- Another important milestone in the history of Bioceltix. The publicly traded veterinary company has submitted an application to the European Medicines Agency (EMA) for a positive recommendation for the stem cell-based drug BCX-EM for equine arthritis.
- The excellent results from the product’s clinical trial confirmed its efficacy and safety. The drug’s therapeutic effect persists even three months after a single dose.
- Bioceltix is pioneering biotechnology, developing innovative drugs for companion animals. The company is already on the EMA registration path for its marketing authorization application for BCX-CM-J for osteoarthritis in dogs. It has the potential to become the world’s first veterinary drug containing canine stem cells.
Arthritis occurs in almost all active horses, and most severely affects performance horses, particularly those exposed to the stresses of training. The disease manifests itself through pain, reduced locomotor performance, and lameness. Current treatment with traditional analgesics and anti-inflammatory drugs is associated with numerous side effects, and in the case of professionally engaged horses, it is virtually impossible, as many drugs have been added to the doping list. The Polish solution – the BCX-EM drug – heralds a breakthrough in global veterinary medicine and could reach veterinary shelves as early as 2026.
“This is a very important moment for us, as it culminates a long-standing team effort to develop a highly anticipated drug, this time for equine arthritis. The BCX-EM clinical trial was a great success and confirmed the efficacy and safety of our product, so we are optimistic about the entire registration process. We achieved all study objectives at both the primary and secondary endpoints. Furthermore, additional data analyses confirmed that the therapeutic effect of the product persists even three months after a single dose.” “The long-term effectiveness of BCX-EM and the fact that most of our patients returned to physical activity after three months in the study also means shorter rehabilitation, thus reducing the costs associated with long-term treatment,” says Dr. Paweł Wielgus, Eng., member of the Bioceltix management board. He emphasizes that currently, there is no widely available stem cell-based drug on the equine market, and competing products, due to the source of the cells and production technology, are therapies that are very difficult to access, and therefore have niche applications. Meanwhile, there are approximately 7 million horses in Europe who are potential patients of the Wrocław-based biotech company. Given the high prices of drugs for these animals – for example, competing products are offered at around €1,000 per dose – this creates a very attractive market.
A new drug that inhibits inflammatory processes at the molecular level and protects joint cartilage could revolutionize the treatment of arthritis in horses: such a product would not only reduce pain and improve the horses’ mobility but also extend their active lifespan.
Bioceltix cell therapies are coming to the public.
This is another Bioceltix product whose effectiveness has been confirmed by international clinical trials. The most advanced drug candidate in the company’s portfolio – BCX-CM-J for osteoarthritis in dogs – is already in the registration process with the European Medicines Agency. As part of the ongoing procedure, Bioceltix received a list of questions regarding the marketing authorization application submitted in May 2024. Importantly, the European Medicines Agency has raised no concerns regarding the product’s efficacy and safety.
“The ongoing dialogue with the EMA shows that the market regulator does not question either the safety or efficacy of our product for canine osteoarthritis. Therefore, we feel absolutely secure in key areas. We have also received a number of tasks and instructions regarding the BCX-CM-J production process. The registration process itself is experiencing a slight delay, although all the tasks we considered most time-consuming have already been completed. Unfortunately, this part of the project was overlapped by changes in the pharmaceutical quality system, specifically in the area of GMP, resulting from a regulation issued by the Minister of Health that came into force in December. These changes are not surprising to us, but we were unable to implement them in advance because it was not entirely clear how the European Commission guidelines would be implemented into Polish law. Most of the changes are more technical in nature, but they still require necessary work, documentation preparation, and integration with the current system. The entire process is under review; the documents will be submitted to the EMA in the second half of this year.” Importantly, when we receive questions from the EMA regarding an equine product—and in the case of innovative products, the regulator absolutely always asks questions—all changes resulting from the regulation will already be implemented. Therefore, this is in no way a factor limiting or delaying the registration of an equine product,” explains Dr. Paweł Wielgus.
The European Medicines Agency is the EU-level institution responsible for issuing recommendations for marketing authorization of veterinary medicinal products. The authorization itself is then based on a decision of the European Commission and is valid in all EU member states.
“This process is particularly important for innovative and biotechnological medicines, because central approval procedures ensure uniform standards of safety, efficacy, and quality of drugs available on the EU market,” reminds Paweł Wielgus.
Bioceltix is counting on the process of obtaining marketing authorization to proceed smoothly, both due to the excellent results of the clinical trial and the fact that the company consulted with the market regulator on its product development assumptions through the Scientific Advice body.
Strategic project positively assessed by PARP
Bioceltix is developing biologics that utilize the immunomodulatory properties of stem cells. These products, in addition to relieving pain, are designed to eliminate inflammation and provide a safer, more effective, and longer-lasting alternative to existing therapies. The company aims to combat the most common diseases in companion animals, focusing on inflammatory and autoimmune conditions. In both horses and dogs, Bioceltix targets diseases that mirror human lifestyle diseases. Currently, 15% of the canine population suffers from atopic dermatitis. Degenerative joint disease affects 20% of all dogs, although the percentage of patients is even higher among older dogs. In response to these challenges, the Wrocław-based company has developed BCX-CM-AD and BCX-CM-J, respectively. The large-scale stem cell plant under construction, which will ultimately produce Bioceltix drugs, is scheduled to launch in the second half of 2026. Last week, Bioceltix announced that the Polish Agency for Enterprise Development (PARP) had positively assessed the project for the new plant, submitted for funding in the “SMART Path” competition under the European Funds for a Modern Economy (FENG) program. After meeting the formal regulatory criteria, the company will be able to sign the agreement and receive funding.
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