Pfizer PFE and Valneva SE VALN initiated the Phase 3 VALOR study of its vaccine candidate VLA15 for Lyme disease patients.
The VALOR (Vaccine Against Lyme for Outdoor Recreationists) study is a Phase 3 clinical trial evaluating efficacy, safety and immunogenicity of its vaccine candidate VLA15 in Lyme disease.
The study is planned to enroll approximately 6,000 participants 5 years of age and older at up to 50 sites located in areas where Lyme disease is highly endemic.
The enrolled participants will receive three doses of VLA15 180 µg or saline placebo as a primary vaccination series followed by one booster dose of VLA15 or saline placebo (1:1 ratio).
Annaliesa Anderson, Senior Vice President and Head of Vaccine Research & Development at Pfizer, commented: "With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever, We hope that the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the U.S. and Europe on this important trial."
Pfizer has collaboration agreement with Valneva for the development of VLA15, the company will make a $25 million milestone payment to Valneva upon initiation of the Phase 3 study.
Pfizer is expected to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, based on the outcome of this Phase 3 study.
Price Action : Pfizer shares closed Monday’s trading session at $49.55
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.