Valneva SE (“Valneva” or “the Company”), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, announced today a further update for its Lyme disease vaccine candidate, VLA15. The Company has successfully concluded the end of Phase 1 process for this candidate with the Food and Drug Administration (FDA) and has obtained alignment with regard to its Phase 2 strategy.
Valneva is now finalizing the detailed Phase 2 protocol and, subject to requisite regulatory approvals, expects to enter Phase 2 clinical development by the end of 2018.
Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva commented “We appreciate the valuable and constructive guidance the FDA has provided and are looking forward to progressing into Phase 2. Lyme is a vaccine preventable disease. We are strongly committed to advancing our Lyme disease vaccine candidate as quickly as possible with the aim of preventing this severe and often debilitating infection.”
The Company will provide a full update on its Lyme program during the publication of its H1 results on August 2nd, 2018.
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