Allakos announces results from its Phase 1 trial of AK006

Allakos (ALLK) announced topline results from its phase 1 clinical trial of AK006 in chronic spontaneous urticaria. 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 720 mg of intravenous AK006 or placebo once every four weeks. Eight of the 34 patients had previously received omalizumab. The primary endpoint of the proof-of-concept cohort was safety and tolerability with therapeutic activity explored using the Urticaria Activity Score-7 at 14 weeks. AK006 was well-tolerated with a favorable safety profile. There were no serious adverse events in subjects on AK006. Adverse events occurring in 2 or more subjects on AK006 were headache, infusion related reaction, and Covid-19 vs. 1, 0, and 0, respectively, on placebo, all of which were mild-to-moderate in severity.