The FDA has issued a clinical hold on Altimmune’s IND for its AdCOVID intranasal COVID-19 vaccine candidate, the company said. Altimmune submitted the IND to the agency in November 2020.
According to the company, the FDA requested additional CMC data as well as changes to the protocols, and Altimmune has already responded to the clinical hold letter, which was received on December 22, 2020. The company said that it agreed to all of the requests listed in the letter and that “at this time, does not anticipate a significant impact on the overall clinical development timeline.”
Altimmune President and CEO Vipin K. Garg commented, “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.”
Prior to submitting the IND, Altimmune announced that it had signed a manufacturing agreement with Lonza for AdCOVID.
Read the Altimmune press release.
