EoDyssey 24-week phase III trial of AK 002 meets co-primary endpoint in eosinophilic duodenitis

The trial met its histologic co-primary endpoint, but it did not achieve statistical significance on the patient reported symptomatic co-primary endpoint, in both the intent to treat (ITT) population and in a prespecified subpopulation.

The prespecified subpopulation was based on a post hoc analysis of the Company’s phase III ENIGMA2 study and excluded certain patients with conditions that could confound the patient reported symptomatic endpoint (e.g., non-eosinophilic/non-mast cell driven esophageal disorders or active irritable bowel syndrome). Although positive numerical trends in the symptomatic endpoint were observed in this prespecified subpopulation, the results were not statistically significant.

The safety results of the trial were generally consistent with previously reported intravenous lirentelimab studies. Mild to moderate infusion-related reactions (including flushing, feeling of warmth, headache, nausea, and/or dizziness) occurred in 19.6% of lirentelimab-treated patients and 14.9% of placebo-treated patients. Currently Allakos is not planning to conduct additional studies in eosinophilic gastrointestinal diseases, but may do so in the future. Allakos is focusing development efforts for lirentelimab in atopic dermatitis and chronic spontaneous urticaria and on AK006.