- A veterinary biotech company listed on the Warsaw Stock Exchange (GPW) has published the final results of a clinical trial of BCX-CM-AD for atopic dermatitis (AD) in dogs. These confirm the safety and effectiveness of Bioceltix’s cell therapy in the short, medium, and long term.
- A single administration of the drug significantly alleviated skin lesions in dogs after less than a month, and the therapeutic effect persisted for up to three months after administration. The Polish company is now preparing to submit its third drug for registration with the European Medicines Agency (EMA).
- The Wrocław-based biotech’s stem cell-based solution could become the gold standard for treating AD, a condition affecting as many as 15% of the canine population.
Wrocław, August 12, 2025 – Atopic dermatitis affects nearly one in seven dogs. It is a troublesome condition, as the dog’s skin becomes inflamed and very itchy. Lesions most often appear on the face, paws, and sides of the body. Although atopic dermatitis is a chronic condition, symptoms can worsen seasonally. The problem is that symptomatic treatment remains the standard in veterinary medicine. A Polish solution offers the potential for a global breakthrough. Bioceltix has just announced that its unique stem cell-based product, BCX-CM-AD, has passed a key verification – a clinical trial has confirmed the safety and effectiveness of BCX-CM-AD in the treatment of atopic dermatitis in dogs.
“We are extremely pleased with the results of this study. We are particularly pleased with the long-term results obtained after the product was administered. Let me remind you that we want to register this drug as an extension of our product’s use for osteoarthritis in dogs. Once we complete the registration of the intra-articular product, judging by the quality of the atopic results, we should have no problems with marketing authorization. Of course, we are pressed for time; patients are waiting,” says Dr. Paweł Wielgus, a member of the Bioceltix management board. “With BCX-CM-AD, we’re proving that it’s possible to effectively treat inflammatory and autoimmune diseases using intravenously administered stem cells. This also gives us the opportunity to develop the product in the future to treat other autoimmune diseases, such as inflammatory bowel disease or chronic kidney disease. The possibilities are truly exciting,” adds Paweł Wielgus, commenting on the results of a multicenter clinical trial that aimed to confirm the efficacy and safety of Bioceltix in dogs with pruritus, erythema, and ringworm. The trial was conducted in more than a dozen clinics in Portugal, Ireland, and Hungary. Clinical Trial Successfully Completed
A total of 95 patients participated in the clinical trial, divided into the study group (64 dogs receiving BCX-CM-AD) and the control group (31 dogs receiving placebo), of which the final number of patients meeting the clinical protocol requirements was 88. Statistical significance was achieved for the primary endpoint of skin lesion reduction, confirming the product’s efficacy on day 28 +/- 3 after drug administration. This marks the successful completion of the study. For both skin lesions and pruritus, the treatment’s effectiveness was also confirmed on the co-primary mid- and long-term endpoints: on day 56 +/- 3 and day 84 +/- 3.
– The results indicate a strong anti-inflammatory effect of our product, leading to faster improvement in skin lesions in dogs and, consequently, to a reduction in pruritus. We are somewhat disappointed by the lack of statistical significance in itch reduction in the short term, but this was an expected effect and consistent with the results we obtained in a pilot clinical trial last year. This is due to the mechanism of action of BCX-CM-AD, which primarily reduces inflammation, and therefore acts causally. As a result, itch reduction is delayed because it occurs as a result of inflammation reduction, not as a direct effect on the itch transmission pathway, which is a symptomatic effect. The lack of statistical significance in this single point will not affect the EMA’s decision; instead, we will discuss what therapeutic claims we can make. And in this context, the key is that the antipruritic effect in the medium and long term is undeniable. I am known for my reserve, but I can confidently say that these results are very good,” explains Paweł Wielgus.
Pet owners and global big pharma have increasingly high expectations for modern and increasingly effective treatments for atopic dermatitis. Market demand for an effective drug is growing, as the number of dogs suffering from this condition is rapidly increasing. The reason? A growing number of allergens are causing allergic reactions in animals – both in food and in the air. Currently available pharmacological therapies do not solve the problem, as they only eliminate symptoms. They can also cause excessive suppression of the immune system, which in turn often leads to secondary infections, such as fungal infections.
– A previous clinical pilot showed us that the therapeutic effect of our product on atopic dermatitis can last longer than three months. Therefore, to assess the long-term effectiveness and safety of this product, we included additional readings in the clinical trial at approximately 112, 140, and 168 days after administration of the test product or placebo. We are still awaiting these additional results. These are of a supportive nature, but if successful, they may be taken into consideration by the market regulator, says a company representative.
On the way to the European Medicines Agency
Bioceltix is currently addressing the most rapidly developing therapeutic areas in small animal veterinary medicine – in addition to atopic dermatitis in dogs, it also targets osteoarthritis, which affects an average of one in five dogs and as many as two-thirds of the dog population over 7 years of age. This disease may soon be effectively and sustainably combated, as Bioceltix’s drug BCX-CM-J, following excellent clinical trial results, is in the registration phase with the European Medicines Agency. The BCX-CM-AD product for atopic dermatitis is to be submitted for registration to the EMA as an extension of the BCX-CM-J product to include a new therapeutic indication. This will eliminate the need for re-validation of the product’s manufacturing process, and dialogue with the EMA should be limited to issues related to the mechanism of action and the product’s safety and efficacy.
Bioceltix is also in ongoing contact with the market regulator regarding BCX-EM for equine arthritis.
“We have just received a working list of questions from the EMA regarding the application for a positive recommendation for marketing authorization for the equine drug, and the final version should be received by September 11th. After a preliminary analysis of the questions, we see that the process is proceeding according to our assumptions and we have not identified any above-average risks that could negatively impact its progress. This stage is no stranger to us, thanks to our experience with the product for canine osteoarthritis already submitted to the EMA. However, BCX-EM concerns a different species, so we cannot make a simple translation from dog to horse. However, there are areas that these two products share, so it will certainly be a bit easier and faster,” says Paweł Wielgus.
There will be drugs, so there must be a large-scale production facility.
The company is using the time until drug registration to expand its manufacturing capacity, among other things. Bioceltix recently announced the acceptance of space for a new, large-scale production facility. The design for a building permit has already been completed, and the first detailed designs are being finalized. The company’s management also announces that the first tenders will be announced soon.
As a reminder, the company received a conditional grant of PLN 17.35 million from the Polish Agency for Enterprise Development (PARP) for the construction of the plant under the European Funds for Modern Economy (FENG) program. The large-scale plant will be built in Wrocław and will ultimately meet the global demand for Bioceltix medicines. The plant is expected to be operational by the end of 2026. It will likely be the largest plant of its kind in the world.
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