US-based Arcturus Therapeutics has dosed the first group of participants in the Phase I/II clinical study of its Covid-19 vaccine candidate.
The company said that results from the trial are expected in the fourth quarter of this year.
ARCT-021 is an experimental vaccine, which is being studied with global contract research organisation CTI Clinical Trial and Consulting Services in collaboration with Singapore-based Duke-NUS Medical School. It uses messenger RNA to inoculate against the coronavirus.
In March this year, Arcturus and Duke-NUS collaborated to create a Covid-19 vaccine based on the company’s STARR technology and a Duke-NUS platform designed for the quick screening of vaccines for safety and effectiveness.
The ARCT-021 Phase I/II study comprises two parts. In the Phase I trial, escalating doses will be administered as a single injection to participants aged between 21 and 55.
Based on the results of the safety, immunogenicity, and T-cell response data from this group, dosing regimens will be selected for further evaluation in the Phase II study. This study includes cohorts in younger adults, as well as older adults aged 56-80.
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Arcturus president and CEO Joseph Payne said: “We are very pleased to have initiated dosing in our ARCT-021 Phase I/II study, and in fact we have already completed dosing of all subjects in the first cohort of the study.
“Based on preclinical immunogenicity data, our self-replicating mRNA-based investigational vaccine could have a highly differentiated safety and efficacy profile, and may potentially allow vaccination at very low doses, and with a single administration.
“These favourable attributes could greatly facilitate mass vaccination campaigns necessary to control this global pandemic.”
Last month, Arcturus and Duke-NUS Medical School in Singapore received approval from the country’s Health Sciences Authority (HSA) to assess Covid-19 vaccine candidate LUNAR-COV19 in a Phase I/II clinical trial.