Vaxart Announces Last Subject Dosed In Phase 1 Trial Of Its Norovirus Vaccine Candidate In Lactating Mothers

Author: Benzinga Newsdesk | December 21, 2023 09:04am

On track to report topline data by the end of 2024

 

SOUTH SAN FRANCISCO, Calif., Dec. 21, 2023 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT) today announced that it has completed enrollment and dosing in the Phase 1 clinical trial evaluating Vaxart's oral pill bivalent norovirus vaccine candidate focused on lactating mothers.

"This is an important step forward as we drive toward a vaccine candidate that may make it possible for mothers to protect their children against this highly contagious – and potentially lethal -- virus. We look forward to announcing topline data from this study by the end of 2024," said Dr. James F. Cummings, Vaxart's Chief Medical Officer. "We are very proud of our clinical team for completing enrollment of this trial within our planned timeline."

There is no approved vaccine against norovirus, which sickens approximately 21 million people in the United States each year, and 15% of children under age 5 contract norovirus annually. Approximately 3 million sets of parents are forced by this virus to miss work -- approximately 2.2 days on average -- to care for their children. The annual disease burden from norovirus is $10.6 billion in the U.S. alone.

Globally, norovirus has become the leading cause of pediatric gastroenteritis in health care settings in countries that have adopted a rotavirus vaccine program.1 Pediatric deaths in the United States due to norovirus are rare, but they are much more common in the developing world.

About the VXA-NVV-108 Clinical Trial

The Phase 1, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study is designed to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females of at least 18 years of age. The study enrolled 76 subjects at five sites in South Africa. Subjects are randomized into high- or low-dose vaccine (N=30 for each arm) or placebo (N=16). The primary endpoints are:

• Frequency, duration and severity of solicited symptoms of reactogenicity (local and systemic) for one week following study drug dose;
• Frequency, duration and severity of unsolicited treatment-emergent adverse events (TEAEs), serious AEs (SAEs), adverse events of special interest (AESIs) and new onset of chronic illness (NOCIs) through the active period (four weeks post dose);
• Serum VP1-specific (GI.1 and GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last dose);
• Breastmilk VP1-specific (GI.1 and GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last dose).

Further information, including information about study funding, can be found in the Company's press release of December 1, 2022, as well as the Company's latest quarterly filing.

1 Shah and Hall, Infect Dis Clin North Am. 2018 Mar; 32(1): 103-118.

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