Arcturus Therapeutics Announces Approval from Vietnam Ministry of Health to Proceed into Phase 3b Study for ARCT-154, a Next Generation STARR™ mRNA Vaccine Targeting SARS-CoV-2 Delta Variant and Other Variants of Concern
- Phase 3b dosing of ARCT-154 initiated; study designed to enroll approximately 20,000 participants
- Initiation of Phase 3b study follows review of safety data from initial 1,000 Phase 1/2/3a participants
- ARCT-154 remains on track for Emergency Use Authorization (EUA) filing in
ARCT-154 Phase 3b study dosing has been initiated and the trial is expected to enroll approximately 20,000 participants with half of the participants receiving ARCT-154 under a two-dose regimen with injections 28 days apart, while the other half will receive placebo. The Phase 1 part of the trial has completed the priming vaccination series with two administrations in 100 participants (75 in ARCT-154 arm). The Phase 2 and Phase 3a parts of the trial are ongoing with 300 (225 in ARCT-154 arm) and 600 (450 in ARCT-154 arm) participants, respectively.
The approval to proceed with the Phase 3b portion of the study follows the review of safety data from the initial 1,000 participants included in the Phase 1/2/3a cohorts of the ARCT-154 study.
“I am very pleased with the progress, including the rapid enrollment and dosing in the ARCT-154 trial. Initiation of dosing in the Phase 3b portion of the study brings us one step closer to our goal of filing for EUA and making it available as quickly as possible,” said
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