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ALLK

Allakos

$57.97 /

+1.66 (+2.95%)

16:09
03/24/20
03/24
16:09
03/24/20
16:09

Allakos announces initiation of three antolimab studies

Allako reported the initiation of three clinical studies of antolimab: a Phase 3 study in eosinophilic gastritis, or EG, and/or eosinophilic duodenitis, or EoD, a Phase 2/3 study in eosinophilic esophagitis, or EoE and a Phase 1 study of subcutaneously administered antolimab in healthy volunteers. 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. The multicenter, randomized, double-blind, placebo-controlled Phase 3 trial will enroll approximately 160 patients with active, biopsy-confirmed EG and/or EoD. Patients will be randomized 1:1 to receive: 1.0 mg/kg of antolimab for the first month followed by five doses of 3.0 mg/kg given monthly, or monthly placebo. The co-primary endpoints of the study are the proportion of patients achieving four eosinophils in 5hpfs in the stomach and/or 15 eosinophils in 3hpfs in the duodenum and absolute change in Total Symptom Score measured using the daily patient reported symptom questionnaire used in ENIGMA. The TSS-6 consists of the six most frequent and severe symptoms reported in ENIGMA. The multicenter, randomized, double-blind, placebo-controlled Phase 2/3 trial will enroll approximately 300 patients with active, biopsy-confirmed EoE. Patients will be randomized 1:1:1 to receive: six antolimab doses of 1.0 mg/kg given monthly, 1.0 mg/kg of antolimab for the first month followed by five doses of 3.0 mg/kg given monthly, or monthly placebo. The co-primary endpoints of the study are the proportion of patients achieving six eosinophils in a single hpf and absolute change in dysphagia symptoms measured using a daily patient reported symptom questionnaire known as the Dysphagia Symptom Questionnaire. The randomized, double-blind, placebo-controlled Phase 1 trial will evaluate the safety, pharmacokinetics, and pharmacodynamics of subcutaneously administered antolimab in healthy volunteers.

ALLK Allakos
$57.97 /

+1.66 (+2.95%)

03/12/20 SMBC Nikko
Allakos initiated with an Underperform at SMBC Nikko
02/27/20 Barclays
Allakos initiated with an Underweight at Barclays
02/27/20 Barclays
Allakos initiated with an Underweight at Barclays
02/04/20 Goldman Sachs
Allakos assumed with a Neutral at Goldman Sachs

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