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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