In a follow-up on the progress of the Lyme disease vaccine candidate VLA15, French company, Valneva announced today that the U.S. Food and Drug Administration (FDA) has granted the vaccine Fast Track designation.

Borrelia burgdorferi/CDC
Borrelia burgdorferi/CDC

Fast Track designation is granted by the FDA to products that are under development for serious conditions and have the potential to fulfill an unmet medical need. It is designed to facilitate the clinical development and expedite the review of new drugs and vaccines with the intention to accelerate the availability of promising products on the market.

Thomas Lingelbach, President and CEO of Valneva commented, “Lyme disease affects an increasing number of people each year, many of whom have to live with long-term sequelae that are not only extremely difficult to treat but also represent a heavy health economic burden. We feel privileged to advance the only active clinical stage Lyme vaccine candidate to date and are looking forward to working closely with the FDA and other authorities to facilitate the development towards approval.”

Valneva recently completed subject enrollment for the ongoing Phase I study of its Lyme disease vaccine candidate. The study is being conducted at three sites – two in the U.S. and one in Europe (Belgium) – combining approximately 180 subjects aged between 18 and 40 years. The primary objective of the observer-blind, partially randomized, dose escalation study is to evaluate the vaccine candidate´s safety and tolerability profile at different dose levels and formulations.

Immunogenicity, measured by observing IgG antibodies against the six most prevalent serotypes of Lyme borreliosis in the US and Europe present in the vaccine, will also be monitored for different dose groups and formulations at different time-points.

Given the steady increase in the incidence of the disease and its spread to new territories, Valneva is committed to accelerate the development of VLA15 as a novel prevention against such a high priority medical need. As such, the company plans to initiate Phase II as early as the first quarter of 2018.

Pre-clinical data showed that Valneva’s vaccine candidate had the potential to provide protection against the majority of Borrelia species pathogenic for humans.