Allakos Inc ALLK says topline data of lirentelimab from its phase 2 trial in atopic dermatitis (ATLAS) and Phase 2b clinical trial in patients with chronic spontaneous urticaria (MAVERICK) failed to meet the primary endpoints.
In the ATLAS trial, the primary endpoint of the proportion of patients who achieved EASI-75 was 23% for the lirentelimab (n=61) arm compared to 18% for the placebo arm.
In the MAVERICK trial, the change in baseline Urticaria Activity Score (UAS7) was -7.9 (-27%) in the lirentelimab arm versus -8.4 (-26%) in the placebo arm.
“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.
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In the ATLAS trial, lirentelimab-treated patients’ blood eosinophils (a type of white blood cell that protects the body from parasites, allergens, foreign bacteria, and outside organisms) 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%.
With the disappointing data, Allakos announced a restructuring to reduce costs and to focus on AK006 clinical development and additional preclinical programs.
As a result, the company’s cash runway is expected to extend into mid-2026. Allakos ended the fourth quarter of 2023 with approximately $171 million in cash, cash equivalents, and investments.
The company will halt lirentelimab-related activities across clinical, manufacturing, research, and administrative functions, reducing its workforce by approximately 50%.
Related Content: After Disappointing Data, Allakos Discontinues Work On Lirentelimab In Eosinophilic Gastrointestinal Diseases.
Price Action: ALLK shares were down 56.5% at $1.30 at last check Tuesday.
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