Sep 9, 2022 8:47 am | 1 minute read
- Allakos Inc ALLK has published data from the phase 3 EoDyssey study of lirentelimab in patients with eosinophilic duodenitis (EoD).
- The study met its histological co-primary endpoint, but it did not reach statistical significance on the patient-reported symptomatic co-primary endpoint in both the intent-to-treat (ITT) population and a predefined subpopulation.
- Although positive numerical trends in the symptomatic endpoint were observed in this predefined subpopulation, the results were not statistically significant.
- Related: Allakos shares plummet after lirentelimab trials failed to reach statistical significance on symptomatic endpoints.
- The safety results of the study were generally consistent with previously reported studies of intravenous lirentelimab.
- Mild to moderate infusion-related reactions occurred in 19.6% of lirentelimab-treated patients and 14.9% of placebo-treated patients.
- Allakos does not plan any further studies on eosinophilic gastrointestinal diseases.
- The Company is focused on the development of lirentelimab in atopic dermatitis and chronic spontaneous urticaria. Top-line data from these studies are expected in the second half of 2023.
- In addition, Allakos is advancing AK006 in IND-enabling studies and plans to initiate a Phase 1 study in healthy volunteers in H1 2023.
- Price promotion: ALLK shares are down 17% to $3.84 during the premarket session last Check Friday.
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