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.