The stock market-listed veterinary biotech company has announced preliminary positive results from the clinical trial of BCX-EM, a product designed to treat arthritis in horses. The results confirm the product’s effectiveness, measured 28 days after administration, in relation to the primary endpoint.
According to preliminary data, therapeutic effect was achieved in 64% of patients who received the Bioceltix product once, compared to 33% of patients in the placebo group. The obtained result is statistically significant. Its subsequent confirmation would mean successful completion of the clinical trial.
Thanks to its manufacturing technology and scalability, as well as the drug’s therapeutic mechanism, BCX-EM has the potential to revolutionize the treatment of horses suffering from joint diseases. Polish company’s projects, based on allogeneic animal stem cells, are among the most innovative of this type of therapy worldwide.
BCX-EM, designed to treat arthritis in horses, is one of the most advanced therapeutic projects in the biotech company’s portfolio, right after BCX-CM-J for osteoarthritis in dogs. It has just undergone a key verification, which preliminarily confirmed its effectiveness in respect to primary endpoints, i.e. 28 days after the product’s administration. The clinical trial, conducted in a model of a blinded, randomized trial, took place in several centers in Hungary, Ireland, Spain, and the Netherlands. The data on the results are preliminary and will be verified in the upcoming weeks, but the company’s representatives predict that the final conclusions from the study will remain unchanged.
A breakthrough alternative to current therapies
Bioceltix can potentially offer effective causal treatment due to the immunomodulatory properties of stem cells. The biological drugs developed by the Polish company not only alleviate pain but also eliminate inflammation. Therefore, they represent a safer, more effective, and longer-lasting alternative to therapies focused solely on symptom relief without halting the disease’s progression. Such a product could revolutionize arthritis therapy in these animals.
The company is currently awaiting the final validation of source data and confirmation of primary endpoints, which should occur within the next month. In the meantime, while awaiting additional information, such as secondary endpoints and detailed safety data, the group will begin work on the registration dossier. At the same time, it is conducting the necessary validation of production technology.
Bioceltix has in its portfolio one medicinal product for horses suffering from arthritis and two products for dogs – for atopic dermatitis (AD) and osteoarthritis. The pilot sale of BCX-CM-J should be possible shortly after the completion of the registration process in the EMA, planned for 2025.
The commercial launch of the first product from this biotech company is getting closer, hence Bioceltix has made a decision to speed up the construction of a new, large-scale production plant. The stem cell manufacturing plant, located in Wroclaw, is set to be launched in the second half of 2026.
Source: https://managerplus.pl/bioceltix-oglasza-pozytywne-wyniki-badan-klinicznych-leku-na-zapalenie-stawow-u-koni-99676
