- The stock market biotechnology company with a veterinary profile has launched an international clinical trial of a product for Atopic Dermatitis (AD) in dogs, entering the final stage prior to submitting an application for drug registration at the European Medicines Agency.
- The project related to atopic skin inflammation in quadrupeds also received a grant of almost 11 million PLN from the European Funds for a Modern Economy (FENG) program.
- The candidate for a drug against dog AD is a unique solution. Very good results from the pilot clinical trial unequivocally confirmed that Bioceltix therapy works after a single administration, heralding a breakthrough in the treatment of a disease affecting up to 15% of the canine population.
Wrocław, January 9, 2024 – After the success of the pilot trial, Bioceltix moves to the next stage of advanced work on the candidate for a drug for dog AD. The company announced that the product set to revolutionize atopic therapy was administered to the first patients as part of a multicenter clinical trial. Additionally, the project’s development will be supported by a grant of almost 11 million PLN within the European Funds for a Modern Economy (FENG) program. The company signed a co-funding agreement with the Polish Agency for Enterprise Development. The project submitted by Bioceltix covers the complete development pathway for the atopic product, including the costs associated with carrying out the clinical trial. The total value of eligible expenses in the project is approximately 17.5 million PLN.
– The funding obtained is of great importance for the development of this product. The market recognizes the potential in Bioceltix and our consistent work towards a breakthrough in the treatment of the most common inflammatory diseases in animals. We have high expectations for the clinical trial, good results will allow us to compete with the monoclonal antibody available on the market in the future. After the pilot clinical trial, we know that our product has a very favorable, long-term action profile. These are probably the first professionally obtained and prepared results in the world, showing that there is a possibility of effectively treating AD in dogs with intravenous stem cell administration – emphasizes Dr. Paweł Wielgus, a member of the Board of Bioceltix SA.
Currently, Bioceltix is beginning a proper, independent, multicenter, and double-blind clinical trial, the aim of which is to confirm the effectiveness and safety of using the developed product in dogs struggling with itching, erythema, or lichen. The study will be conducted at 20 clinics in Hungary, Portugal, Ireland, and Poland. A total of approximately 120 patients are expected to be recruited, divided into two groups: the test group, which will receive the BCX-CM-AD product, and the control group, which will receive a placebo.
– During the pilot trial, which confirmed the high efficacy and safety profile of our product, we observed that the lowest symptom readings occur at the end of the third month after administration, so there are grounds to assume that the product will work even longer – adds Paweł Wielgus, explaining that the previous pilot trial covered 32 patients divided into two groups: 21 dogs were given the Bioceltix product once, and 11 dogs in the control group were given the market-approved reference monoclonal antibody used in the treatment of AD, administered three times at monthly intervals.
Pioneering Technology for Animals Closer to Commercialization
Bioceltix emphasizes that the observed growing market demand for an effective drug against AD results from the increasing number of dogs suffering from this disease – it is estimated that nearly one in five is struggling with this condition, and currently available therapies don’t solve the problem because they only alleviate symptoms. Veterinary biotechnology offers a chance for a breakthrough, and the Wroclaw-based biotech plans to take advantage of this trend. The biological drugs that Bioceltix is working on are based on stem cells, which also act causally, i.e. by removing inflammation.
The company also commercializes two other pioneering biologic products – one for degenerative joint changes in dogs and one for horses suffering from arthritis. In the case of the first one, Bioceltix announced last month the success of complete results from a clinical trial, confirming the efficacy and safety of the developed therapy in both primary and secondary endpoints. The company highlighted the preservation of the therapeutic effect on the 45th and 90th day after administration of BCX-CM-J. Bioceltix representatives underline that this is a milestone on the way to registration and commercialization of the product, meaning the company could soon be the world’s first company to have marketing authorization for a therapeutic product containing dog stem cells.
The product for joint inflammation in horses is currently undergoing a clinical trial conducted in nearly twenty European clinics, including the largest and most renowned facilities dealing with horse health – the final stage of patient recruitment is underway. Concurrently with the three flagship projects, the company has begun work on a new product for treating dog AD. This will be a cell-free product using proteins and other substances produced and secreted outside by stem cells, found in the culture medium, as an active pharmaceutical ingredient. Interestingly, the so-called secretome is waste in the current technological process, but the creators of biotech see great therapeutic and commercial potential in it. Scientists announce that this solution is supposed to be complementary to the basic, cellular product for dog AD, while increasing the profitability of the main technological pathway.
– The use of such innovative technological achievements in veterinary medicine contributes to creating new treatment standards for our four-legged friends. At Bioceltix, we develop favorable alternatives to symptom-only acting and having many side effects chemical drugs. Let’s appreciate that we can effectively help sick animals. This approach is expected by their caregivers today, and hence the entire industry – says Paweł Wielgus.
There is a lot to fight for. The number of dogs in Europe at the end of 2022, for the first time in history, exceeded 100 million and everything indicates that the growth trend will continue. Among canines, an increase in the incidence of inflammatory and autoimmune diseases, such as osteoarthritis or atopic dermatitis, which are the equivalents of civilization diseases in the animal world, is forecasted.
The market for veterinary monoclonal antibodies, which are currently the best reference for future Bioceltix products, is expected to grow from the current 800 million USD annually to nearly 3.5 billion USD by the end of 2032.
