NanoViricides has submitted a pre- Investigational New Drug (IND) briefing document of its anti-influenza drug candidate, FluCide to the US Food and Drug Administration (FDA).
In a lethal influenza infection mouse model, FluCide has shown to be highly effective in controlling viral influenza compared with TamiFlu, the current treatment standard. The company intends to use the pre-IND application to obtain concurrence from the FDA on its planned toxicological studies, as well as the general plan for the early human clinical trials.
The pre-IND Meeting is expected to take place in March-April 2012. Additionally, the company plans to discuss its Chemical Manufacturing and Controls (CMC) program for the cGMP manufacture of FluCide in the meeting. NV-INF-1, the selected candidate drug substance of the FluCide program, has shown viral load reduction of 1.3 logs to 3 logs in various studies.