Results of Allakos' multicentre randomised double-blind placebo-controlled Phase 2 trial of Lirentelimab (AK002) in patients with (EG) eosinophilic gastritis and/or (EGE) eosinophilic gastroenteritis (ENIGMA) have been published in the October edition of the New England Journal of Medicine. The poster is available to view here.

Lirentelimab targets the Siglec-8 inhibitory receptor, which is selectively expressed on human mast cells and eosinophils. 

The drug showed clinically meaningful and statistically significant benefits compared to placebo on all pre-specified primary and secondary endpoints, including patients' gastrointestinal tissue eosinophil counts and patient-reported disease symptoms.

Allakos has received orphan drug designation for Lirentelimab for EG, EGE and EoE. There are currently no treatments approved specifically for EG and EGE, which are often misdiagnosed as other gastrointestinal diseases.

A review of the screening data by the study's lead researchers in the American Journal of Gastroenterology demonstrates that there is an underdiagnosis of EG and EGE, diseases which likely have a higher prevalence than what is currently estimated.

Study Details

The Phase 2 trial involved 65 adults across 17 sites in the US with moderate-to-severe symptoms of EGIDs: 10 with a diagnosis of EG, 25 with EGE and 30 with concurrent EG and EGE. Participants were split at random across three arms in a 1:1:1 ratio, each receiving four monthly doses. The first arm received a placebo, the second arm a low dose of Lirentelimab (0.3, 1, 1 and 1 mg per KG), and the third group a higher dose (0.3, 1, 3, 3 mg per KG). In total 43 received the drug, 22 received a placebo.

Primary Endpoint

The primary endpoint was the change in GI eosinophil count from baseline to 2 weeks after the final dose. At day 99, the mean percentage change in the Lirentelimab groups was -86% compared to 9% in the placebo group.

Secondary Endpoint

Secondary endpoints were treatment response (>30% reduction in total symptom score and >75% reduction in gastrointestinal eosinophil count) and the change in total symptom score. Treatment response occurred in 63% of the patients who received the drug and in 5% of the patients who received placebo. The mean change in total symptom score was -48% with the drug and -22% with placebo.

Patients in the Lirentelimab groups also reported greater improvements in all 8 components of the 36-Item Short Form Survey quality-of-life questionnaire.

Links

• Publication in NEJM
• Poster
• ClinicalTrials.gov details
• Allakos press release

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