Themis Bioscience, a biopharmaceutical company focused on immunomodulation therapies for infectious diseases and cancer, announced today that the United States Food and Drug Administration (FDA) has granted fast track designation to the Company’s lead vaccine candidate (MV-CHIK) for the prevention of Chikungunya, a debilitating disease with global outbreak potential.
The program is the most advanced Chikungunya vaccine candidate and has already successfully completed Phase 2 clinical development with results recently published in The Lancet. MV-CHIK is the first candidate from Themis’ innovative immunomodulation platform based on the measles vector, one of the safest and most efficacious vaccines available, and has already been tested in over 600 study volunteers in the US, EU and Central America.
“Chikungunya has been identified in over 60 countries across Asia, Africa, Europe and the Americas and remains a major public health concern due to the increased outbreak prevalence,” said Erich Tauber, CEO of Themis Bioscience. “The FDA decision to grant fast track designation to MV-CHIK, recognizes the urgency to prevent this disease and will greatly support our pivotal Phase 3 development efforts this year. It will also allow us to work more closely with the FDA and expedite our efforts to provide a vaccine product to the population as soon as possible.”
The fast track process is designed to facilitate the development and expedite the review of investigational drugs to treat severe conditions and fill an unmet medical need.
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