Altimmune has submitted an Investigational New Drug (IND) application to the 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, President and CEO 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.”
In a recent pre-IND meeting, the FDA agreed to the overall Phase 1 study design and patient population, as well as plans for manufacturing and product testing of AdCOVID.
The FDA also confirmed that additional nonclinical studies were not required and that the toxicology data previously submitted and reviewed for Altimmune’s NasoShield and NasoVAX intranasal vaccine candidates support the clinical development of AdCOVID, with no additional toxicology studies required before initiation of the Phase 1 trial.