Allakos has announced a 75% workforce reduction and the discontinuation of its chronic spontaneous urticaria (CSU) AK006 development programme following underwhelming Phase I results.
This decision will leave the US biotech with approximately 15 employees as it evaluates “strategic alternatives” and concludes its trial activities.
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The Phase I trial for AK006 (NCT06072157), which enrolled 34 adults with moderate-to-severe CSU – also known as chronic hives—compared the drug to a placebo. Participants in the AK006 group had a baseline score of 34.4 on a 42-point disease severity scale, which dropped by 8.2 points after treatment. By contrast, the placebo group saw a larger improvement, with scores dropping 12.4 points from a baseline of 30.5. The proportion of complete responses was the same in each arm at 9%.
This is not the first setback for Allakos in addressing CSU. In January 2024, the company halted the development of the previous lead candidate lirentelimab. This came after its failure in two Phase II studies for atopic dermatitis and CSU. These trials also fell short of primary endpoints, with lirentelimab failing to demonstrate statistical significance compared to placebo in improving disease activity scores. Following this failure, Allakos cut its workforce by 50% and shifted its focus to AK006 and other preclinical programmes.
This latest workforce reduction and programme discontinuation comes with significant financial implications. Allakos ended last year with $81m in cash reserves but expects restructuring costs, including severance payments, to amount to $34m to $38m. By mid-2025, the company projects its cash reserves will be reduced to $35m to $40m. This financial pressure adds urgency to its search for alternative paths forward.
CSU is a skin condition characterised by red, itchy, and painful hives lasting six weeks or longer. Unlike allergen-induced conditions, CSU is driven by immune system responses and is typically managed symptomatically with antihistamines, antipruritic, and anti-inflammatory treatments.
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By GlobalDataWhile Allakos has exited the CSU drug development space, other companies continue to pursue therapies. Novartis, for example, is advancing its CSU candidate remibrutinib through regulatory submissions after positive data from two Phase III studies (NCT05030311 and NCT05032157). At the 2025 JP Morgan Healthcare conference in San Francisco on 14 January, Novartis said it expects remibrutinib to be one of its drugs that drives growth in the 2030s.
Remibrutinib is projected to generate $1.2bn in sales by 2030, according to GlobalData’s Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
