Press release
Arcturus Announces Approval of a Clinical Trial Application to Advance ARCT-154, a Next Generation STARR™ mRNA Vaccine Targeting the SARS-CoV-2 Delta Variant and Other Variants of Concern
The Phase 1/2/3 trial to be funded and sponsored by Arcturus’ manufacturing partner Vinbiocare ARCT-154 to be developed in parallel with ARCT-021, Arcturus’
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\nThe Phase 1/2/3 trial to be funded and sponsored by Arcturus’ manufacturing partner Vinbiocare\n\nARCT-154 to be developed in parallel with ARCT-021, Arcturus’ lead investigational COVID-19 vaccine \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, announced today that the company’s partner Vinbiocare has received approval for a Clinical Trial Application (CTA) from the Vietnam Ministry of Health to advance ARCT-154, a next generation Arcturus vaccine targeting SARS-CoV-2 variants of concern, including the Delta variant.\n\nThe ARCT-154 Phase 1/2/3 clinical study is a randomized, observer-blind, placebo-controlled design, and is sponsored and completely funded by Arcturus’ manufacturing partner Vinbiocare – a subsidiary of Vingroup, the largest private industry conglomerate in Vietnam. The study is to assess the safety, immunogenicity and efficacy of the SARS-CoV-2 self-amplifying mRNA vaccine in adults 18 years or older and will enroll up to 21,000 participants across the 3 phases, with 20,000 in Phase 3. Primary endpoints include safety and efficacy with immunogenicity being evaluated in a subgroup. Participants will receive two doses of study vaccine separated by 28 days. Placebo participants will receive active vaccine after 6 months. All participants will be followed up for 1 year. If the clinical trial proves successful at interim evaluations, Emergency Use Approval (EUA) by the Vietnam Ministry of Health is anticipated in December 2021.\n\nPreclinical research demonstrates that non-human primate immunization with ARCT-154 elicits neutralizing antibodies to SARS-CoV-2 variants of concern, including to the widely circulating and highly infectious Delta variant (see table below).\n\n\n\nNeutralizing Antibody Titers to Variants of Concern (Geometric Mean NT50)\n\n\n\n\n\n\nAlpha\n\n\n\nBeta\n\n\n\nGamma\n\n\n\nDelta\n\n\n\n\n\nSTARR™ Vaccine ARCT-154\n\n\n\n9080\n\n\n\n874\n\n\n\n1297\n\n\n\n6876\n\n\n\n\n\nNon-Human primate (NHP) data collected one month after second dose; Analysis of NHP serum was performed using non-replicating vesicular stomatitis virus pseudo-typed with t...