Allakos forced to regroup after mid-stage failures for lirentelimab

16 Jan 2024
firstwordpharma.com
Phase 2Clinical ResultClinical Trial Failure
Allakos will halve its workforce and pivot to focus on an early-stage pipeline candidate after the failure of its lead asset in Phase II studies. “We are disappointed,” remarked chief medical officer Craig Paterson, adding that it will halt work on the mid-stage drug lirentelimab.
The Siglec-8 directed agonist monoclonal antibody, also known as AK002, was being investigated in the ATLAS and MAVERICK trials in atopic dermatitis and chronic spontaneous urticaria, respectively. ATLAS enrolled 122 adults with moderate-to-severe atopic dermatitis inadequately controlled by topical medications, while MAVERICK included 123 adults with moderate-to-severe chronic spontaneous urticaria refractory to antihistamines.
Top-line results from ATLAS showed that 23% of patients treated with lirentelimab achieved the study’s primary endpoint of at least a 75% reduction from baseline in eczema area and severity index (EASI-75) at 14 weeks, which was not significantly more than 18% in the placebo arm.
Meanwhile, headline data from MAVERICK showed that for the main goal, lirentelimab was associated with a 7.9 reduction in the absolute change from baseline in Urticaria Activity Control (UAS)-7 at 12 weeks, which was lower than the 8.4 improvement seen for placebo.
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