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     119  0 Kommentare Allakos Initiates Patient Recruitment for AK002 Registrational Studies

    -- Phase 3 study in eosinophilic gastritis and/or eosinophilic duodenitis and Phase 2/3 study in eosinophilic esophagitis --

     -- Top-line safety and efficacy results from both studies expected in the second half of 2021 --

    REDWOOD CITY, Calif., June 03, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell related diseases, today announced that it is recruiting patients for two previously announced registrational clinical studies of AK002; a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Top-line safety and efficacy results from both studies are expected in the second half of 2021. The Phase 3 EG and/or EoD study and the Phase 2/3 EoE study follow positive results from ENIGMA, the Company’s multicenter, randomized, double-blind, placebo-controlled Phase 2 study in patients with EG and/or EoD.

    Phase 3 Eosinophilic Gastritis (EG) and/or Eosinophilic Duodenitis (EoD) Study Design
    The multicenter, randomized, double-blind, placebo-controlled Phase 3 study will enroll approximately 160 patients with active, biopsy-confirmed EG (eosinophil count of ≥30 eosinophils in 5 high powered fields [hpfs] in the stomach) and/or EoD (eosinophil count of ≥30 eosinophils in 3 hpfs in duodenum). Patients will be randomized 1:1 to receive: (a) 1.0 mg/kg of antolimab for the first month followed by five doses of 3.0 mg/kg given monthly, or (b) monthly placebo. The co-primary endpoints of the study are: 1) the proportion of patients achieving ≤ 4 eosinophils in 5 hpfs in the stomach and/or ≤15 eosinophils in 3 hpfs in the duodenum and 2) absolute change in Total Symptom Score (TSS-6: abdominal pain, nausea, bloating, early satiety, abdominal cramping, loss of appetite) measured using the daily patient reported symptom questionnaire used in ENIGMA. The TSS-6 comprises the six most frequent and severe symptoms reported in ENIGMA.

    Phase 2/3 Eosinophilic Esophagitis (EoE) Study Design
    The multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study will enroll approximately 300 patients with active, biopsy-confirmed EoE (eosinophil count of ≥15 eosinophils in a single hpf). Patients will be randomized 1:1:1 to receive: (a) six antolimab doses of 1.0 mg/kg given monthly, (b) 1.0 mg/kg of antolimab for the first month followed by five doses of 3.0 mg/kg given monthly, or (c) monthly placebo. The co-primary endpoints of the study are: (1) the proportion of patients achieving ≤6 eosinophils in a single hpf and (2) absolute change in dysphagia symptoms measured using a daily patient reported symptom questionnaire known as the Dysphagia Symptom Questionnaire (DSQ).

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    Allakos Initiates Patient Recruitment for AK002 Registrational Studies - Phase 3 study in eosinophilic gastritis and/or eosinophilic duodenitis and Phase 2/3 study in eosinophilic esophagitis -  - Top-line safety and efficacy results from both studies expected in the second half of 2021 - REDWOOD CITY, Calif., …