Codagenix's IND application for CodaVax-RSV receives US FDA approval.
M2 EQUITYBITES-June 2, 2022-Codagenix's IND application for CodaVax-RSV receives US FDA approval
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Codagenix Inc., a US-based clinical-stage synthetic biology company, announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for CodaVax-RSV, an intranasal, live-attenuated vaccine candidate, intended to prevent respiratory syncytial virus (RSV) infection in healthy infants and toddlers.
With the approval, the firm is also planning to start a phase one study of vaccine safety and immunogenicity against RSV in healthy children aged six months to five years. This is based on a phase one study of CodaVax-RSV in adults 55-75 years old that achieved its primary safety endpoint and indicated strong anti-RSV-specific cellular immune responses.
J Robert Coleman, co-founder and chief executive officer of Codagenix, said...
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