Allakos Inc ALLK has faced a significant setback with the revelation that the 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.
Unfortunately, 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.
Furthermore, 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.
Dr. Craig Paterson, Chief Medical Officer of Allakos, expressed disappointment at these results, emphasizing the pressing need for new treatment options for patients with these severe diseases, and introduced the decision to not pursue further clinical development of lirentelimab.
The disappointing data from the ATLAS trial revealed that lirentelimab-treated patients’ blood eosinophils reduced by 96%, in stark contrast to the marginal 15% reduction in the blood eosinophils of placebo-treated patients.
Similarly, in the MAVERICK trial, lirentelimab-treated patients’ blood eosinophils plummeted by 95% compared to a disturbing 9% increase in the blood eosinophils of placebo-treated patients.
As a response to the disheartening data, Allakos has announced a major restructuring aimed at reducing costs and focusing on AK006 clinical development and additional preclinical programs. The company anticipates that this will extend its cash runway into mid-2026, having ended the fourth quarter of 2023 with approximately $171 million in cash, cash equivalents, and investments.
Consequently, the company will be instituting a series of sweeping measures, including a substantial reduction in its workforce by approximately 50% and a complete cessation of lirentelimab-related activities across clinical, manufacturing, research, and administrative functions.
For Allakos, the financial fallout from this trial failure has been swift and brutal. At last check, ALLK shares were down a jaw-dropping 56.5% at a paltry $1.30, underscoring the severity of the implications.
The company’s decision to discontinue work on lirentelimab in eosinophilic gastrointestinal diseases further compounds the challenges that Allakos is facing.
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