Vaxart, Inc. (VXRT) announced late Monday that an independent Data Safety Monitoring Board (DSMB), after conducting a scheduled review of 30-day safety data from a select group of 400 participants in its Phase 2b COVID-19 trial, recommended that the study continue without changes.
On the Nasdaq, Vaxart's shares ended Monday’s regular trading session down 8.8%. However, following the announcement, the shares rose 4.1% in after-hours trading.
The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study focusing on evaluating the efficacy, safety, and immunogenicity of Vaxart's oral COVID-19 vaccine candidate. The oral vaccine is being compared to an approved mRNA injectable COVID-19 vaccine in adults previously vaccinated against the infection.
The U.S. Food and Drug Administration (FDA) is currently reviewing the 30-day safety data from the initial group of participants. Vaxart is also seeking approval from the Biomedical Advanced Research and Development Authority (BARDA).
Pending favorable reviews from the FDA and approval from BARDA, the study is set to expand to include approximately 10,000 participants. The trial aims to align its participant demographic with U.S. census data and intends for at least 25% of participants to be over 65 years old.
James Cummings, Vaxart's Chief Medical Officer, stated, “We are pleased with the DSMB's recommendation, marking a crucial step forward in our head-to-head study against an mRNA vaccine. We look forward to the upcoming safety review by the FDA and obtaining BARDA approval so we can proceed to the second phase of our trial, which will assess both safety and efficacy.”
The company indicated that the funding for this initiative was secured under Project NextGen, a $5 billion effort aimed at expediting the development of next-generation COVID-19 vaccines, therapeutics, and enablers.
Vaxart's project is supported through the Rapid Response Partnership Vehicle (RRPV) with a potential value of up to $460.7 million, funded by federal resources.
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