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Medivir’s partner Vetbiolix announces initiation of randomized, placebo-controlled study to confirm clinical benefit with VBX-1000 (MIV-701)

  • Speedy inclusion of the first 10 dogs, out of a total of 51, within one month of study start
  • Top-line data expected by Q4 2026
  • Blockbuster potential as the first disease-modifying therapy to halt bone loss in canine periodontitis

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments in areas of high unmet medical need, announced today that its partner Vetbiolix, a France-based veterinary biotechnology company, has initiated First Patient First Visit in a pilot randomized, double-blind, placebo-controlled, dose-ranging clinical study evaluating VBX-1000 (MIV-701) for efficacy and safety in dogs with alveolar bone loss due to Stage 2–3 periodontitis.
 
The primary objective of the study is to confirm the Landmark Proof-of-Concept clinical study results published in November 2025 by comparing VBX-1000 (MIV-701) with placebo in reducing clinical attachment loss in dogs with stage 2 or 3 periodontal disease and alveolar bone loss, over a 90-day treatment period. Eligible dogs will be randomized in a 1:1:1 ratio to one of three treatment groups:
 

  • Dose 1 (n≈17): VBX-1000 (MIV-701) at 15 mg/kg/day, administered orally once daily as capsules.
  • Dose 2 (n≈17): VBX-1000 (MIV-701) at 45 mg/kg/day, administered orally once daily as capsules.
  • Placebo (n≈17): Matching placebo capsules, administered orally once daily.

 
- “The inclusion of the first patients is a crucial step for our team. We are confident, considering exciting clinical data recently published in Frontiers in Veterinary Science (https://www.frontiersin.org/journals/veterinary-science/articles/10.3389/fvets.2025.1656782/full), that VBX-1000 (MIV-701) will significantly improve the management of canine periodontitis, a condition for which there is currently no therapeutic treatment other than surgery. The strong involvement of clinicians specializing in veterinary dentistry in the set-up of our clinical study, and now in active recruitment of dogs patients, demonstrates the significant expectation of the veterinary community and pet owners for a better management of periodontitis” says Matthieu Dubruque, Founder and Managing Director of Vetbiolix.
 
- Jens Lindberg, CEO of Medivir: “VBX-1000 (MIV-701) is potentially the first and only disease-modifying drug for periodontal disease in dogs, a condition affecting 80% of the population over three years of age. A positive outcome of this clinical study could position VBX-1000 (MIV-701) as a blockbuster candidate with significant value potential for Medivir shareholders. We are impressed by the speed and quality of the Vetbiolix team’s work and look forward to the top-line results expected by Q4 2026.”
 
Under the agreement with Vetbiolix, Medivir retains substantial revenue upside through future royalties on net sales and a meaningful share of any partnering payments from third-party collaborations. Importantly, the collaboration is highly capital-efficient for Medivir, as Vetbiolix or its future partner assumes all costs, including clinical development and commercialization, providing Medivir with pure profit upside and no financial downside.

Datum 2026-02-12, kl 08:30
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