Source:

Dellon E, et al. Abstract OP180. Presented at: UEG Week; Oct. 3-5, 2021 (virtual meeting).

Disclosures: Dellon reports serving as an investigator in the ENIGMA study.
October 12, 2021
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Lirentelimab safe, effective in long-term gastritis, duodenitis treatment

Source:

Dellon E, et al. Abstract OP180. Presented at: UEG Week; Oct. 3-5, 2021 (virtual meeting).

Disclosures: Dellon reports serving as an investigator in the ENIGMA study.
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Lirentelimab was safe and effective in the long-term treatment of patients with eosinophilic gastritis and/or eosinophilic duodenitis, according to a presentation at UEG Week.

“Lirentelimab, previously called AK002, is a humanized monoclonal antibody that targets a receptor called siglec-8 that’s highly specific in eosinophils and mast cells. When this receptor is activated, it creates an inhibitory signal that leads to eosinophil depletion and mast cell inhibition,” Evan S. Dellon, MD, MPH, of the University of North Carolina School of Medicine at Chapel Hill, said. “ENIGMA was a phase 2, multicenter, randomized, double blind, placebo-controlled study of lirentelimab (3 mg/kg) in 65 patients with eosinophilic gastritis and/or duodenitis with active moderate to severe symptoms and active eosinophilia on biopsy. Lirentelimab met the primary and secondary endpoints and was well tolerated.”

Among patients dosed with lirentelimab for eosinophilic gastritis and/or eosinophilic duodenitis: 97%; Phase 2 study results revealed lirentelimab reduced gastrointestinal eosinophils by 97% compared with placebo. 75%; Compared with baseline, 26 patients in the open label extension study demonstrated a mean 75% reduction in total symptom score. 100%; According to endoscopy at week 78 in the extension study, 100% of patients achieved histologic remission.

Specifically, phase 2 study results revealed lirentelimab reduced gastrointestinal eosinophils by 97% and total symptom score by 58% compared with placebo.

To investigate the long-term drug safety and efficacy, 58 patients previously enrolled in the ENIGMA study entered the open label extension study and received monthly intravenous doses of lirentelimab on a dose-escalation schedule (0.3 mg/kg or 1 mg/kg escalating to 3 mg/kg). Researchers assessed weekly total symptom scores using electronic daily patient-reported outcome questionnaires and performed upper endoscopy at screening, week 16 of the ENIGMA study, week 30 and week 78 following the first open label dosage. They noted 26 patients completed 94 weeks of lirentelimab treatment as of March 2021.

Compared with baseline, patients demonstrated a mean 75% reduction in total symptom score with a significant decrease among all studied symptoms (abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating and diarrhea). According to endoscopy at week 30 and week 78, 94% and 100% of patients, respectively, achieved histologic remission with no serious drug-related adverse events.

“Long-term treatment with lirentelimab results in sustained histologic and symptomatic improvements in patients with eosinophilic gastritis and duodenitis through week 94. There was also a sustained response of blood and tissue eosinophil depletion and symptomatic responses improved with increased duration of treatment,” Dellon concluded. “Long term treatment with lirentelimab was generally well tolerated; these data support ongoing studies of lirentelimab for eosinophilic GI diseases.”