Vaxart completes enrollment in Phase 2b study evaluating its COVID-19 pill

Vaxar announced completion of enrollment of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart’s (VXRT) oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. The sentinel cohort comprised of 400 participants, with 200 receiving Vaxart’s COVID-19 vaccine candidate and 200 receiving an approved mRNA vaccine comparator. “We are pleased to complete the enrollment of the sentinel cohort, an important milestone that reflects the collaboration of our entire team, as well as the trust and commitment of the participants and investigators involved,” said Dr. James F. Cummings, Vaxart’s Chief Medical Officer. “We look forward to DSMB and FDA review followed by the planned initiation of the Phase 2b trial’s second portion. Our continued progress brings us closer to our goal of potentially demonstrating advantages of our mucosal technology against an approved mRNA vaccine.” An independent Data and Safety Monitoring Board DSMB nd the U.S. Food and Drug Administration FDA will review 30-day safety data from the sentinel cohort. Upon favorable review by the DSMB and FDA, the study will progress after Biomedical Advanced Research and Development Authority BARDA approval to the second part of the trial 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. Funding for this award was received under Project NextGen, a $5 B initiative led by BARDA and the National Institute of Allergy and Infectious Diseases NIAID 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 $456M. This project has been funded with federal funds from the U.S. Department of Health and Human Services HHS ; Administration for Strategic Preparedness and Response ASPR ; BARDA, under Other Transaction OT number 75A50123D00005.