Allakos Inc.’s AK006 disappointed in a Phase 1 study of chronic spontaneous urticaria (CSU), and the Company will discontinue further clinical development of AK006.
In the CSU cohort, 34 adult patients with moderate-to-severe CSU refractory to antihistamines with or without prior exposure to omalizumab were enrolled and randomized 2:1 to receive 720mg of intravenous AK006 (n=23) or placebo (n=11) once every four weeks (Q4W). Eight of the 34 patients had previously received omalizumab (5 randomized to AK006, 3 randomized to placebo). The primary endpoint of the proof-of-concept cohort was safety and tolerability with therapeutic activity explored using the Urticaria Activity Score (UAS)-7 at 14 weeks.
AK006 was well-tolerated with a favorable safety profile. There were no serious adverse events (SAEs) in subjects on AK006. Adverse events occurring in 2 or more subjects on AK006 were headache (2), infusion related reaction (2), and Covid-19 (2) vs. 1, 0, and 0, respectively, on placebo, all of which were mild-to-moderate in severity.
The Company plans to discontinue AK006-related activities across clinical, manufacturing, research and administrative functions and reduce its workforce by approximately 75%. The Company plans to retain approximately 15 employees to explore strategic alternatives, maintain compliance with regulatory and financial reporting requirements, and wind-down the phase 1 clinical trial.
The Company ended the fourth quarter of 2024 with approximately $81 million in cash, cash equivalents, and investments (unaudited). The Company estimates that cash used in restructuring activities to closeout AK006 development, including severance and contractual payments to vendors, will be approximately $34 million to $38 million. The Company also estimates that a significant majority of these restructuring costs will be paid over the first and second quarters of 2025.
The Company estimates it will have cash, cash equivalents and investments in a range of approximately $35 million to $40 million at June 30, 2025.
