Russian medicine for hepatitis B included in the European PRIME program

| By | Clinical Trials, Drug Development, EMA
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Hepatera, a resident of Skolkovo Foundation’s biomed cluster, announced that MYRCLUDEX B, a medicine for hepatitis B that is being developed by the company, is included in the PRIME (PRIority MEdicines) program implemented by the European Medicines Agency (EMA). This is the first time that a product developed in Russia is included in the program; and it is also the first anti-infective medicine included in PRIME.

“MYRCLUDEX B is the first-in-class medicine for chronic viral hepatitis B (HBV) and co-infection with hepatitis D (HDV). The medicine blocks a cell entry receptor, that is common for HBV and HDV, and interrupts the life cycle of both viruses. The prolonged therapy reduces the number of infected cells, which may lead to complete cure of hepatitis or, at least, allow to control the inflammation caused by infection in the liver,” said Alexander Alexandrov, the Development Director at Hepatera.

By now, the clinical trials have been completed for Phase I and Phase IIa, in which 51 patients in Germany and 72 patients in Russia were successfully treated with MYRCLUDEX B. The trials demonstrated good tolerability and high antiviral activity of MYRCLUDEX B.

If the current trials show positive results, Hepatera plans to initiate the registration of medicine in the Russian Federation.

SOURCE: gmpnews.ru
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