Vesustim: the first clinical application results in the clinical trial in patients with an overactive bladder

The complexity and ambiguity of the treatment of overactive bladder syndrome (OAB), associated, first of all, with the lack of treatment options with high efficiency and good patient tolerance have been confirmed by the experts. The key problems are a low compliance of the available therapy approaches and the relatively high percentage of patients with various adverse events. The experts drew attention to the fact that in a number of experimental studies, the key mechanism of short-chain peptide bioregulators action has been established. This mechanism is presented by gene expression modulating and is realized through a cascade of peptide signals. An example of a drug that implements an effect on this pathogenetic pathway is the Vesustim. The experts agreed that Vesustim's mechanisms of action at the molecular level require further studies. At the same time, fundamental differences in the peptide regulators effect on cell and organ functions predetermine potentially high synergistic activity when combined with traditional treatment methods for patients with OAB. The results of preclinical Vesustim studies (5 mg - complex of polypeptides extracted from the bladder wall of cattle not older than 12 months of age) were evaluated. Experiments have shown that the drug has a regulatory effect on the wall muscle (detrusor) and urinary bladder sphincter contractile activity, and can be recommended for clinical trials in order to prevent and correct urinary disorders of various origins. The Vesustim clinical trials program in a dosage form of a lyophilisate for an injection solution (5 mg) preparation, to date, includes phases I and II. The Phase III trial has begun and will be completed 2020 year. The experts noted the need to continue the clinical trials program, including research of managing various variants of OAB, combined pathology and treatment in the combined therapy with other drugs. Also, there is a need for clinical trials of the postoperative management of patients after procedures on the urogenital system organs. □