Dyax Corp. (NASDAQ: DYAX) today announced the presentation of data from KALBITOR® (ecallantide) clinical studies in hereditary angioedema (HAE) at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in Orlando, Florida. The data were presented in four separate poster presentations and included data related to rebound and relapse rates in patients treated with KALBITOR as well as to KALBITOR for the treatment of acute laryngeal attacks of HAE. KALBITOR is indicated for the treatment of acute attacks of HAE in patients 16 years of age and older.
“Taken together, the results presented today enrich the KALBITOR efficacy profile and provide further support for its use against acute attacks of HAE,” stated Henry Li, M.D., Ph.D. of the Institute for Asthma and Allergy in Wheaton, MD. “Notably, low rebound and relapse rates observed among patients treated with KALBITOR evidence sustained relief from HAE attacks, an important consideration in selecting therapy.”
Albert L. Sheffer, II, M.D. of the Brigham and Women’s Hospital in Boston, MA, added: “Among the findings of our multi-study evaluation are data demonstrating that treatment with KALBITOR produced clinically meaningful and sustained improvement in laryngeal attacks due to HAE. The larynx is the most serious HAE attack site, and laryngeal attacks will affect nearly half of all individuals with HAE at least once during their lifetime. The availability of an on-demand treatment such as KALBITOR is, therefore, a valuable part of the individual patient’s treatment plan.”
“The KALBITOR studies presented demonstrate Dyax’s ongoing commitment to HAE,” stated Gustav Christensen, President and Chief Executive Officer at Dyax Corp. “We remain focused on educating the HAE community about the benefits of treatment with KALBITOR, ensuring access to this important therapy, and evolving our plasma kallikrein (bradykinin) mediated angioedema franchise with investments in next-generation products and services.”In the poster presentation titled, “Rates of Rebound or Relapse Among Acute Attacks of Hereditary Angioedema Treated with Ecallantide in Open-Label, Repeat-Treatment Study,” Dr. Li determined that the rates of rebound and relapse were low among patients treated with KALBITOR. In the study, 144 HAE patients were monitored following treatment with KALBITOR and evaluated using three assessments: the Treatment Outcome Score (TOS), Mean Symptom Complex Severity (MSCS) score, and global response assessment. Treatment episodes showing improvement in all three assessments at 4 hours after dosing, followed by worsening in any assessment at 24 hours were identified as potential cases for further characterization. Rebound was defined as worsening beyond baseline, while relapse was defined as worsening but not beyond baseline. Of the 340 treated attacks with improvement in all three assessments at 4 hours and with data available at 24 hours, 58 were identified as potential cases for further characterization. These cases were then characterized as likely, possible, or unlikely based on number of assessments showing worsening and the quantitative magnitude of change in each assessment. Of the 338 treated attacks in this analysis:
- 3 (1%) treated attacks were identified as likely rebound and 8 (2%) as likely relapse;
- 0 (0%) treated attacks were identified as possible rebound and 12 (4%) as possible relapse; and
- 0 (0%) treated attacks were identified as unlikely rebound and 35 (10%) as unlikely relapse.
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