Allakos announces results from two cohorts of Phase 2 AK002 trial

Allakos announced “positive” Phase 2 results from two additional chronic urticaria cohorts: patients with cholinergic urticaria and symptomatic dermographism. Earlier this month, Allakos reported that 12 of 13 patients in the Xolair-naive chronic spontaneous urticaria, or CSU, cohort achieved a complete response with AK002. Top-line results for the remaining urticaria cohort, patients with chronic spontaneous urticaria who failed to respond to Xolair, are expected later in Q1. The study is being conducted at four sites in the U.S. and Germany. The cholinergic urticaria and symptomatic dermographism cohorts enrolled 11 and 10 patients, respectively, with uncontrolled urticaria despite treatment with H1 antihistamines at doses of up to four times the labeled antihistamine dosage. Antihistamine medication was maintained throughout the screening period and during the study. Baseline symptom scores, as measured by Urticaria Control Test, or UCT, 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 six 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, depending on response, for a total of six doses. The primary efficacy endpoint was change from baseline in UCT assessed at week 22, two weeks after the last dose of AK002. AK002 was generally well tolerated. The most common adverse event was mild to moderate infusion-related reactions which occurred mostly during the first infusion.

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