Vaxart Announces Favorable DSMB Review To Continue COVID-19 Phase 2b Trial; Stock Up

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(RTTNews) - Vaxart, Inc. (VXRT) announced late Monday that an independent Data Safety Monitoring Board or DSMB, which conducted a planned review of the 30-day safety data from a sentinel cohort of 400 participants in its COVID-19 Phase 2b trial, has recommended to continue the study without any modifications.

On the Nasdaq, Vaxart shares closed Monday's regular trading 8.8% lower. Following the news, the shares gained 4.1% in the after-hours trading.

The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxarts oral pill COVID-19 vaccine candidate. In the trial, it is compared to an approved mRNA COVID-19 injectable vaccine, in adults previously immunized against COVID-19 infection.

The U.S. Food and Drug Administration is reviewing the 30-day safety data from the sentinel cohort. The company also seeks Biomedical Advanced Research and Development Authority or BARDA approval.

Upon favorable FDA review as well as BARDA's approval, the study will progress by enrolling approximately 10,000 participants. The trial will strive to enroll participants in line with U.S. demographics, as well as including at least 25% over the age of 65.

James Cummings, Vaxarts Chief Medical Officer, said, "We are pleased with the DSMB recommendation, an important step forward in conducting our head-to-head study versus an mRNA comparator. We look forward to the next steps of review of the safety data by the FDA and approval from BARDA before advancing the Phase 2b trial to the second part that will measure both safety and efficacy."

The company said the funding for this award was received under Project NextGen, a $5 billion initiative to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers.

Vaxart's project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to $460.7 million. This project has been funded with federal funds.