In a follow-up on the development of Valneva’s Lyme Disease vaccine candidate, VLA15, the company announced today that it is entering Phase 2 Clinical Development.

Borrelia burgdorferi spirochetes/CDC
Borrelia burgdorferi spirochetes/CDC

The overall Phase 2 objective for VLA15 is to determine the optimal dosage level and schedule for use in Phase 3 pivotal field efficacy studies, based on immunogenicity and safety data

The Phase 2 development for the Lyme disease vaccine candidate will include the evaluation of the highest dose of VLA15 tested in Phase 1 in addition to two higher doses. Furthermore, the company plans to include the evaluation of an additional, alternative three-dose schedule

Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva, commented, “Lyme disease cases in the U.S. have increased dramatically over the last 30 years or so, substantially increasing the costs for healthcare systems. The fear of contracting Lyme disease diminishes the quality of life of people of all ages. As the disease footprint widens, the need for a vaccine to prevent this significant unmet medical need increases. Valneva is doing everything possible, in consultation with FDA and EMA, to develop a safe and effective vaccine under the fast track designation.”

The Phase 2 duration is expected to be approximately two years with interim data (primary endpoint) expected mid-2020.