PeptidPro: Vesusten

2022: Entering the market and obtaining state registration

On June 27, 2022, PeptidPRO announced that it would enter the market and receive state registration for three injectable drugs: Vesusten, Fertiwell, Slavinorm.

According to the company, Vesusten is a prescription injection drug that has an organ-specific effect on bladder tissue for the pathogenetic course treatment of diseases accompanied by symptoms of HMP without significant side effects.

Vesusten is a prescription drug injection consisting of a complex of regulatory peptides with a molecular weight of no more than 10 kDA isolated from the bladder. Vesustene is a peptide regulator, has an organ-specific effect on the tissues of the bladder, realized through a cascade of peptide signals. According to clinical studies (CI Reports VST-10-2018 and VST-12-2019), the cascading mechanism of action of the drug increases the effect even after the completion of the treatment course in patients with overactive bladder (HMA) for at least three weeks. Clinical studies (VST-10-2018 and VST-12-2019) conducted according to GCP standards show that the drug, having a favorable safety and tolerability profile, improves the condition of patients with HMA: reduces the number of episodes of urinary incontinence, the frequency and severity of the urge to urinate. According to the results of a randomized, double-blind, placebo-controlled, prospective, multicenter clinical study of the efficacy and safety of phase III, a pronounced response to Vesusten therapy was observed in more than 60% of patients:

• 66.7% of patients had a reduction in symptoms on the Urinary Frequency and Urinary Urgancy Summary Scale (TUFS) by more than 20%, which exceeded the placebo group by 1.97 times;
• 65.3% of patients had a reduction in the daily number of incontinence episodes of 50% or more from baseline, the average decrease in the number of incontinence episodes exceeded the placebo group by 2.15 times;
• 89.3% of patients on Vesusten therapy had a decrease in the daily number of urinary incontinence episodes by 20% or more from baseline.

Another property of Vesusten is the effect of aftereffection, with a continued increase in efficacy within 3 weeks after the end of the course of therapy (the number of episodes of urinary incontinence decreases by 50% or more in 33.33% of patients immediately after the end of the course, reaching 65.3% after 3 weeks, there is a pronounced decrease in the symptoms of HMA according to the TUFS questionnaire from 54.05% to 66.7%).

The introduction of PeptidPRO drugs into wide clinical practice will begin in the fall of 2022.

For June 2022, we are at the beginning of the journey to unlock the extensive therapeutic potential of regulatory peptides. The drugs that PeptidPRO is developing are designed to combat socially significant diseases whose treatment is not optimal and does not provide a stable effect and/or an acceptable safety profile. We are pleased that we can offer the medical community other approaches to the therapy of socially significant diseases and expand the available therapeutic areas for the benefit of patients. Once again, I want to emphasize that an important feature of drugs based on regulatory peptides is their ability to exert a prolonged therapeutic effect even after discontinuation of therapy and a pathogenetic effect on the course of the disease, which fundamentally affects the prognosis of the course of the disease. In addition to the three drugs that have passed the registration, as of June 2022, there are more than 20 molecules in the PeptidPRO portfolio - candidates for the creation of drugs for which production technologies have been developed and introduced. pharmaceutical Preclinical safety and efficacy studies were completed for 10 active substances, and more than 10 drugs underwent proof-of-concept experiments. The company also plans to develop existing therapeutic directions through the withdrawal of drugs and indications (for example, treatment). erectile dysfunction The partner in the production of PeptidPRO drugs is the biopharmaceutical company SamsonMed. narrated by Natalia Bastrikova, Medical Director of PeptidPRO