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Novavax Says Primary Endpoints Achieved In Phase II Seasonal Influenza Trial

Novavax Inc. (NVAX) reported positive top-line results from the company's Phase II clinical trial of its quadrivalent seasonal influenza virus-like particle or VLP vaccine candidate. The study's primary objectives of demonstrating safety and immunogenicity of three ascending dose levels of the quadrivalent influenza vaccine were achieved.

The company said that the VLP vaccine candidate demonstrated immunogenicity against all four viral strains based on hemagglutination inhibition assay (HAI) responses at day 21, was also well-tolerated with no vaccine-related serious adverse events observed and reactogenicity was considered acceptable.

A secondary endpoint of the study was to evaluate the potential of the VLP vaccine to fulfill the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research or CBER criteria for accelerated approval.

In adult populations under 65 years of age, these criteria are based on demonstration of seroconversion rates (the proportion of subjects with a four-fold rise in HAI titer or attaining a titer of >=1:40 from a negative baseline) and seroprotection rates (the proportion of subjects with HAI titers >=1:40 post-vaccination) that are >=40% and >=70%, respectively, at the lower 95% confidence bound.

The company noted that the VLP vaccine candidate exceeded protocol design expectations by fulfilling the FDA seroprotection criterion at the lower 95% confidence bound for all four viral strains included. The VLP vaccine candidate also demonstrated the potential to fulfill the FDA seroconversion criterion by demonstrating >=40% seroconversion against three of four viral strains. The fourth virus, B/Brisbane/60/08, despite fulfilling the seroprotection criterion, failed to meet the seroconversion criterion.

The company also announced completion of enrollment of its two Phase I clinical trials to evaluate the safety and immunogenicity of its monovalent VLP A/H5N1 pandemic influenza vaccine comparing two different adjuvanted vaccine candidates with an unadjuvanted vaccine candidate. Top line data from these trials are expected in the fourth quarter of this year.

The company said it is developing both seasonal and pandemic vaccine candidates under a multi-million dollar contract with BARDA, who has been an active partner in planning and evaluating the development of these products.

by RTT Staff Writer

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