The Russian drug for the first time entered the program of accelerated registration in Europe

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For the first time in the PRIME program of the European Agency for Medicines (EMA), intended for the accelerated registration of innovative drugs, a Russian development was developed - a tool for the treatment of Hepatitis B Myrcludex B from the company "Hepater", reported site of Skolkovo.
According to Alexander Alexandrov, Director of Development of Hepatery, Myrcludex B is the first-in-class drug for the treatment of chronic hepatitis B (HBV) and co-infection with hepatitis D (HDV).The drug blocks the common for HBV and HDV receptors of entering the cell and interrupts the life cycle of both viruses. Studies have shown that with prolonged therapy, the number of infected cells decreases, which can lead to complete cure of hepatitis, or at least control of infectious inflammation in the liver.
PRIME Program It was launched in 2016 and became the European analogue of the American program Breakthrough Therapy Designation. Its main goal is the organization of operative communication of the regulator with the developers of breakthrough medications in those areas of medicine where there is currently a significant unmet medical need for innovative therapies. Participation in this program allows you to get a comprehensive expert evaluation, to compile on its basis an optimal plan that allows you to bring the drug to the market in a short time.
"Participation in the PRIME program is very important for us: First, we have already received a positive evaluation of the EMA, having passed the selection procedure, according to EMA data, at the end of May, 108 applications from drug developers were submitted to the program (see reference), 9 of them development of anti-infective drugs.Approved only 25 applications, including Myrcludex B, the first and to date the only approved anti-infectious drug, "- said Alexandrov.
Clinical studies of 1 and 2a phases have now been completed, within the framework of which 51 patients in Germany and 72 patients in Russia successfully underwent therapy with Myrcludex B. Studies have shown good tolerability and high antiviral activity Myrcludex B. Now the company "Hepatera" is implementing a program of clinical trials of the drug for the treatment of co-infection of chronic viral hepatitis B and Delta.
In parallel, 2 clinical trials of phase 2c are under way, in which safety and antiviral activity in the dose range is studied against tenofovir, and the effect of Myrcludex B therapy in combination with pegylated interferon is evaluated. Studies are taking place in the clinical centers of Russia and Germany, their completion is planned in 2018. When receiving positive results of current research, "Hepatera" plans to initiate a registration process on the territory of the Russian Federation.

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