- Target enrollment of 2,850 healthy volunteers completed across multiple European countries
- Topline data read-out expected by mid-2026, subject to influenza circulation during the winter season
Lyon, France and Liège, Belgium – December 09, 2025 – Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced the completion of enrollment in its Phase 2b clinical trial, known as Asuniva (NCT05569239), evaluating OVX836, the company’s broad-spectrum influenza A vaccine candidate. The study was initiated prior to the onset of the flu season to ensure optimal follow-up during the natural circulation period of influenza, enabling the generation of robust efficacy data.
“Completing enrollment is a significant achievement for our influenza program and positions us to collect comprehensive efficacy data during the 2025-2026 flu season,” commented Dr. Nicola Groth, Chief Medical Officer of Osivax. “We would like to thank all participants, investigators, and clinical teams for their dedication and contributions, which have been critical to achieving this milestone.”
“Reaching the full enrollment target in this Phase 2b trial marks another major step toward our goal of developing broad-spectrum influenza vaccines that can address the global burden of influenza,” added Alexandre Le Vert, CEO & Co-Founder of Osivax. “We are eager to progress toward key readouts in 2026 and look forward to the next stage of development for OVX836.”
Osivax anticipates announcing topline results following completion of participant follow-up, data cleaning and analysis in mid-2026, depending on influenza circulation during the 2025-2026 winter season.
About OVX836
OVX836 is a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response. Osivax’ oligoDOMTM technology enables the design and production of a recombinant version of the NP, which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses. OVX836 has been tested in 7 clinical trials with over 1,400 participants so far, and has shown promising safety, immunogenicity, and efficacy read-outs.
About OVX836-005 – Asuniva
Asuniva is a randomized, double-blind, placebo-controlled, multicenter Phase 2b trial conducted in Belgium, France, Finland and Germany, to assess the safety, immunogenicity, and efficacy of a single intramuscular dose of OVX836 (480 µg) in 2,850 participants aged 18–59 years. Asuniva is the first large, efficacy-powered study of OVX836 and is designed to generate the clinical evidence needed to advance the vaccine toward late-stage development. Further information can be found at clinicaltrials.gov.
About Osivax
Osivax is a clinical-stage biopharmaceutical company developing a portfolio of differentiated influenza vaccines generating superior T-cell responses in addition to strong and sustained B-cell responses, thanks to its novel, self-assembling nanoparticle platform technology, oligoDOMTM. The company’s lead candidate, OVX836, is a broad-spectrum influenza A vaccine candidate currently in Phase 2b clinical trials with over 1,400 volunteers tested and encouraging efficacy proof of concept data. By combining OVX836 with standard flu vaccines, Osivax is advancing toward a best-in-class seasonal flu vaccine to prevent all strains of influenza. Osivax collaborates with leading global health agencies, including US-based BARDA and NIH, and European-based institutions and top-tier pharmaceutical companies, reinforcing its mission to prevent all types of seasonal and pandemic influenza. The company will expand into other infectious disease indications through combinations and collaborations worldwide.
For further information: www.osivax.com
Contact
Alexandre LE VERT, CEO
contact@osivax.com
+33 (0)9 70 30 13 80
For Media Inquiries
Trophic Communications
Anja Heuer
osivax@trophic.eu
+49 (0) 151 106 199 05
