BiondVax Pharmaceuticals announced topline data from the Company's pivotal, phase 3 clinical trial of M-001 as a standalone universal flu vaccine candidate.

Results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu illness and severity, and therefore failed to meet both the primary and secondary efficacy endpoints. The study's primary safety endpoint was met.

"We are disappointed with these results, and I wish to thank the BiondVax team for their efforts, dedication, and passion over the past 15 years. Together we have endeavored to develop an innovative approach to a persistent global problem. I am especially grateful to each of the clinical trial participants, as well as the investigators in all our trials for their efforts, and to our stakeholders for their support," said Dr. Ron Babecoff, Founder, President, and Chief Executive Officer. "The significant need for better, more proactive flu protection is well-understood by clinicians and public health experts around the world, and we have devoted many years in pursuit of this worthy goal. Unfortunately, this study did not have the efficacy outcomes that we anticipated for M-001 on a standalone basis. We have observed in seven previous studies that M-001 safely provoked an immune response to a broad range of flu strains, but ultimately this was not sufficient on a standalone basis to show protection."

The randomized, modified double-blind, placebo-controlled, pivotal Phase 3 trial assessed safety and efficacy of the M–001 vaccine candidate alone in reducing flu illness and severity in 12,463 adults aged 50 years and older, including 6,291 (50.5%) aged 65 and older. 4,042 participants were enrolled and randomized in the trial's first cohort prior to the 2018/19 flu season, and an additional 8,421 participants were enrolled across seven Eastern European countries in the trial's second cohort (2019/20 flu season). Each participant was monitored for one flu season.

The trial commenced in 2018, after the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) reviewed the trial design and provided feedback. The CHMP response included comments regarding various aspects of the trial design, and also stated that, "It is agreed that a single pivotal efficacy trial that provides a robust demonstration of efficacy against laboratory-proven influenza like illness (ILI) could suffice for an approval."