The drug against hepatitis C has entered the second phase of CI
The company "MIP-11" has started phase II clinical trials of the first in its class
innovative drug ABP-560 for the treatment of hepatitis C
The drug under development is an inhibitor of a new class that is radically different from all known HCV drugs currently being developed and has significant export potential.
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), is included in the list of socially significant diseases and the list of diseases that pose a danger to others. Once in the body, a viral infection damages the main functional liver cells (hepatocytes) and in most cases leads to the development of a chronic form of the disease. According to WHO, about 150 million people are chronically infected with the hepatitis C virus, and annually more than 350,000 people die from hepatitis C-related liver diseases.
ABP-560 suppresses the spread of HCV infection in cell culture not only through secreted viral particles, but also the spread of infection carried out through close cellular contact. This property is a fundamentally important advantage, since the spread of viral infection through cellular contact plays an important role in maintaining infection in the liver in chronic hepatitis C.
ABP-560 drug developed by MIP-11 LLC
blocks the penetration of the virus into healthy liver cells and prevents their infection
In a Phase I clinical trial conducted in 2013 on healthy volunteers, the safety, tolerability and pharmacokinetics of a single dose of ABP-560 at doses of 50, 100 and 150 mg were evaluated. It has been demonstrated that the drug has good tolerability and a favorable safety profile. The data obtained made it possible to reasonably continue clinical studies.
Already in April 2014, the resident of the Skolkovo Biomedical Cluster, MIP-11 LLC, received permission and launched phase II clinical trials of the drug ABP-560 in order to study its antiviral activity, safety and pharmacokinetics in monotherapy of patients with chronic hepatitis C who had not previously received treatment. This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The drug will be taken for two weeks in doses of 100 and 150 mg. The research will take place on the basis of leading specialized institutions Moscow and St. Petersburg.
Merkin Nikolay Alexandrovich, CEO of MIP-11: "Based on the data of preclinical and clinical studies, we can make an unambiguous conclusion that we have received a promising original drug for the treatment of hepatitis C, which can improve the existing treatment standards in Russia and in the world. And, thanks to the support of the RVC Seed Investment Fund and the Ministry of Industry and Trade of Russia, an effective innovative treatment for hepatitis C of domestic production may soon appear in Russian patients."
The MIP-11 company carries out research and development in order to create an innovative drug for the treatment of hepatitis C with the support of RVC Seed Investment Fund LLC and the Ministry of Industry and Trade of the Russian Federation within the framework of the federal target program "Development of the pharmaceutical and medical industry of the Russian Federation for the period up to 2020 and beyond".
Portal "Eternal youth" http://vechnayamolodost.ru21.04.2014