Allakos reports on trials of lirentelimab for atopic dermatitis and chronic spontaneous urticaria
Allakos Inc. a biotechnology company developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, announced topline data from its phase II clinical trial in patients with atopic dermatitis (ATLAS) and from its Phase IIb clinical trial in patients with chronic spontaneous urticaria (MAVERICK)
“We are disappointed that these trials did not meet their primary endpoint, particularly given the need for new treatment options for patients with these severe diseases. Given that neither trial met its primary endpoint, we have decided to not pursue further clinical development of lirentelimab,” said Craig Paterson, M.D., Chief Medical Officer of Allakos. “We express our gratitude to all of the clinical trial investigators, site coordinators and patients in these trials.”
Eosinophils Levels: Consistent with previously reported antibody-dependent cellular cytotoxicity (ADCC) activity of lirentelimab on eosinophils, patients treated with lirentelimab showed sustained depletion of blood eosinophil counts. In the ATLAS trial, lirentelimab-treated patients’ blood eosinophils decreased by 96% versus placebo-treated patients’ blood eosinophils which decreased by 15%. In the MAVERICK trial, lirentelimab-treated patients’ blood eosinophils decreased by 95% versus placebo-treated patients’ blood eosinophils which increased by 9%.
Safety Results: Across both trials safety was similar to previous clinical trials of lirentelimab. The most common adverse events were injection-related reactions (IRRs). In the ATLAS trial, 18.5% of lirentelimab treated patients experienced IRRs versus 6.2% of placebo treated patients. In the MAVERICK trial, 18.2% of lirentelimab treated patients experienced IRRs versus 8.2% of placebo treated patients.
Phase II ATLAS Trial Design; The 14-week, randomized, double-blind, placebo controlled, multicentered trial evaluated the efficacy, safety and tolerability of lirentelimab versus placebo in adult patients with moderate-to-severe atopic dermatitis inadequately controlled by topical medications. 122 patients were randomized 1:1 to receive 300 mg of subcutaneous lirentelimab (n=61) or placebo (n=61) once every two weeks (Q2W).The primary endpoint was the proportion of patients who achieve at least a 75% reduction from baseline in eczema area and severity index (EASI-75) at 14 weeks.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.