- Valneva SE (NASDAQ: VALN) completed the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553.
- Valneva posted topline results from the phase 3 trial in August last year. The primary endpoint result is mainly unchanged from that data drop.
- The removal of two subjects from the analysis increased the proportion of participants with protective neutralizing antibody titers from 98.5% to 98.9%, 28 days after receiving a single shot of VLA1553.
- Valneva now also has longer-term immunogenicity data. After six months, 96.3% of the analyzed subjects had protective levels of CHIKV neutralizing antibodies.
- The slight decline between the first and sixth months of the trial still leaves Valneva well above the 70% level of seroprotection it expects the FDA to use as a surrogate of protection.
- Valneva plans to monitor the durability of the antibody response in a subset of participants for at least five years as part of a dedicated persistence trial.
- With topline lot-to-lot manufacturing consistency results for VLA1553 due in Q2, Valneva is now close to gathering the evidence it will need to file for approval in the U.S.
- The plan is to start the pre-submission process with the FDA in the second quarter.
- Suppose Valneva hits that target and avoids any regulatory setbacks. In that case, it should receive a priority review voucher for becoming the first company to win approval for a chikungunya vaccine in the U.S.
- Price Action: VALN shares closed 7.40% at $29 on Tuesday.
Read at Benzinga