Russian medicine for TBE is preparing for Phase I clinical trials

| By | Clinical Trials, Development of Vaccines, Drug Development

Before the end of this year, the scientists of the Institute of Chemical Biology and Fundamental Medicine (ICBFM) of the Siberian Branch of the Russian Academy of Sciences in Novosibirsk plan to file application with the Ministry of Health of the Russian Federation for authorization to conduct Phase I human clinical trials for Encemab, a medicine for tick-borne encephalitis (TBE). The trials on mice revealed that the new drug was 500 times more potent than currently used immunoglobulin serum, said Nina Tikunova, head of the Molecular Microbiology Lab at ICBFM SB RAS.

According to Nina Tikunova, Phase I clinical trials will cost €170-200 thousand, and such trials usually take about 1-2 years.

She added that pre-clinical trials on mice conducted by Siberian scientists confirmed high efficacy of Encemab, which was hundreds times higher than that of serum immunoglobulin.

“However, we were very much surprised that it turned out to be absolutely non-toxic. We used 20-fold and 100-fold doses and found no toxic effects, while the serum medicine (immunoglobulin) showed them even at significantly lower doses,” said Ms. Tikunova.

She noted that Encemab demonstrated not only curative but also protective property and, in the future, it can be used for emergency vaccination or even prior to eventual contact with tick before going to the forest.