Arcturus Therapeutics announced on Dec. 28 that it received approval from the Singapore Health Sciences Authority to proceed with a Phase 2 clinical study of its vaccine candidate ARCT-021, also known as LUNAR-COV19.
Arcturus (Nasdaq: ARCT) hopes the compound will prove effective as a vaccine against SARS-CoV-2, the virus that causes COVID-19.
The new study will build upon favorable Phase 1/2 study results, as well as supportive preclinical data, Arcturus said in the announcement.
Arcturus specializes in messenger RNA medicines.
“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.”