The veterinary biotech company listed on the Warsaw Stock Exchange has published the full results of a clinical trial for an arthritis drug for horses. The results confirm the efficacy and safety of their revolutionary technology using mesenchymal stem cells.
The findings indicate that a single dose of BCX-EM achieved its therapeutic effect at all control points. Furthermore, surveys from pet owners indicate a significant extension of the product’s duration of action. This signals the markets’ potential for this Polish product, paving the way for the company to initiate the registration procedure for another pharmaceutical product at the European Medicines Agency (EMA).
Bioceltix is leading the field of biotechnology by developing innovative drugs for companion animals. The company is already on the EMA registration path for its most advanced product, BCX-CM-J, for canine osteoarthritis. It has the potential to become the world’s first veterinary drug containing canine stem cells.
The excellent clinical trial results for the BCX-EM product were not only confirmed in the primary endpoint areas, but also its efficacy and safety in secondary endpoint areas. This means that the Bioceltix arthritis treatment for horses works for at least 1.5 months after administration. Additional data from owner surveys reveal that the drug’s action may be significantly longer, at least three months. BCX-EM has the potential to revolutionize arthritis treatment for horses because of its causal mechanism of action, manufacturing technology, and scalability potential.
“We are extremely pleased with these results. We achieved all research goals at both the primary and secondary endpoints. The results confirm the statistically significant action of the drug and the sustaining of the therapeutic effect over a long period after administration. I wish to draw particular attention to the high-quality data showing that about 90% of our patients have returned to physical activity three months after. This signifies a shorter rehabilitation period, thus saving additional treatment costs. We have no doubt that the market is waiting for this product,” says Dr. Paweł Wielgus, a board member of Bioceltix.
In addition to Bioceltix’s second product validated by international clinical trials, the company’s most advanced drug candidate – BCX-CM-J for canine osteoarthritis – is awaiting positive market regulator recommendation. During the ongoing registration procedure, Bioceltix has already received a list of questions concerning the product portfolio submitted in May. Importantly, the European Medicines Agency has no objections to the efficacy or safety of the product.
Bioceltix is developing biological medicines using the immunomodulatory properties of stem cells to combat the most common diseases in companion animals, focusing on inflammatory and autoimmune conditions.
Arthritis is common in nearly all physically active horses, and most significantly affects sports horses faced with physical training stresses. The disease manifests as pain, reduced locomotion, and lameness. Previous treatments using traditional pain and anti-inflammatory medications are associated with many side effects and are often impossible in professional sports horses, as many substances are on the list of doping substances. BCX-EM looks set to bring a global breakthrough in veterinary medicine.
Currently, there is no widely available stem-cell-based drug on the equine market. Due to the cell sourcing and manufacturing technologies, competitive products are only available locally or not at all. The new drug which halts the inflammatory processes at the molecular level and protects the articular cartilage could revolutionize arthritis therapy in these animals. BCX-EM not only reduces pain and improves horse mobility but also has the potential to extend their active lives and reduce the costs associated with long-term treatment. In Europe alone we have around 7 million potential patients,” explains Paweł Wielgus.
Whether it be horses or dogs, Bioceltix aims for disease units corresponding to human civilization diseases. At present, as many as 15% of the dog population suffer from atopic dermatitis. A similar situation concerns degenerative joint changes, a disease affecting approximately 20% of all dogs, although the percentage of patients among older individuals is even higher. In response to these challenges, the Wroclaw-based company has developed BCX-CM-AD and BCX-CM-J. The latter product has the chance to become the first veterinary drug in the world containing dog stem cells. Its pilot sale should be possible by 2025, soon after the end of the registration process in EMA. The company’s large-scale stem cell manufacturing plant, which is intended to eventually produce Bioceltix drugs, is set to be launched in the second half of 2026. Until then, Bioceltix plans to produce pilot batches of the first product in the current plant.
Source: https://managerplus.pl/bioceltix-ma-pozytywne-wyniki-badania-klinicznego-produktu-dla-koni-polska-spolka-coraz-blizej-komercjalizacji-94617
