World News: 13:00 GMT Monday 11th February 2019. [Allakos Inc. via Globe Newswire via SPi World News]
REDWOOD CITY, Calif., Feb. 11, 2019 (GLOBE NEWSWIRE) -- Allakos Inc. (NASDAQ: ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell related diseases, today announced positive Phase 2 results for AK002 in patients with Xolair refractory chronic spontaneous urticaria (CSU). The Xolair failure cohort enrolled 11 patients who failed to have an adequate response to prior Xolair treatment. Patients in this cohort had received an average of 10 months of Xolair treatment at doses as high as 600 mg per month. The primary efficacy endpoint was change from baseline in Urticaria Control Test (UCT) assessed at week 22, two weeks after the last dose of AK002.
“The results seen in the Xolair failure cohort are remarkable,” said principal investigator of the study, Dr. Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité University in Berlin. “These patients did not achieve symptom control on Xolair, which is why bringing them into control and significantly reducing their disease activity is a major accomplishment. The results from across cohorts in this Phase 2 study suggest that AK002 could provide a benefit in patients with multiple forms of urticaria, including those refractory to Xolair treatment.”
Robert Alexander, CEO of Allakos, said, “We are very excited by these results because these patients did not respond to Xolair, despite prolonged dosing, and in many cases, at doses higher than indicated on the label. Six of eleven patients reported significant improvements by UCT and the mean decrease in UAS7 was 49 percent. These results, along the with the responses seen in the Xolair naïve, cholinergic and symptomatic dermographism cohorts, suggest that AK002 could be a front-line option for patients with antihistamine refractory urticaria.”
The Xolair failure cohort enrolled 11 patients who failed to have an adequate response to prior Xolair treatment. Patients in this cohort had received an average of 10 months of Xolair treatment at doses as high as 600 mg per month. Patients were required to discontinue Xolair for at least two months before screening but could continue H antihistamines at doses of up to four times the labeled dosage throughout the screening period and study. Baseline symptom scores, as measured by Urticaria Control Test (UCT) and Urticaria Activity Score (UAS7)* were collected over the 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 an initial AK002 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 up to 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 (flushing, feeling of warmth, headache, nausea, and dizziness) which occurred mostly during the first infusion.
Efficacy data from the Xolair failure cohort are presented below; more detailed results from the study will be presented at an upcoming medical conference.
Source: Allakos Inc.
Adam Tomasi, COO, CFO
Globe Newswire: 13:00 GMT Monday 11th February 2019
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