Arcturus Therapeutics Holdings Inc. has got the nod from the Ministry of Health to start phase 3b study of ARCT-154 self-replicating RNA vaccine in Vietnam.
|Arcturus Therapeutics has received authorisation to proceed with the clinical testing of ARCT-154 vaccines in Vietnam |
The approval to move forward with the phase 3b portion of the trial was made after an assessment of safety data from the first 1,000 individuals in the ARCT-154 study's phase 1/2/3a cohorts.
ARCT-154 phase 3b study dosing has been initiated and the trial is expected to enrol 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.
“I am very pleased with the progress, including the rapid enrollment and dosing in the ARCT-154 trial. Initiation of dosing in phase 3b portion of the study brings us one step closer to our goal of filing for Emergency Use Authorization (EUA) and making it available as quickly as possible,” said Joseph Payne, president and CEO of Arcturus Therapeutics.
“As a low dose vaccine targeting variants of concern, ARCT-154 has a differentiated profile compared to currently available vaccines and we believe that our programme has the potential to become a best-in-class option for Vietnam and many other countries around the world," he added.
Arcturus Therapeutics is a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases.
In August, Arcturus announced an agreement with Vinbiocare, whereby Vinbiocare will fully fund and establish a facility in Vietnam for the manufacturing of Arcturus’ investigational COVID-19 vaccines. In addition to the $40 million upfront payment, Vinbiocare will purchase the mRNA drug substance from Arcturus and pay a royalty on manufactured doses
With the approval to proceed into phase 3b study for ARCT-154, Arcturus Therapeutics and Vinbiocare remain on track to potentially file an EUA for ARCT-154 in Vietnam in December 2021.