Final Phase 1 results up to Month 13 confirm the excellent immunogenicity and safety profile for VLA1553, its single-shot vaccine candidate.
Saint Herblain (France), November 18, 2019 – Valneva SE (“Valneva” or “the Company”), member of Atlanpole Biotherapies, a biotech company developing and commercializing vaccines for infectious diseases with major unmet medical needs, today announced excellent final Phase 1 results for its single-shot chikungunya vaccine candidate, VLA1553.
The objectives of the Phase 1 study (VLA1553-101) were to assess the safety and immunogenicity profile of VLA1553 after a single vaccination across three dose levels. Today´s final analysis of the study includes the safety and immunogenicity results up to Month 13 and full results from the “intrinsic human viral challenge.”
The safety profile observed in the prior analysis, announced in May 2019, was confirmed. VLA1553 was generally safe in all dose groups. The low and medium dose groups were well tolerated and showed a superior safety profile, including viremia, compared to the high dose group. No adverse events of special interest (e.g. chikungunya infection related) and no vaccine related Serious Adverse Events (SAEs) were reported up to Month 13. The product candidate´s local tolerability profile was excellent.
Wolfgang Bender, M.D., Ph.D., Chief Medical Officer of Valneva commented, “These fantastic results confirm that VLA1553 is a highly differentiated and promising vaccine candidate that has the potential to address a serious threat to public health. On the basis of all our data, we aim to work with the regulators towards an accelerated approval pathway potentially allowing us to enter directly into pivotal Phase 3 next year.”