Allakos' lirentelimab disappoints in key research on eosinophilic gastrointestinal disease

Recently, Allakos reported the mixed results of two trials that evaluated the effect of its experimental drug lirentelimab (AK002) in patients with eosinophilic gastrointestinal disease

Phase III ENIGMA 2 study:

The ENIGMA 2 trial enrolled 180 patients with eosinophilic gastritis and/or eosinophilic duodenitis who were randomly assigned to receive intravenous lirentelimab or placebo for 24 weeks

Allakos pointed out that histological resolution is defined as having ≤ 4 eosinophils/high power field (HPF) in the stomachand/or ≤15 eosinophils/HPF in the duodenum, and the second major The end point is to change the six symptoms of abdominal pain, nausea, bloating, early satiety, abdominal cramps, and loss of appetite as measured by the absolute value of self-report

Phase II/III KRYPTOS trial:

The KRYPTOS study included 276 patients with eosinophilic esophagitis who were randomized to receive intravenous lirentelimab or placebo for 24 weeks

In this case, the histological resolution was defined as ≤6 eosinophils/HPF in the esophagus, and the other primary endpoint was measured by evaluating the absolute change in DSQ for dysphagia

Allakos added that in both studies, no new safety signals of lirentelimab were observed.

Original source:

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