ChemRar Group announced successful completion of clinical trials to assess safety and tolerability of AV5080, a fundamentally new oral drug candidate formulation with a broad spectrum of anti-flu activity, including one for the treatment of flu strains of type A and B resistant to any existing first and second generation drugs.
The pharmacokinetics and safety of AV5080 have been evaluated in healthy volunteers who took the drug at doses of 30 mg, 80 mg, and 160 mg per day. The average daily concentrations during the five-day course were close to or substantially higher than EC50 of neuraminidase inhibition obtained for 10 flu virus strains even at a dose of 30 mg. The results of trials demonstrated the safety and good tolerability of the drug, as no adverse events were observed.
In 2017, ChemRar Group will continue its program of clinical trials to study the efficacy of AV5080. The trials will be conducted on flu-infected patients. In case of successful completion of clinical trials, AV5080 can become the first innovative oral medicine in Russia intended for treatment of infections caused by the flu strains of type A and B resistant to any existing first and second generation drugs.