Altimmune's AdCOVID Vaccine Gets Positive FDA Update

Altimmune Inc ALT shares are advancing following an update on its coronavirus vaccine program.

What Happened: Maryland-based Altimmune said the FDA has cleared its investigational new drug application for commencing the Phase 1 study of AdCOVID. The company had commenced its vaccine program as early as March 2020.

AdCOVID is a single-dose intranasal vaccine against SARS-CoV-2, the virus that causes COVID-19.

"FDA clearance of the IND marks an important step in developing a safe and effective vaccine designed to stimulate mucosal as well as systemic immunity following intranasal administration," said Vipin Garg, CEO of Altimmune.

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Phase 1 Study Design: The Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy adult volunteers, ages 18 to 55 years.

Volunteers will receive AdCOVID at one of three dose levels administered as a nasal spray.

Why It's Important: Despite three vaccine candidates having already received approval for emergency use, the need for more vaccines effective at emergent strains is acute.

Altimmune said it expects to commence patient enrollment in the Phase 1 clinical trial in the coming week. Data from the study is expected in the coming weeks, it added.

In premarket trading, Altimmune shares were rising 6% to $22.70.