Arcturus Therapeutics Receives Approval from Health Sciences Authority to Proceed with Phase 2 Study of Vaccine Candidate | Financial Buzz

Arcturus Therapeutics Receives Approval from Health Sciences Authority to Proceed with Phase 2 Study of Vaccine Candidate

Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) reported approval from the Singapore Health Sciences Authority to commence its Phase 2 clinical study of its vaccine candidate ARCT-021.  The study will utilize its favorable phase ½ study results, including supportive preclinical data.  “We are pleased to advance ARCT-021 into a Phase 2 study based upon our promising Phase 1/2 data, which continues to support the potential for Arcturus’ STARR™ self-replicating mRNA technology to provide a highly effective, and differentiated clinical profile, including a single dose regimen,” said Steve Hughes, M.D., Chief Development Officer of Arcturus. “The Phase 2 study will enable selection of the optimal ARCT-021 vaccination regimen for Phase 3 registrational studies. We look forward to obtaining interim Phase 2 data in early 2021 providing support for the anticipated initiation of a global Phase 3 study in Q2 2021.”

“The Phase 1/2 study results, together with recently generated preclinical data, indicate that ARCT-021 leads to a potent immune response to SARS-CoV-2, and demonstrates a differentiated biological profile whereby the immune response increases in the weeks following vaccination,” said Professor Ooi Eng Eong, Emerging Infectious Diseases Programme, Duke-NUS Medical School and a member of Arcturus’ Vaccine Platform Scientific Advisory Board. “The preclinical finding that ARCT-021 results in protection from SARS-CoV-2, even when humoral immunity is depleted, is particularly notable and suggests that ARCT-021 results in highly potent cellular immunity to the virus. Together, the body of data provides us with confidence that ARCT-021 vaccination will confer substantial protection from SARS-CoV-2 infection and COVID-19.”

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