- A veterinary biotechnology company listed on the Warsaw Stock Exchange (GPW) has published the full results of a clinical trial of a product for equine arthritis. They confirm the efficacy and safety of the pioneering technology using mesenchymal stem cells.
- The results indicate that the therapeutic effect of a single dose of BCX-EM was achieved at all control points. Furthermore, caregiver surveys indicate a significantly extended duration of action of the product. This confirms the market potential of the Polish solution and paves the way for the company to begin the registration process for another medicinal product with the European Medicines Agency (EMA).
- Bioceltix is blazing a trail in biotechnology, developing innovative medicines for companion animals. The company is already on the EMA registration path for its most advanced product – BCX-CM-J – for osteoarthritis in dogs. It has the potential to become the world’s first veterinary medicine containing canine stem cells.
Wrocław, December 9, 2024 – The clinical trial results for BCX-EM have been confirmed not only for the primary endpoints, but also for its efficacy and safety with respect to secondary endpoints. This means that the Bioceltix medicinal product for equine arthritis is effective for at least 1.5 months after administration. At the same time, additional information obtained from owner surveys indicates that the drug’s effect may be significantly longer – at least 3 months. Thanks to its causal mechanism of action, as well as its manufacturing technology and scalability, BCX-EM has the potential to revolutionize the treatment of equine arthritis.
– We are extremely pleased with these results. We achieved all study objectives at the level of both the primary and secondary endpoints. The results confirm the drug’s statistically significant effect and the maintenance of the therapeutic effect long after administration. I particularly note the high-quality data showing that approximately 90% of our patients returned to physical activity after 3 months. This also means shorter rehabilitation, meaning additional savings in treatment. “We have no doubt that the market is waiting for this product,” says Dr. Paweł Wielgus, Eng., member of the Bioceltix management board, commenting on the results of an international clinical trial of the product for equine arthritis – a condition affecting almost all physically active individuals in this population.
Long-Term Effect Profile
The BCX-EM clinical trial involved 117 horses. The animals were divided into a treatment group receiving Bioceltix and a control group receiving a placebo. At the primary endpoint (28 days after product administration), 64% of patients met the defined success criteria, compared to 33% of patients in the placebo group. After 42 days after drug or placebo administration, these rates were 70% and 40%, respectively. Significant improvements were also observed in all other endpoints, including the flexion test, reduction in joint swelling, and pain analysis. In terms of safety, all parameters were also achieved as expected and assumed. The company emphasizes that the clinical trial statistically significantly confirmed the safety and effectiveness of the BCX-EM product, and that it has growing business hopes for the equine product.
“This year, we witnessed a very interesting acquisition in the veterinary industry. This acquisition involved a relatively small Australian company with a portfolio exclusively focused on equine products, and rather conventional ones at that. With revenues of PLN 60 million and EBITDA of PLN 29 million, the value of this transaction reached approximately PLN 320 million, almost the entire market capitalization of our company. And we’re talking exclusively about horses here. I think this quite accurately reflects the opportunities hidden in the equine market. And it further excites me when it comes to the potential of Bioceltix,” adds Wielgus.
This is the second 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 awaiting a positive recommendation from the market regulator. As part of the ongoing registration process, Bioceltix has already received a list of questions regarding the marketing authorization application submitted in May of this year. Importantly, the European Medicines Agency has not raised any concerns regarding the product’s efficacy and safety.
“The most important conclusion from the correspondence we received is that the EMA does not question the safety or efficacy of our product for canine osteoarthritis, which gives us great optimism for the remainder of the registration process. It is also worth emphasizing that BCX-CM-J for dogs and BCX-EM for horses address similar therapeutic areas. Both products, although manufactured from cells from different species, are based on the same production philosophy and technological platform. Based on the correspondence with the EMA, we can therefore conclude that the chances of successful registration of the product for horses are high. We are currently working very intensively to submit the registration documentation for BCX-EM in the first quarter of next year,” explains Dr. Paweł Wielgus.
Breakthrough Therapies for Animals Are Being Developed in Poland
Bioceltix is developing biologics that utilize the immunomodulatory properties of stem cells. It aims to combat the most common diseases in companion animals, focusing on inflammatory and autoimmune conditions.
In horses, arthritis occurs in almost all active individuals, and most severely affects sport horses, particularly those exposed to the stresses of training. The disease manifests itself through pain, reduced locomotor efficiency, and lameness. Current treatment with traditional analgesics and anti-inflammatory medications is associated with numerous side effects, and in professionally competing horses, it is often impossible, as many medications are listed as doping substances. BCX-EM heralds a breakthrough in global veterinary medicine.
“Currently, there is no widely available stem cell-based drug on the equine market. Competing products, due to the source of the cells and the production technology, are available only locally or not at all. These are premium therapies, with prices hovering around €1,000. A new drug that inhibits inflammatory processes at the molecular level and protects joint cartilage could revolutionize arthritis treatment in these animals.” BCX-EM not only reduces pain and improves mobility in horses, but also has the potential to extend their active lives and reduce the costs associated with long-term treatment. We see enormous market demand; we regularly receive inquiries about the availability of our product. Owners are seeking effective and more advanced therapies, and the veterinary industry is also turning to this direction. In Europe alone, we have approximately 7 million potential patients,” explains Paweł Wielgus.
The final report on the clinical trial of the equine product will be prepared in parallel with the registration dossier, similar to the product for canine osteoarthritis. The company then plans to initiate the drug registration process with the European Medicines Agency.
Biotechnology Helps Pets
For both horses and dogs, Bioceltix targets diseases that are analogous to human lifestyle diseases. Currently, as many as 15% of the canine population suffers from atopic dermatitis. A similar situation applies to degenerative joint disease – a disease affecting approximately 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 latter product has the potential to become the world’s first veterinary drug containing canine stem cells. Pilot sales are expected to be possible in 2025, shortly after the EMA registration process is completed. The large-scale stem cell facility currently under construction, which will ultimately produce Bioceltix’s medicines, is expected to be launched in the second half of 2026. Until increased production capacity is achieved, the company plans to produce pilot batches of the first product at its current facility.
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Bioceltix is a biotechnology company developing innovative medicinal products for companion animals, with a particular focus on dogs and horses. The company is developing a proprietary technology for the production of biological medicines based on mesenchymal stem cells. The breakthrough approach of Bioceltix involves the use of a method enabling the administration of stem cells from a small number of healthy donors to a large number of patients—an allogeneic model. Medicinal products developed in this way will be readily available, on-site at the veterinary clinic, and ready for administration to the patient immediately after thawing. Biologics developed at Bioceltix have the potential—in addition to their symptomatic effects—to also exert causal effects by influencing the inflammatory environment and triggering natural mechanisms for the regeneration of diseased tissues.