After Disappointing Data, Allakos Discontinues Work On Lirentelimab In Eosinophilic Gastrointestinal Diseases

  • Allakos Inc ALLK has reported data from the EoDyssey Phase 3 study of lirentelimab in patients with 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.
  • Although positive numerical trends in the symptomatic endpoint were observed in this prespecified subpopulation, the results were not statistically significant.
  • Related: Allakos' Shares Nosedive After Lirentelimab Studies Fail To Achieve Statistical Significance On Symptomatic Endpoints.
  • The safety results of the trial were generally consistent with previously reported intravenous lirentelimab studies. 
  • Mild to moderate infusion-related reactions occurred in 19.6% of lirentelimab-treated patients and 14.9% of placebo-treated patients.
  • Allakos is not planning to conduct additional studies in eosinophilic gastrointestinal diseases. 
  • The company is focusing on developing lirentelimab in atopic dermatitis and chronic spontaneous urticaria. Topline data from these studies are expected in 2H of 2023. 
  • Additionally, Allakos is advancing AK006 into IND-enabling studies and plans to initiate a Phase 1 study in healthy volunteers in 1H of 2023.
  • Price Action: ALLK shares are down 17% at $3.84 during the premarket session on the last check Friday.
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