Allakos says 92% of patients achieved complete response in Phase 2 trial

Allakos announced top-line results for the Xolair-naive chronic spontaneous urticaria cohort from its Phase 2 study. The study is being conducted at 4 sites in the U.S. and Germany. The principle investigator is Dr. Marcus Maurer, MD, Professor of Dermatology and Allergy at Charite University in Berlin. The Xolair-naive chronic spontaneous urticaria cohort enrolled 13 patients with uncontrolled urticaria despite treatment with H1 antihistamines at doses of up to 4 times the labeled dosage. Antihistamine medication was maintained throughout the screening period and during the study. Baseline symptom scores, as measured by Urticaria Control Test and Urticaria Activity Score were collected over a 4-week screening period. Patients with baseline UCT scores of less than 12, indicative of poorly controlled urticaria, were enrolled in the study and treated with up to 6 doses of AK002 given once monthly. Patients received an initial dose of 0.3 mg/kg at baseline, followed by a dose of 1.0 mg/kg on day 28, and then received monthly doses of either 1.0 or 3.0 mg/kg for a total of 6 doses. The primary efficacy endpoint was change from baseline in UCT assessed at week 22, two weeks after the last dose of AK002.

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