CSL Limited CSLLY and Arcturus Therapeutics ARCT announced the results of a Phase 3 head-to-head study of ARCT-154, a self-amplifying (sa-mRNA) COVID-19 vaccine, compared to Pfizer Inc’s PFE shot Comirnaty.
The study showed that the sa-mRNA COVID-19 vaccine maintained superior immunogenicity compared to the conventional mRNA vaccine Comirnaty for up to one year against Wuhan-Hu-1, Omicron BA.4-5 and certain other variants, and at one-sixth the dose of the comparator (5 μg vs. 30 μg, respectively).
The COVID-19 vaccine from this sa-mRNA platform targeted against the JN.1 variant is approved in Japan for immunization against COVID-19 in adults 18 years and older. It is being sold under the trade name Kostaive.
At Day 29, neutralizing antibodies (GMTs unadjusted) against the Wuhan-Hu-1 strain in ARCT-154 recipients (n = 378) were superior to those in the Comirnaty group (n = 374)
- GMT = 5390 vs. 3738, a GMT ratio of 1.44. This advantage persisted through all time points.
- At Day 361 (unadjusted), GMTs were 3396 and 1771 in ARCT-154 (n = 272) and Comirnaty (n = 266) groups, with a GMT ratio of 1.92.
- Differences were also observed in responses against Omicron BA.4-5, with GMT ratios of 1.31 at Day 29 and 1.89 at Day 361.
Additional data presented by CSL and Arcturus finds that the bivalent formula ARCT-2301, developed on the same platform as ARCT-154, induces superior immunogenicity over conventional bivalent mRNA vaccine Comirnaty, which persists against key variants up to six months postvaccination.
- Data from 930 participants showed that ARCT-2301 (n = 398) induced superior neutralizing antibody responses vs. Comirnaty (n = 405) against Omicron BA.4-5 (GMT ratio 1·49), and against Wuhan-Hu-1 (GMT ratio 1.45).
- The difference persisted through six months with GMT ratios of 2.17 and 1.98, respectively.
- Antibody responses against Omicron XBB.1.5 were also higher after ARCT-2301 vs. Comirnaty.
Price Action: ARCT stock is up 4.70% at $23.07 at last check Monday.
Image via Unsplash
Read Next:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.