Allakos Announces Topline Results from its Phase 1 Trial of AK006 in Patients with Chronic Spontaneous Urticaria and Announces Restructuring

Core Insights - Allakos Inc. has announced the discontinuation of further development of AK006 after it did not demonstrate therapeutic activity in chronic spontaneous urticaria (CSU) [1][2] - The company will reduce its workforce by approximately 75% and explore strategic alternatives [1][8] Clinical Trial Results - In a phase 1 clinical trial, 34 adult patients with moderate-to-severe CSU were enrolled, with 23 receiving AK006 and 11 receiving placebo [2] - The baseline Urticaria Activity Score (UAS7) for AK006 was 34.4 compared to 30.5 for placebo, with a mean change in UAS7 of -8.2 for AK006 and -12.4 for placebo [3] - The complete response rate (UAS7=0) was 9% for both AK006 and placebo groups [3] Safety Profile - AK006 was well-tolerated with no serious adverse events reported; common mild-to-moderate adverse events included headache and infusion-related reactions [4] Financial and Restructuring Actions - The company ended Q4 2024 with approximately $81 million in cash and investments [5] - Estimated restructuring costs to close out AK006 development are between $34 million to $38 million, primarily to be paid in the first and second quarters of 2025 [6] - The company anticipates having cash and equivalents in the range of $35 million to $40 million by June 30, 2025 [6] Workforce Reduction - Allakos plans to retain approximately 15 employees to explore strategic alternatives and maintain compliance with regulatory requirements [8]