Benzinga | Aug 3, 2021 07:04AM EDT

Arcturus Announces Approval Of Singapore Clinical Trial Application To Advance ARCT-154 And ARCT-165, Next Generation STARR mRNA Vaccines Targeting SARS-CoV-2 Variants Of Concern, In A Phase 1/2 Study

Singapore is the second country to approve the advancement of ARCT-154 into clinical development

ARCT-154 and ARCT-165 elicit high levels of neutralizing antibodies in non-human primates against multiple variants of concern

SAN DIEGO--(BUSINESS WIRE)-- Arcturus Therapeutics Holdings Inc. ((the &ldquo, Company&rdquo, , &ldquo, Arcturus&rdquo, , NASDAQ:ARCT), 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, announced today that the Company has received approval for a Clinical Trial Application (CTA) from the Singapore Health Sciences Authority (HSA) to enable the advancement of two STARR(tm) mRNA vaccine candidates into the clinic. The Phase 1/2 clinical trial will evaluate the vaccines both as a primary vaccination series and as a booster following initial vaccination with Comirnaty(r). The Phase 1/2 trial costs are funded in part from a previously secured grant from Singapore.

ARCT-154 and ARCT-165 are next generation STARR(tm) mRNA vaccine candidates targeting current SARS-CoV-2 variants of concern. Preclinical data demonstrated that ARCT-154 and ARCT-165 induce strong neutralizing immunogenicity in non-human primates to SARS-CoV-2 Alpha, Beta, Gamma, and Delta variants. Arcturus also recently announced approval of a CTA for a Phase 1/2/3 clinical trial of ARCT-154 in Vietnam.

"SARS-CoV-2 variants are an increasing public health concern, and we believe that ARCT-154 and ARCT-165 may be well designed to elicit potent immunogenicity to a broad range of emerging variants, including the highly contagious Delta variant. We are pleased to have obtained approval from the Singapore Health Sciences Authority to proceed with the Phase 1/2 clinical trial of ARCT-154 and ARCT-165, and we look forward to the initiation of the trial in Singapore in the coming weeks," said Joseph Payne, President and CEO of Arcturus.