Vaxart (NASDAQ:VXRT) reported positive topline data from the dose-ranging Phase 2 clinical trial of its oral pill bivalent norovirus vaccine candidate. Norovirus is the leading cause of acute viral gastroenteritis in all age groups in the U.S. There are no approved vaccines for noroviruses.
The study enrolled 135 healthy adults at three sites in the United States. Preliminary results of the trial showed robust serum immune responses across all doses at day 29 relative to day 1.
Both doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms. The vaccine also was well tolerated, with a favorable safety profile.
“These data, additional forthcoming data from this study, and the data we expect from our norovirus challenge study will help inform our selection of dosage levels in a larger Phase 2b study and support an end-of-Phase 2 meeting with the FDA,” Dr. James Cummings, Vaxart’s CMO, said in a statement.
This is the seventh clinical trial completed in Vaxart’s norovirus program, and it supports previous findings of robust immunogenicity and benign tolerability.
“Our norovirus vaccine candidates are the only ones formulated for oral administration and optimized for delivery to the gastrointestinal system, the site at which norovirus enters the body,” said Andrei Floroiu, Vaxart’s CEO.
