CORRECTING and REPLACING GRAPHIC Arcturus Reports Strong Three-Month Durability Results from ARCT-154 Booster Trial
Three-month data from ARCT-154 booster trial show persistent neutralizing antibody activity against multiple variants of SARS-CoV-2
International pivotal Phase 3 booster trial preparations initiated with global CRO
Excerpt from the Press Release:
SAN DIEGO–(BUSINESS WIRE)–Please replace the graphic with the accompanying corrected graphic.
The release reads:
ARCTURUS REPORTS STRONG THREE-MONTH DURABILITY RESULTS FROM ARCT-154 BOOSTER TRIAL
Three-month data from ARCT-154 booster trial show persistent neutralizing antibody activity against multiple variants of SARS-CoV-2
International pivotal Phase 3 booster trial preparations initiated with global CRO
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today provided updated data from its Phase 1/2 booster clinical trial showing durability of antibody response with ARCT-154 for at least three months after low-dose (5 mcg) booster.
“We are very pleased to see our self-amplifying mRNA vaccine ARCT-154 demonstrate meaningful and durable increases of neutralizing antibodies against SARS-CoV-2 and variants of concern – for at least three months,” said Joseph Payne, President and CEO of Arcturus Therapeutics. “These results provide additional validation of Arcturus’ next generation STARR™ mRNA technology for vaccines.”
In the ARCT-154 arm of the ongoing Phase 1/2 booster study in the U.S. and Singapore, data from neutralizing antibody assays demonstrate that booster vaccination generated strong immune responses, both with respect to the magnitude of response and duration of response for at least three months post-boost. Twelve participants in this arm received 5 mcg of ARCT-154 at least five months after receiving two primary doses of Comirnaty®. Results from validated pseudovirus microneutralization assay (MNT) to detect responses against the D614G SARS-CoV-2 strain (Figure 1, left) show a single 5 mcg dose of ARCT-154 led to neutralizing antibody responses that remained 30-fold (p =0.007) elevated for geometric mean fold rise (GMFR) over baseline (pre-boost) levels at three months after vaccination. 28-fold and 40-fold increases in neutralizing antibody responses from baseline levels were seen on Day 15 and Day 29, respectively.
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