Ural Federal University: University and Pharmaceutical Company Create Drug to Treat Complications of Diabetes Mellitus
Scientists of the Ural Federal University and their colleagues from the Volgograd State Medical University have created a drug with the conventional name AB-19 for the prevention and treatment of complications of diabetes. They already have three patents of the Russian Federation: for the method of obtaining a substance with antiglycemic activity, for the method of obtaining a pharmaceutical composition based on it and for its use as a means of treatment and prevention of late complications of diabetes. The scientists also concluded an agreement with a Russian pharmaceutical company to attract investment and the subsequent launch of the drug on the market.
“At the moment, the pharmaceutical company, with our direct scientific and technological support, is organizing the production of a pilot batch of the finished dosage form in capsules in the required doses and in the required quantities. We are also preparing a registration dossier for certification of the drug and obtaining permission from the Ministry of Health of the Russian Federation to conduct clinical trials,” explains Svetlana Kotovskaya, senior researcher of the Fundamental Research Laboratory of Physiologically Active Substance at UrFU.
In the case of successful clinical trials, Russia will have an innovative drug for the prevention and treatment of diabetes complications. This is extremely important because there are currently no drugs with a similar mechanism of action – blocking the main pathways for the development and progression of late complications of diabetes mellitus.
One of the main causes of disability in patients with diabetes is the effect of hyperglycemia and the reaction of protein glycation on human organs and tissues. This leads to the development of various complications: kidney failure (diabetic nephropathy), pigmented lesions of the nervous system (neuropathy), heart failure (cardiomyopathy) and others.
“One of the compounds, with the conventional name AB-19, demonstrated efficacy as a drug for the prevention and treatment of complications of diabetes and was recommended for preclinical studies. In accordance with the requirements of the Ministry of Health of the Russian Federation, we conducted a full range of preclinical studies: specific pharmacological activity and safety of the medicinal product, developed the production technology, quality indicators and quality control methods for the pharmaceutical substance and finished dosage form on its basis, and also conducted studies to establish the mechanism of action, prepared the regulatory and technical documents necessary to obtain approval for the first phase of clinical trials,” explains the author of the study.
In 2017, scientists of the Ural Federal University together with the Volgograd State Medical University won the competition of the Ministry of Higher Education and Science of the Russian Federation within the program “Pharma-2020”. Scientific work was carried out under the state contract “Preclinical studies of a drug acting on advanced glycation end-products (AGE) and their receptors (RAGE) for the prevention and treatment of complications of diabetes mellitus”. The creation of the drug AB-19 is the result of work on this project.