Codagenix announced that it has initiated a Phase 1 study of its CodaVax-RSV live-attenuated intranasal vaccine candidate in children aged 6 months to 5 years, with the study expected to enroll 18 children aged 2 to 5 years and 33 children aged less than 2 years. The FDA cleared an IND for the study in mid-2022. A previous Phase 1 study evaluated the nasal spray in adults up to age 75.
In November 2022, the company announced that the FDA had granted Fast Track designation designation to CodaVax-RSV. Earlier this year, Codagenix said that it had raised $25 million for development of the RSV vaccine.
Codagenix CEO J. Robert Coleman commented, “Codagenix is focused on providing an effective prophylactic vaccine for infants and toddlers 6 months to 5 years old who, based on the recent data, may be at higher risk for hospitalization following infection despite recent innovations in other RSV vaccines for the elderly that are under review. As a live-attenuated, intranasal vaccine designed using our differentiated codon deoptimization platform, CodaVax-RSV is particularly well positioned to address this significant unmet need since it has the potential to induce innate immunity and durable local and systemic immunity. We look forward to advancing this important clinical study as we work to deliver a vaccine capable of protecting this at-risk patient population.”
Read the Codagenix press release.
