Vaxart, Inc. (Nasdaq: VXRT) announced that the independent Data Safety Monitoring Board (DSMB) has recommended that its COVID-19 Phase 2b trial continue without modifications. This decision follows a planned review of the 30-day safety data from a sentinel cohort of 400 participants.
The Phase 2b trial is designed as a double-blind, multi-center, randomized, comparator-controlled study. It aims to evaluate the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate in comparison to an approved mRNA COVID-19 injectable vaccine in adults who have been previously immunized against COVID-19.
Trial Progression and Enrollment
The company plans to advance the trial to enroll approximately 10,000 participants, pending favorable review from the U.S. Food and Drug Administration (FDA) and approval from the Biomedical Advanced Research and Development Authority (BARDA). The trial will aim for a participant demographic that aligns with the U.S. population, including at least 25% of individuals over the age of 65.
Management Commentary
"We are pleased with the DSMB recommendation, an important step forward in conducting our head-to-head study versus an mRNA comparator," said Dr. James F. Cummings, Vaxart's Chief Medical Officer. "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."
Funding and Support
Funding for this project is provided through Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID). This initiative aims to accelerate the development of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award, facilitated through the Rapid Response Partnership Vehicle (RRPV), is valued at up to $460.7 million and is funded by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); and BARDA.
Vaxart's Oral Vaccine Platform
Vaxart is pioneering the development of oral recombinant vaccines using its proprietary delivery platform. These vaccines are designed to be administered as pills, which can be stored and shipped without refrigeration, eliminating the risk of needle-stick injuries. Vaxart believes its oral vaccine delivery platform is suitable for delivering recombinant vaccines, potentially enabling the development of oral versions of existing vaccines and new recombinant vaccines for various indications. The company's development programs include pill vaccines targeting coronavirus, norovirus, and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV).
