Bioceltix from Wrocław begins the registration procedure for an arthritis drug for horses

Arthritis occurs in nearly all physically active horses and most significantly affects sport horses that are particularly exposed to training-related strain. The disease manifests as pain, reduced locomotive performance, and lameness.

Traditional treatment with anti-inflammatory and analgesic drugs involves many side effects, and for professionally trained horses, it is virtually impossible, as many substances are on the list of doping agents. The Polish solution — the BCX-EM drug — promises a breakthrough on a global scale in veterinary medicine and may hit veterinary shelves as early as 2026.

“This is a very important moment for us, as it crowns the years-long effort of the entire team to develop a drug eagerly awaited by the market — this time for arthritis in horses. The BCX-EM clinical trial ended with great success and confirmed both the effectiveness and safety of our product, which gives us an optimistic outlook on the entire registration process. We achieved all trial objectives, both primary and secondary endpoints. Moreover, additional data analyses confirmed that the therapeutic effect of the product lasts even three months after a single dose administration. The long-term effectiveness of BCX-EM and the fact that most of our study patients returned to physical activity after three months also means shorter rehabilitation periods, and thus lower costs associated with prolonged treatment,” says Dr. Eng. Paweł Wielgus, Management Board Member at Bioceltix. He emphasizes that currently, there is no widely available stem cell-based drug on the equine market, and competitive products, due to the origin of the cells and production technology, are difficult to access and have niche applications. Meanwhile, in Europe, there are about 7 million horses that are potential patients for the Wrocław biotech company, which — considering the high price of equine drugs (e.g., competing products are offered at around one thousand euros per dose) — represents a very attractive market in terms of value.

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 mobility but also extend their active life.

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 canine osteoarthritis — is already undergoing the registration process at the European Medicines Agency. As part of the ongoing procedure, Bioceltix has received a list of questions related to the marketing authorization application submitted in May 2024. Importantly, the European Medicines Agency has not raised any concerns regarding the product’s efficacy or safety.

“The ongoing dialogue with EMA shows that the market regulator does not question either the safety or the effectiveness of our product for canine osteoarthritis. In these key areas, we feel absolutely secure. We have also received a number of tasks and guidelines regarding the BCX-CM-J production process. We are slightly delayed in the registration process, but all the tasks we considered most time-consuming have already been completed. Unfortunately, changes to the pharmaceutical quality system — specifically the GMP area — resulting from a regulation by the Minister of Health that came into effect in December, overlapped with this part of the project. These changes did not come as a surprise to us, but we could not implement them earlier because it was unclear how the European Commission’s guidelines would be transposed into Polish law. Most of the changes are of a technical nature but still require necessary work, documentation preparation, and integration with what we already have. The entire process is under control, and the documents will be submitted to EMA in the second half of this year. What’s important is that by the time we receive questions from EMA regarding the equine product — and for innovative products the regulator always asks questions — all changes required by the regulation will have already been implemented. Therefore, this is in no way a limiting or delaying factor for the equine product’s registration,” explains Dr. Eng. Paweł Wielgus.

The European Medicines Agency is the EU-level institution responsible for issuing recommendations for the marketing authorization of veterinary medicinal products. The authorization itself is then granted based on a decision by the European Commission and is valid in all EU member states.

“This process is particularly important for innovative and biotechnological drugs, as centralized approval procedures ensure consistent standards of safety, efficacy, and quality for medicines available on the EU market,” reminds Paweł Wielgus.

Bioceltix is counting on a smooth marketing authorization process for its drugs, due both to excellent clinical trial results and the fact that the company has consulted with the market regulator under the Scientific Advice program regarding its product development strategies.

Bioceltix is developing biological drugs that utilize the immunomodulatory properties of stem cells. In addition to alleviating pain, these products are designed to eliminate inflammation and serve as a safer, more effective, and longer-lasting alternative to current therapies. The company aims to combat the most common diseases in companion animals, focusing on inflammatory and autoimmune conditions. For both horses and dogs, Bioceltix targets diseases that are counterparts to human lifestyle diseases. Currently, 15% of the canine population suffers from atopic dermatitis. Degenerative joint diseases affect 20% of all dogs, with an even higher percentage among older individuals.

In response to these challenges, the Wrocław-based company has developed BCX-CM-AD and BCX-CM-J. The large-scale stem cell manufacturing facility, where Bioceltix’s drugs will eventually be produced, is scheduled to open in the second half of 2026. Last week, Bioceltix announced that the Polish Agency for Enterprise Development (PARP) had positively evaluated the company’s project for the new facility, submitted for funding under the “SMART Path” competition as part of the European Funds for a Modern Economy (FENG) program. After fulfilling formal eligibility criteria, the company will be able to sign a contract and receive the funding.