strategy (REMS) program, consisting of a Medication Guide and communication plan. 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. Also presented at AAAAI were three poster presentations highlighting KALBITOR efficacy and safety information from Dyax's HAE clinical development program, which included results from the Company's two placebo-controlled Phase 3 trials, known as EDEMA3(R) and EDEMA4(R), and the first-time presentation of data from the ongoing open-label, continuation study. Complete List of Presentations at AAAAI 2010 Oral Presentations
Poster Presentations
About KALBITOR(R)(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. 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(R) and EDEMA4(R). 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 reactions, 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 AccessSM Patients and healthcare providers can contact KALBITOR AccessSM 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 http://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, the gastrointestinal tract, the genitalia, and in the 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 1:10,000 to 1:50,000 individuals. About Dyax Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax's first product, KALBITOR(R) (ecallantide), is approved in the United States for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older. Dyax's lead product candidate is DX-88, a recombinant, small protein that is being evaluated for its therapeutic potential in other angioedema indications (acquired and ACE inhibitor-induced angioedemas). Additional DX-88 indications are being evaluated through Dyax's partners: Cubist Pharmaceuticals is in Phase 2 for the reduction of blood loss during on-pump cardiac surgery and Fovea Pharmaceuticals (sanofi aventis) is in a Phase 1 trial for retinal vein occlusion induced macular edema. DX-88 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 with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents. Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit http://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 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 and EDEMA3 and EDEMA4 are registered service marks of Dyax Corp. KALBITOR Access is a service mark of Dyax Corp. SOURCE: Dyax Corp. Dyax Corp. |
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