Allakos' Shares Nosedive After Lirentelimab Studies Fail To Achieve Statistical Significance On Symptomatic Endpoints

Allakos' Shares Nosedive After Lirentelimab Studies Fail To Achieve Statistical Significance On Symptomatic Endpoints

Allakos Inc ALLK reported data from ENIGMA 2 Phase 3 study of lirentelimab in eosinophilic gastritis (EG) or eosinophilic duodenitis (EoD) and KRYPTOS Phase 2/3 study of lirentelimab in eosinophilic esophagitis (EoE). 

  • Both ENIGMA 2 and KRYPTOS studies met their histologic co-primary endpoints but did not achieve statistical significance on the patient-reported symptomatic co-primary endpoints.
  • In the ENIGMA 2 Phase 3 trial, the proportion of responders in the lirentelimab arm was 84.6%, versus 4.5% in the placebo arm (p<0.0001).
  • The Absolute mean change in patient-reported Total Symptom Score was -10 versus -11.5 (p=0.343).
  • The proportion of responders in the KRYPTOS Phase 2/3 trial was 87.9% and 92.5% in lirentelimab high dose and low dose arms, compared to 10.9% in the placebo group.
  • Absolute mean change in the patient-reported change in difficulty in swallowing (-17.4, p=0.237), (-11.9, p=0.247) and -14.6.
  • No new safety signals were observed. Mild to moderate infusion-related reactions occurred in 39% of high dose lirentelimab-treated patients, 26% of low dose lirentelimab-treated patients, and 12% of placebo-treated patients.
  • Price action: ALLK shares plunged 87.3% at $10.75 during the premarket session on the last check Wednesday.

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