- Bioceltix has announced that it has submitted responses to the European Medicines Agency (EMA) regarding questions related to the BCX‑CM‑J product. This is one of the key elements of the registration process preceding the marketing authorisation of the drug.
- BCX‑CM‑J, developed by the Wrocław‑based biotech company, has the potential to become the world’s first veterinary medicinal product containing canine stem cells. The very strong results of the clinical trial confirmed its long‑term efficacy and safety.
- Osteoarthritis statistically affects every fifth dog, with the percentage being even higher in older animals. Although the disease is the leading cause of chronic pain in dogs, it has so far been treated only symptomatically. The Polish solution aims to change that.
BCX‑CM‑J for osteoarthritis in dogs is the most advanced medicinal product in the Bioceltix portfolio. The listed company has just announced that it has submitted to the European Medicines Agency its responses to the questions raised by the regulator as part of the ongoing registration process. This is one of the key stages before the product can be placed on the market.
“We have addressed all areas discussed by EMA experts. By 15 July, we will receive follow‑up questions from the regulator, which we will also need to respond to. Once we review them, we will be able to determine with reasonable precision when the registration process should be completed. We expect that a positive recommendation for BCX‑CM‑J will be issued around the turn of the year. I would also like to remind you that EMA has no comments regarding the safety and efficacy of the product. Thanks to the advanced regulatory process and the very strong clinical trial results, we are close to introducing the world’s first veterinary medicinal product containing canine stem cells. I believe that both patients and the entire industry are waiting for this moment. The market need is enormous” – says Paweł Wielgus, Member of the Management Board of Bioceltix.
The medicinal product developed by the Polish company, based on canine stem cells, may be groundbreaking for the dog population. It is estimated that osteoarthritis affects statistically every fifth dog, but for animals over seven years of age, the rate rises to two‑thirds. The primary symptom of osteoarthritis is chronic pain leading to lameness, unstable and stiff gait, and difficulty standing up. The disease progresses relentlessly, and at a certain point the suffering makes normal functioning nearly impossible. Existing osteoarthritis treatments mainly non‑steroidal and steroidal anti‑inflammatory drugs and analgesics provide only short‑term, symptomatic relief. The same applies to the most modern therapy currently available, based on a monoclonal antibody, which acts solely as a pain reliever. The Bioceltix product works in a completely different way.
“BCX‑CM‑J provides long‑term, low‑level modulation of the inflammatory process occurring in the joint, which gives it a causal mechanism of action and, consequently, an analgesic effect. This means it may become an effective alternative to currently used therapies. From a business perspective, osteoarthritis in dogs is becoming an increasingly important market segment, which is reflected both in the sales performance of competing products and in the development strategies of the largest veterinary companies” – emphasises Paweł Wielgus.
The Management Board member adds that progressing to the next stage of the BCX‑CM‑J registration procedure allows the company to free up part of its resources and focus on the second project in its pipeline: a product for the treatment of joint inflammation in horses, which is also already on the EMA registration pathway.
“The detailed work schedule for BCX‑EM will largely depend on the July correspondence with EMA regarding the product intended for the treatment of osteoarthritis in dogs. At the same time, it is worth noting that the regulator’s questions concerning the equine product are in many areas analogous to those we received in the BCX‑CM‑J registration process. The experience gained during the development of our first product should translate into a more efficient and faster registration process for BCX‑EM” – says Paweł Wielgus.
New manufacturing facility to enable large‑scale production of future drugs
The time remaining until the commercialisation of the company’s first drug is being used, among other things, to expand manufacturing capacity to ultimately meet the demand for future medicines in international markets. A large‑scale stem cell manufacturing facility is being built in Wrocław. The clean rooms are expected to be commissioned in the second quarter of 2027. It is set to become the largest facility of its kind in the world.
“Between May and June, we expect the administrative decision regarding the building permit. In parallel, we are preparing a tender for the construction of the steel structure, and once it is awarded, we will be able to move on to the next stage of the investment. We assume that obtaining the building permit should proceed without major obstacles” – emphasises the Management Board member, adding that until the increased production capacity is achieved, the company plans to manufacture pilot batches of the first product at its current facility.