Benzinga | Aug 5, 2021 06:48AM EDT

Valneva's Chikungunya Vaccine Candidate Shows Protective Neutralizing Antibodies In Late-Stage Trial

* Valneva SE (NASDAQ:VALN) has announced positive topline results from the Phase 3 trial evaluating its single-shot chikungunya vaccine candidate in around 4,100 adults. Chikungunya is a mosquito-borne viral disease.

* Dubbed VLA1553, the vaccine candidate met its primary endpoint inducing protective chikungunya virus (CHIKV) neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot.

* The seroprotection rate result of 98.5% exceeded the 70% threshold (for non-acceptance) agreed with the FDA.

* Additionally, VLA1553 was also highly immunogenic in elderly study participants, who achieved equally high seroprotection rates and neutralizing antibody titers as younger adults and a similar good safety profile. VLA1553 was generally well tolerated.

* The majority of solicited adverse events were mild or moderate and resolved within 3 days.

* 1.6% of study participants reported severe solicited adverse events, most commonly fever.

* The trial will continue towards the final analysis, including the 6-month safety data. The sponsor of the first chikungunya vaccine approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV).

* The FDA awarded the candidate Breakthrough Therapy Designation in July 2021.

* Price Action: VALN shares closed at $28.39 on Wednesday.