Phase III trial results show AK 002 fails to meet primary endpoint in eosinophilic esophagitis.

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 ENIGMA 2, the safety results of the trial were generally consistent with previously reported lirentelimab studies. No new safety signals were observed. Mild to moderate infusion-related reactions (including flushing, feeling of warmth, headache, nausea, and/or dizziness) occurred in 34% of lirentelimab-treated patients and 14% of placebo-treated patients. In KRYPTOS, the safety results of the trial were generally consistent with previously reported lirentelimab studies. No new safety signals were observed.