Allakos Says Phase 3 Study Of Lirentelimab In EoD Missed Symptomatic Co-primary Goal
(RTTNews) - Biotechnology company Allakos Inc. (ALLK) on Friday reported data from EoDyssey, a 24-week, Phase 3, randomized, double-blind, placebo-controlled study of lirentelimab in patients with biopsy confirmed eosinophilic duodenitis (EoD).
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 3 ENIGMA2 study and excluded certain patients with conditions that could confound the patient reported symptomatic endpoint. Although positive numerical trends in the symptomatic endpoint were observed in this prespecified subpopulation, the results were not statistically significant.
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.
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