Vaxart announced positive topline data from a phase 2 study evaluating the H1 influenza oral tablet vaccine, VXA-A1.1, for the prevention of influenza disease.

The phase 2, double-blind, placebo- and active-controlled study (NCT02918006) included 179 healthy patients aged 18 to 49 years. Patients were randomized 2:2:1 to receive either 1 oral tablet of VXA-A1.1 (n=71), a full intramuscular dose of quadrivalent inactivated influenza vaccine (QIIV [Fluzone Quadrivalent]; n=72), or placebo (n=36). After 90 days post-vaccination, 143 eligible patients were challenged intranasally with a wild-type influenza A H1 virus strain (VXA1.1 [n=58]; QIIV [n=54]; placebo [n=31]). The primary end point was safety, which was assessed in all patients through 365 days, and influenza-positive illness after viral challenge.

Following challenge, 17 (29%) patients in the VXA-A1.1 group were detected to have influenza-positive illness compared with 19 (35%) in the QIIV group and 15 (48%) in the placebo group. Compared with placebo, VXA-A1.1 demonstrated a 39% reduction in clinical disease vs a 27% reduction with QIIV. With regard to safety, VXA-A1.1 was found to be well tolerated; the most common treatment-emergent adverse reaction was headache.

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“These results provide clinical proof-of-concept for Vaxart’s proprietary technology being able to make an oral vaccine that is at least as protective as Sanofi’s Fluzone,” said Sean Tucker, PhD, chief scientific officer of Vaxart. “The results of the clinical study also demonstrated that our oral tablet vaccine primarily protects through mucosal immunity, a potential key factor for improving influenza vaccine performance.”

The Company’s proprietary oral vaccine technology involves altering adenovirus type 5 (Ad5) and using the disabled virus as a vector to carry genes coding for the antigen and the adjuvant to the epithelial cells lining the mucosa of the small bowel.

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