Altimmune Inc (NASDAQ:ALT) reported that the U.S. Food and Drug Administration has issued a clinical hold on its Investigational New Drug application for its intranasal COVID-19 vaccine candidate, AdCOVID.
The Gaithersburg, Md.-based company, a clinical-stage biopharmaceutical company, today announced that the Agency requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data.
Altimmune has responded to the Agency’s clinical hold letter received on December 22, and, at this time, does not anticipate a significant impact on the overall clinical development timeline as the Company has agreed to each of the FDA’s requests.
CEO Vipin Garg said, "We appreciate the FDA’s support and guidance as we seek to bring a novel, single-dose intranasal COVID-19 vaccine candidate into the clinic.
"We look forward to working with the FDA and will continue preparing to commence our planned Phase 1 clinical trial of AdCOVID."
AdCOVID is a single-dose intranasal COVID-19 vaccine candidate developed by Altimmune based on the Company’s significant experience in the development of intranasal vaccines for respiratory pathogens. In recently published preclinical studies, conducted in collaboration with the University of Alabama at Birmingham, AdCOVID induced potent serum neutralizing antibody and T cell responses in mice as well as a robust induction in mucosal immunity against the spike protein of the virus that causes COVID-19.
ALT shares dropped 58 cents, or 4.6%, to $12.04.
