The Singapore Health Sciences Authority approved the continuation of Phase II clinical studies of the ARCT-021 (LUNAR-COV19) vaccine

Arcturus Therapeutics, a leading clinical phase messenger RNA pharmaceutical company, today announced that it has received approval from the Singapore Health Science Authority to conduct Phase II clinical studies on its COVID-19 candidate vaccine ARCT-021.
study will be based on good results from Phase I/II clinical trials and supportive preclinical data.
I/II clinical data from ARCT-021 (LUNAR-COV19) show good tolerance.
immunogenicity was observed in 100% (44/44) patients.
in primate attack models, ARCT-021 (LUNAR-COV19) showed protective effects in both single-dose and primary-exemption-reimmune programmes.
in animals that deplete B cells, ARCT-021 demonstrates protective effects through a single low dose of the drug, further emphasizing the potential importance of ARCT-021 cell immunity.
Phase II study will evaluate single dose and initial rise-boost options for up to 600 participants.
expected to obtain interim phase II clinical data in early 2021.
。