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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.

For additional information, please contact;
Magnus Christensen
Chief Financial Officer
Medivir AB
Phone: +46 8 5468 3100
Email: Magnus.Christensen@medivir.com

About Medivir
Medivir develops innovative therapies targeting areas of high unmet medical need. Its drug candidates focus on indications where current treatment options are limited or non-existent, offering the potential to deliver meaningful improvements for patients. Medivir’s two lead programs are fostrox, a precision chemotherapy designed to selectively target liver cancer cells while minimizing side effects, and MIV-711, aimed at treating Osteogenesis Imperfecta (brittle bone disease). Both candidates have blockbuster potential, representing significant value creation opportunities for Medivir’s shareholders and affected patients. Collaborations and partnerships play a key role in Medivir’s business model, with drug development conducted either in-house or in partnership. Medivir (Nasdaq Stockholm: MVIR) is listed on the Small Cap segment of Nasdaq Stockholm. More information is available at www.medivir.com

About Vetbiolix
Vetbiolix develops first-in-class clinical-stage drug candidates (oral small molecules) for the treatment of canine and feline periodontitis, osteoarthritis and intestinal motility disorders. Vetbiolix has built a unique pipeline of innovative drug candidates licensed (exclusive and worldwide license) from Human Health Biotech companies worldwide that will address unmet veterinary medical needs. Vetbiolix focuses exclusively on the clinical developments of its drug candidates and invests in (i) proof-of-concept clinical studies, (ii) CMC-Pharmaceutical developments, and (iii) regulatory clinical pilot and pivotal studies. The company's revenue generation will be based on sublicensing and/or co-development agreements with the veterinary pharmaceutical industry. www.vetbiolix.com

About VBX-1000 (MIV-701)
VBX-1000 (MIV-701) is a first-in-class cathepsin K inhibitor in development to stop bone resorption and contribute to bone generation in dogs and cats with periodontal disease. Cathepsin K is the principal protease involved in breaking down collagen in bone and cartilage. VBX-1000 (MIV-701) has been shown to have a positive impact on alveolar bone loss in dogs with periodontal disease. By inhibiting cathepsin K and increased/excessive activity of osteoclasts, VBX-1000 (MIV-711) has the potential to counteract excessive bone resorption, and it restores the balance between excessive bone resorption and bone formation.

About periodontal disease
Periodontal disease (PD) is one of the most common health conditions in dogs. Only the earliest stage of the disease is reversible; once bone loss occurs, it cannot be restored. Stopping bone loss as early as possible is therefore critical to preventing disease progression and permanent damage. PD affects approximately 80 % of dogs over three years of age, representing a substantial portion of the pet population. In the United States, with around 90 million pet dogs, an estimated 50 million may be affected by periodontal disease. In the EU‑27, where there are approximately 69 million dogs, roughly 40 million are likely affected. Combined, the U.S. and EU‑27 account for more than 90 million dogs with periodontal disease. Despite this enormous unmet need, there are currently no approved drugs that can stop or reduce alveolar bone resorption in pets, underscoring a significant commercial opportunity for a first‑in‑class disease‑modifying therapy that can prevent disease progression and reduce long-term complications.

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Datum 2026-02-12, kl 08:30
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