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Altimmune Announces Submission of Investigational New Drug Application for AdCOVID™ a Single-dose Intranasal COVID-19 Vaccine; On Track to Commence Phase 1 Clinical Study in December
Simple, single-dose nasal spray offers greater ease and comfort of administration; positioning AdCOVID as a differentiated vaccine candidate for adults and
About this update from Altimmune, Inc.
[{"type":"text","content":"Simple, single-dose nasal spray offers greater ease and comfort of administration; positioning AdCOVID as a differentiated vaccine candidate for adults and children\n AdCOVID is capable of stimulating an additional and specialized type of immunity – local nasal mucosal immunity – believed to be critical for preventingfurther transmission of the virus GAITHERSBURG, Md., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company advancing proprietary intranasal vaccines and peptide therapeutics, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. AdCOVID is designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA and resident memory T cells) in the nasal cavity and respiratory tract. “We’ve made exceptional progress advancing AdCOVID and are on track to begin a Phase 1 clinical study this year, with a data readout anticipated in the first quarter of 2021,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “While the progress being reported with current vaccines is very encouraging, many in the scientific and medical communities agree that there is continued need for next-generation vaccines that offer significant enhancements. AdCOVID has the potential to provide many benefits not offered by current vaccines, including simple intranasal administration (particularly well-suited for use in children), the ability to be transported at room temperature and conveniently stored in refrigerators for years, and the stimulation of nasal mucosal immunity with the potential to provide sterilizing immunity and block transmission of the SARS-CoV-2 virus. In addition to testing in adults, our IND included a preliminary proposal for evaluation of children as young as 2 years of age, and we look forward to further discussions around our pediatric program with the FDA in the near future.” “It’s not widely known or appreciated that nasal mucosal immunity may be essential in preventing the spread of the SARS-CoV-2 virus to other individuals by stopping replication and transmission of the virus at the site of infection...