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news.To resolve symptoms of acute hereditary angioedema attacks in all anatomic locations
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Dyax will present an analysis demonstrating the ability of DX-88 (ecallantide) to resolve symptoms of acute hereditary angioedema (HAE) attacks in all anatomic locations. The analysis will be presented at the American College of Allergy, Asthma and Immunology (ACAAI). The data highlights efficacy and safety analyses from the integrated analysis of the two Phase 3 placebo-controlled trials, EDEMA3 and EDEMA4, of DX-88.
In the time to response to treatment analysis, a statistically significant effect over placebo was achieved with DX-88 for two key endpoints: time to sustained improvement and time to significant improvement.
Marc Riedl, assistant professor of clinical immunology and allergy at the David Geffen School of Medicine, said: “The treatment with DX-88 can potentially offer patients a quick and durable treatment for what is often a debilitating attack that can last for several days if untreated.”
The second presentation provides data on the pediatric experience of DX-88 for treating acute attacks of HAE. A total of 40 acute HAE attacks were treated with subcutaneously-administered DX-88 in 17 pediatric patients. For these patients, individual attack data were compared to the outcomes for the population receiving the corresponding DX-88 dose in the same study.
The data shows symptom improvement, as measured by change in two patient-reported outcomes measures, mean symptom complex severity (MSCS) score and Treatment Outcome Score (TOS) – were better than or equal to that for the reference group in 75% and 78%, respectively, of acute attacks in pediatric patients four hours after treatment with DX-88.
Time to onset of improvement and time to near complete resolution were shorter than or equal to that for the reference group in 58% and 63%, respectively, of acute attacks. There was a low rate of treatment-related adverse events in pediatric patients treated with 30 mg subcutaneous DX-88.
Although hypersensitivity was observed in two pediatric patients treated with intravenous DX-88, no hypersensitivity was observed in the pediatric population following subcutaneous dosing. The efficacy and safety profiles for pediatric patients appeared similar to that of the overall treatment group.