Therapy Areas: Hereditary Disorders
Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the United States
5 January 2021 - - US-based clinical-stage messenger RNA medicines company Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) has received allowance of the Investigational New Drug application from the US Food and Drug Administration for the Phase 2 clinical study of its vaccine candidate ARCT-021 following review of data from the Phase 1/2 study, the company said.

Arcturus previously announced that the ARCT-021 Phase 2 study had been approved to proceed by the Singapore Health Sciences Authority, who reviewed the same data as reviewed by the FDA.

These Phase 1/2 study results demonstrated favorable tolerability and both humoral and cellular immunogenicity following administration of ARCT-021.

The Phase 2 study will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Both older and younger adult participants will be included.

Early interim analyses of safety and immunogenicity will be performed to inform dose selection for a Phase 3 study, which is targeted to start in 2Q21, if the Phase 2 study is successful.

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' diverse pipeline of RNA therapeutic and vaccine candidates includes self-replicating mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase Deficiency, Cystic Fibrosis, and Cardiovascular Disease along with partnered programs including Glycogen Storage Disease Type 3, Hepatitis B Virus, and non-alcoholic steatohepatitis.

Arcturus' versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics.

Arcturus' technologies are covered by its patent portfolio (205 patents and patent applications, issued in the US, Europe, Japan, China and other countries).
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