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Therapy Areas: Hereditary Disorders
Arcturus Therapeutics Receives 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
23 September 2021 - - US-based clinical-stage messenger RNA medicines company Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) 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 company said.
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.
The 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.
Founded 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: LUNAR lipid-mediated delivery, STARR mRNA Technology and mRNA drug substance along with drug product manufacturing expertise.
Arcturus' pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase Deficiency, and Cystic Fibrosis along with partnered programs including Glycogen Storage Disease Type 3, Hepatitis B Virus, and non-alcoholic steatohepatitis.
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.
The 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.
Founded 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: LUNAR lipid-mediated delivery, STARR mRNA Technology and mRNA drug substance along with drug product manufacturing expertise.
Arcturus' pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase Deficiency, and Cystic Fibrosis along with partnered programs including Glycogen Storage Disease Type 3, Hepatitis B Virus, and non-alcoholic steatohepatitis.
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