Biotech and vaccine development company, Valneva announced today the initiation of the second study of Phase 2 clinical development for its leading, unique Lyme disease vaccine candidate VLA15.
The overall Phase 2 objectives for VLA15 are to determine the optimal dosage level and vaccination schedule for use in Phase 3 pivotal field efficacy studies, based on immunogenicity and safety data.
Following the Run-In phase for Valneva’s first Phase 2 study VLA15-201, the two lead dosage levels have been selected for further development based on Data and Safety Monitoring Board clearance1.
The objective of the now initiated second Phase 2 study VLA15-202 is to evaluate an alternative immunization schedule for the two lead dosage levels.
Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva, commented, “We are pleased to continue to progress our Lyme vaccine candidate development according to plan and as expeditiously as possible. The disease footprint is widening and the need for a vaccine to prevent this significant unmet medical need is increasing. With higher dosage levels and the potential alternative vaccination schedule, our ultimate goal is to further optimize our vaccine candidate by targeting a high efficacy from the first Lyme season.”
The Phase 2 duration is expected to be approximately two years with initial data (primary endpoint) expected mid-2020.
Valneva’s vaccine candidate, VLA15, is currently the only active vaccine program in clinical development against Lyme disease. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017.
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