Bioceltix SA publishes the full results of a clinical trial of the product for lesions of the osteoarthritis in dogs. Company getting closer to drug registration and commercialization
After confirming the full efficacy of the therapy for osteoarthrosis in dogs on the primary endpoint, Bioceltix is publishing results that also include secondary endpoints endpoints (so-called secondary endpoints), so, among other things, the therapeutic effect achieved over a longer period of time after the drug’s administration of the drug.
“We are very pleased with these results, especially as they confirm a statistically significant reduction in lameness and pain of the treated joint in dogs and the maintenance of the therapeutic effect also at 45 and 90 days after treatment. These are important findings that can help build a sustainable competitive advantage in the market. We are also very pleased that once again all elements related to the safety of the drug have been confirmed. Of course, we have done the necessary research in this regard up to now, but during the clinical trial we worked with real patients, for whom the individual variability is very high. The secondary endpoints are of great importance to us in the commercialization process, highlighting the market potential of our drug candidate.” – says Pawel Wielgus, MD, a member of the Bioceltix SA Board of Directors, commenting on the results of an independent international clinical trial of the BCX-CM-J product for arthritis in dogs – a disease that is the most common cause of chronic pain in these animals, until now treated only symptomatically.
Bioceltix’s solution is revolutionizing existing therapies because, based on stem cells, it works both symptomatically and causally. The results from the study bring the company significantly closer to receiving a positive recommendation from the European Medicines Agency and to commercializing the product. And this would mean that the Polish biotech would be the first company in the world to have marketing approval for a medicinal product containing dog stem cells.
Long-term effect of pioneering therapy
A total of 102 patients took part in the clinical trial, of which 67 patients were in the study group with the BCX-CM-J product and 35 patients in the control group (they received saline as placebo). The clinical trial – with regard to the primary endpoint – was successful in confirming the efficacy and quality of the technology used, the company reported back in September this year.
The efficacy of the product was verified on day 30 (with a maximum deviation of 3 days) counting from the date of administration of the product or placebo. The success criterion was then reached by 70% of the dogs in the study group. In the group that received placebo, the same success rate was achieved by 26% of patients. The full results show, among other things, the efficacy of the product verified on day 45 and day 90 (with a maximum deviation of 5 days), counting from the date of administration of the product or placebo. Based on the verified results, 74% of dogs in the treatment group reached the primary efficacy criterion on day 45. In the group that received the placebo the same success rate was achieved by about 42% of patients. On the other hand, on the 90th day of the study, the success criterion was achieved by 81% of the dogs in the study group against 39% of the dogs that received the placebo.
“Summarizing the results of our survey, I can say that we achieved nearly 100% of all expected indicators. This level of success is very satisfying for us, because it shows that the goals at the level of secondary points were set adequately, and the results are in line with our ideas and expectations.”– explains Pawel Wielgus.
Biological drugs to the rescue of suffering quadriplegics
Osteoarthritis, through chronic inflammation, leads to gradual degeneration of joint cartilage. It is assumed that as many as 2/3 of dogs over the age of 7 suffer from it. The primary symptoms of osteoarthrosis development are the animal’s discomfort due to chronic pain manifested by lameness, a wobbly and stiff gait, problems standing up or a general reluctance to engage in physical activity. In veterinary medicine, the most common treatment is still traditional chemical drugs, fraught with the risk of side effects. The stem cell-based biologic drugs being developed by Bioceltix show a causal effect in addition to reducing pain, making them a safe and effective alternative to existing therapies.
“The very good results from the clinical trial are also important to us because the business potential for treating osteoarthrosis in dogs is huge. This is shown by the sales results of the current monoclonal antibody on the market for the treatment of pain in this disease entity. We have favorable business conditions, a rapidly growing market, a clear need on the patient side and sensational results, so everything is in place. And on top of that, we are proud to be able to effectively help sick dogs, changing the standards of therapy in veterinary medicine and making milestones in the entire biotechnology sector.” – comments Pawel Wielgus.