Bioceltix has completed a pilot clinical trial of the product for atopic dermatitis in dogs, thanks to which it can start the actual clinical trial, which is the last stage before submitting an application for registration of the drug to the European Medicines Agency, the company announced.
“We are very pleased with the results of this pilot. They confirm unequivocally that the product works. I believe that we have quite a good chance of obtaining very good results in the future clinical trial, and consequently of registering the drug and successfully competing with the monoclonal antibody available on the market, which is so far the best drug for atopic dermatitis in dogs” – said a member of the board of Bioceltix Paweł Wielgus, quoted in the release.
The pilot study included 32 patients divided into 2 groups: 21 dogs treated with a single dose of Bioceltix and 11 dogs in a control group treated with three monthly doses of a reference monoclonal antibody for the treatment of symptoms of atopic dermatitis . The study was conducted in two research centers – at the University of Life Sciences in Wrocław and at the University of Life Sciences in Lublin. The observation time of a single patient was 12 weeks.
“Work on the clinical trial protocol is advanced, we can already implement the conclusions from the pilot. Funding for research is secured, we conducted the last issue of shares with great success, raising over PLN 20 million. We also delivered on our promise to apply for a grant to fund this research. We are in a very good position to continue talks with our potential strategic partners and we will see a lot of activity in this area in the coming weeks. Everything is in its place” – summed up Wielgus.
Bioceltix is a biotechnology company developing medicinal products for companion animals, with particular emphasis on dogs and horses. In November 2021, the company debuted on the NewConnect market.