We have completed another phase of preclinical trials on a drug candidate that was
developed by combining our carrier with a substance that fights diabetes. The first phase of clinical trials on humans are scheduled to begin in 2023.
– We have obtained positive results from research on rodents large and small, which has allowed us to proceed to the next phase of testing – involving larger animals. Studies on pigs are ongoing and we are in constant touch with the research facility, which has not voiced any concerns regarding our transdermal system to this point; final results are expected by the end of September. Last year, we completed R&D of dapagliflozin, and are currently preparing methodology and validation procedures for stability studies. The next step will involve submitting a full set of documentation to the Office for Registration of Medicinal Products which will make it possible for us to enter the first phase of clinical trials.
We are currently in the process of shifting our technology from the lab development to production. That’s why, by way of a public tender, we’ve selected a company that will produce GMP-quality patches for use in our clinical trials – says Hanna Dopierała-Bartczak, Head of the Biotts Lab.
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