Allakos Inc ALLK has encountered a significant setback, with 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) failing to meet the primary endpoints. This disappointing news has precipitated a plunge in the company’s stock price.
In the ATLAS trial, the proportion of patients who attained EASI-75 was a mere 23% in the lirentelimab arm, compared to 18% for the placebo arm, falling short of expectations.
Similarly, in the MAVERICK trial, the change in baseline Urticaria Activity Score (UAS7) was only -7.9 (-27%) in the lirentelimab arm versus -8.4 (-26%) in the placebo arm, failing to meet the desired criteria.
Expressing disappointment, Dr. Craig Paterson, Chief Medical Officer of Allakos, acknowledged the need for new treatment options and announced the discontinuation of further clinical development of lirentelimab, considering the failure of both trials to meet their primary endpoint.
The trial data also indicates a drastic reduction in blood eosinophils among lirentelimab-treated patients compared to those on placebo. In the ATLAS trial, lirentelimab-treated patients’ blood eosinophils witnessed a staggering 96% decrease, whereas in the MAVERICK trial, the decrease stood at 95%.
Consequently, in response to the disappointing outcomes, Allakos has announced a restructuring plan to curtail costs and prioritize AK006 clinical development and additional preclinical programs. This strategic move is designed to significantly extend the company’s cash runway into mid-2026. At the close of the fourth quarter of 2023, Allakos had approximately $171 million in cash, cash equivalents, and investments.
As part of the restructuring, Allakos will terminate all lirentelimab-related activities across clinical, manufacturing, research, and administrative functions, culminating in a reduction of the workforce by approximately 50%.
In the wake of these developments, ALLK shares were down a staggering 56.5% at $1.30 at last check on Tuesday.
