Wrocław-based company develops groundbreaking drug to help sick animals
The excellent results of the clinical study of its product BCX-EM for equine arthritis have now been confirmed. This preparation remains effective for at least 1.5 months after administration, and evidence suggests that its effects could last much longer—at least 3 months. Thanks to its causal mechanism of action, scalable production technology, and potential for widespread application, this drug has the power to revolutionize veterinary treatments.
“We are extremely pleased with these results. They confirm the statistically significant effects of the drug and its long-lasting therapeutic benefits.”
— Dr. Eng. Paweł Wielgus, Member of the Board, Bioceltix
The market is ready for this product
Dr. Eng. Paweł Wielgus also highlighted the high-quality data showing that around 90% of the treated horses returned to full mobility after three months, leading to shorter rehabilitation times and reduced treatment costs.
“We have no doubt that the market is eagerly awaiting this product. Arthritis affects nearly all physically active horses.”
— Dr. Eng. Paweł Wielgus
The clinical trials have also confirmed the product’s safety and efficacy, strengthening the company’s confidence in its commercial potential.
Highchances for drug approval
This is the second Bioceltix product whose effectiveness has been validated by international clinical trials. The company’s most advanced product, a treatment for osteoarthritis in dogs, is currently awaiting a positive recommendation from regulatory authorities. According to Dr. Eng. Paweł Wielgus, the most crucial aspect is that the European Medicines Agency (EMA) has raised no concerns about the drug’s effectiveness or safety.
“This gives us great optimism. There is a strong chance of a successful registration for this product.”
— Dr. Eng. Paweł Wielgus
Currently, Bioceltix’s scientists are working intensively to submit the registration documentation for BCX-EM in the first quarter of next year.
7 million horses affected by this problem
Bioceltix is developing biological drugs that utilize the immunomodulatory properties of stem cells. The company aims to tackle common diseases in companion animals, particularly those with inflammatory and autoimmune origins. In horses, arthritis primarily affects sporting horses, which are highly exposed to training-related strain. The disease causes pain, reduced mobility, and lameness. Traditional treatments, such as painkillers and anti-inflammatory drugs, come with numerous side effects. Moreover, for professional sport horses, these treatments are often prohibited due to anti-doping regulations. In Europe alone, there are approximately 7 million potential patients.
A global breakthrough in veterinary medicine?
According to Paweł Wielgus, no widely available stem cell-based drug currently exists on the equine market.
“Competing products, due to the source of their cells and the production technology, are either only available locally or not at all. These are premium therapies, with prices around €1,000.”
— Dr. Eng. Paweł Wielgus
The new drug, which reduces inflammation at the molecular level and protects joint cartilage, could revolutionize the treatment of arthritis in horses. Not only does it alleviate pain and improve mobility, but it also has the potential to extend active lifespan and reduce the long-term costs of treatment. The final clinical trial report for the equine product is being prepared alongside the registration dossier, following the same process as Bioceltix’s osteoarthritis drug for dogs. The company then plans to begin the registration procedure with the European Medicines Agency.
Biotechnology for the benefit of animals
For both horses and dogs, Bioceltix is targeting diseases that mirror human civilization-related illnesses. Currently, 15% of the canine population suffers from atopic dermatitis, and degenerative joint diseases affect about 20% of all dogs—with even higher prevalence among senior dogs. To address these challenges, the Wrocław-based company has developed two key products: BCX-CM-AD (for atopic dermatitis) and BCX-CM-J (for joint diseases).
