The world of veterinary medicine sounds the alarm: chronic use of anti-inflammatory drugs in companion animals causes a long list of side effects. At the same time, the number of patients suffering from inflammatory and autoimmune diseases continues to rise and there is a burning need for new-generation therapies improving the quality and comfort of pets’ lives. We at Bioceltix took the challenge to address the most significant therapeutic areas – with much expected, highly advanced medicines.
The statistics are inexorable
More than 20% of dogs suffer from osteoarthrosis (with a much higher percentage in older ones or particular breeds representatives), which is the main cause of chronic pain in this species; 15% of the canine population is affected with atopic dermatitis. 30% of the horse population suffers or will suffer from – again – osteoarthrosis which is manifested as decreased locomotor performance and lameness. In most cases, this is accompanied by degenerative lesions of the joints, where mechanical damage to the cartilage tissue causes an immune response manifested as pain. This is observed particularly in sport horses, which have the highest prevalence of arthritis among all utility horses. The abovementioned afflictions are already the animal equivalents of human civilization diseases.
Meanwhile, numerous studies indicate that “biological” means an effective and safe alternative to symptomatic pharmacotherapy focused mainly on alleviating pain and inflammation. Emerging veterinary biotechnology has the potential to provide new, tech-driven therapeutic products, increasing the effectiveness of treatment while reducing the incidence of side effects or as in the case of stem cells, providing a chance for causative – not only symptomatic – treatment.
Spotlight on the stem cell drugs
When developing biological medicines, we rely on factors secreted by mesenchymal stem (stromal) cells (MSC), which constitute a natural mixture of substances showing strong immunomodulatory properties. The active
substance of the therapies contains a suspension of live MSCs derived from adipose tissue. Due to the natural character of these substances and their prevalence in the body, their safety and efficacy are considerably higher compared to conventional treatment. We develop allogeneic donor-based cell therapy which delivers potentially widely available off-the-shelf products. Owning GMP production facility, we provide single technology for several species, diseases, and routes of administration.
Let’s dive deeper into new possibilities – stem-cell based medicines to treat inflammatory and autoimmune diseases in companion animals:
- BCX-CM-J represents a somatic cell therapy product in the form of a suspension of live allogeneic mesenchymal stem cells intended for intra-articular injections to treat osteoarthritis in dogs, manifested by pain and lameness of the animal. Our pivotal study confirmed the high efficacy of BCX-CM-J – therapeutic effect demonstrated both in short (30 days) and long (90 days) terms after a single administration. The product is successfully advancing its Marketing Authorization application with the European Medicines Agency (EMA).
- BCX-EM is a second veterinary biological drug based on stem cells, intended to treat canine atopic dermatitis. It contains mesenchymal stem cells used in intra-articular injections to treat equine osteoarthritis therapy, caused by inflammation of the joints, resulting from excessive strain on the locomotor system. The final results of our pivotal study confirmed the product’s high efficacy and safety both in the short and long term. Currently we are approaching the EMA application.
- BCX-CM-AD utilizes allogeneic MSCs with intravenous administration to treat canine atopic dermatitis. Historically our pilot study performed on a group of 30 animals showed high efficacy and therapeutic potential of the product, demonstrating strong anti-inflammatory effects. Currently we approach the end of observation phase in a pivotal study. Meanwhile, however, an interim analysis enabled a reduction in the initial number of patients recruited for the clinical trial by approx. 30%.
Key commercialization steps may occur as the EMA registration process moves on. With the BCX-CM-J, Bioceltix has a chance to be the first company worldwide to have Marketing Authorization for canine stem cell-based biopharmaceuticals for veterinary use.
Furthermore, we see great therapeutic potential in another ongoing project for the treatment of atopic dermatitis in dogs. We work on the BCX-CM-Sec that is going to be a cell-free product using proteins and other substances produced and secreted externally by stem cells as the active pharmaceutical ingredient.
Social trends challenge the industry and trigger the animal health market
When we talk about biotechnology, we often think of groundbreaking solutions for humans. Veterinary biotechnology is, however, a noteworthy niche, especially in the companion animals market. The potential of the industry in the context of current social trends is enormous. People treat animals as full-fledged family members, which translates into more and more pets having regular and advanced veterinary care. Caretakers are eager to spend more money on treatments while expecting it safer and quickly implemented. Worldwide, we are facing unprecedented pressure on the market as people want better food, newer technologies, and highly effective therapies for their pets.
It is worth mentioning that the market for veterinary monoclonal antibodies, which are currently the best reference for Bioceltix products, is expected to grow from the current $800 million a year to nearly $3.5 billion by the end of 2032. Also, for the first time, the number of dogs in Europe exceeded 100 million at the end of 2022, and all indicate that the upward trend will continue, according to Statista. In consequence, the age-related disease incidence rate will also continue to rise. I strongly believe the development of innovative technological advances in veterinary contributes to creating new and much more effective standards of treatments that shape the future of pet medicine. We are happy to help companion animals effectively and modernly. This is what their caretakers wish, and therefore, the entire industry expects.