Press release
Arcturus Therapeutics Announces Approval from Vietnam Ministry of Health to Proceed into Phase 2 and Phase 3a for ARCT-154, Next Generation STARR™ mRNA Vaccine Targeting SARS-CoV-2 Delta Variant and Other Variants of Concern
Phase 1 (100 participants): both doses completed Phase 2 (300 participants) has initiated Phase 3a (600 participants) on track to initiate by end of
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\nPhase 1 (100 participants): both doses completed\n\nPhase 2 (300 participants) has initiated\n\nPhase 3a (600 participants) on track to initiate by end of September\n\nPhase 3b (20,000 participants) dosing planned for first week of October\n\nARCT-154 remains on track for Emergency Use Authorization (EUA) filing in December\n\n SAN DIEGO--(BUSINESS WIRE)--\nArcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, 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, today announced that it has completed dosing of 100 subjects for the Phase 1 portion of the ARCT-154 Phase 1/2/3 clinical trial, which consisted of a two-dose regimen with injections 28 days apart. The Vietnam Ministry of Health has reviewed the safety data following both injections in the Phase 1 part of the study and has given permission to proceed with enrollment of Phase 2 and Phase 3a. Recruitment of these cohorts is now progressing. Emergency Use Authorization filing in Vietnam could be as soon as December 2021.\n\nThe tolerability profile of ARCT-154 in the Phase 1 study was favorable. The Phase 2 and Phase 3a studies will evaluate safety and immunogenicity in an additional 900 subjects in total, and the subsequent Phase 3b will evaluate safety and efficacy in approximately 20,000 subjects.\n\n“We are very pleased, together with our partner Vinbiocare, to have rapidly completed enrollment and dosing of the ARCT-154 Phase 1 study, and to receive approval to proceed into Phase 2/3a. Our goal is to make ARCT-154 available as quickly as possible in Vietnam, as well as many other countries where there remains a high unmet need for effective vaccines against the Delta variant and other variants of concern,” said Joseph Payne, President and CEO of Arcturus.\n\nAbout Arcturus Therapeutics\n\nFounded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine program...