Altimmune Submits IND Application For AdCOVID Intranasal COVID-19 Vaccine - Quick Facts

(RTTNews) - Altimmune, Inc. (ALT), a clinical-stage biopharmaceutical company, said Wednesday that it has submitted an Investigational New Drug or 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.

Altimmune noted that the single-dose nasal spray offers greater ease and comfort of administration and positions AdCOVID as a differentiated vaccine candidate for adults and children.

According to the company, AdCOVID is capable of stimulating an additional and specialized type of immunity, local nasal mucosal immunity, that is believed to be critical for preventing further transmission of the virus.

"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. 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," said Vipin Garg, President and Chief Executive Officer of Altimmune.

Altimmune noted that the FDA, in a recent pre-IND meeting, agreed to the overall Phase 1 study design and patient population, as well as plans for manufacturing and product testing of AdCOVID.

Further, the FDA 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.

No additional toxicology studies are required before the start of the Phase 1 trial.