Bioceltix on final straight to complete first clinical trial

04.11.2022

In September this year, Bioceltix, a Wroclaw-based biotechnology company with a veterinary profile, went public on the WSE's main market. This is part of a consistently implemented strategy aimed at developing medicinal products for companion animals with a particular focus on dogs and horses, based on proprietary technology using mesenchymal stem cells. Now Bioceltix is on the final straight to complete a clinical trial for one of the products under development.

Bioceltix is working in parallel on three therapeutic products – two drug candidates for dogs, addressing osteoarthritis and atopic dermatitis, and one drug candidate for horses suffering from arthritis. The project on osteoarthritis lesions in dogs is the most advanced, as it is in the clinical trial stage. The company has just reached the halfway point at the recruitment level, reporting that 63 of the targeted 135 canine patients are currently in the clinical trial, with another 11 qualified for the study.

“We have received information from our contractor on the current status of the clinical trial implementation. At this stage, there are two main conclusions from the study. First and foremost, the partial results are in line with our assumptions and expectations. We see a clear, favorable difference between the patients who received our product and the placebo group. Second, the pace of recruitment, and thus the implementation of the study, is in line with the approved schedule.”
– says Pawel Wielgus, MD, a member of Bioceltix’s board of directors.

Does this mean that the clinical trial will be successful?

According to the study’s protocol, Bioceltix will only present final efficacy results after the clinical trial is completed. The company’s management comments on the matter rather cautiously.

“These are partial results for now, which cannot prejudge the outcome of the entire clinical trial. We still have too small a sample to do a statistically correct analysis. A hint may be that the results so far look promising compared to the parameters obtained in clinical trials for other biologic drugs that have subsequently received marketing approval. Hopefully, this trend will continue for a larger statistical group.” – adds Wielgus.

Some restraint and lack of over-optimism may also result from the fact that, as Wielgus points out, the analysis of clinical trial results is quite complex and is not based on the evaluation of a single percentage denoting a drug’s efficacy, but on a statistical analysis that takes into account the interrelationship between the test product group and the placebo group, as well as the size of the overall sample, which in turn derives from the assumptions of the epidemiological assumptions for a given disease entity.

“That’s why we don’t give specific numerical values at this stage, so that incorrect interpretations don’t occur. We can only share a reflection that we are optimistic about the near future.” – Wielgus concludes.