Thursday, November 21, 2013 by Proactive Investors
Biotron Limited will conduct a three month Phase 2 dosing study of its BIT225 drug candidate for the treatment of the Hepatitis C virus.
Biotron Limited (ASX: BIT) has received ethics approval to conduct a three month Phase 2 dosing study of its BIT225 drug candidate for the treatment of the Hepatitis C virus.
The study will be conducted on 60 patients at up to six trial sites in Thailand with the primary site - Bangkok’s Siriraj Hospital – granting the ethics approval.
Initial patients are expected to commence dosing by the end of this month and the trial is expected to be fully recruited by mid 2014.
Preliminary data is expected to be released by November 2014.
The study is designed to generate safety and efficacy data of BIT225 when administered over a three month period in patients infected with Hepatitis C genotypes 1 or 3.
It will use the new capsule formulation of BIT225 that is expected to have an improved safety profile and ease of use compared to the previous powder formulation.
Biotron’s BIT225 compound is the first in a new class of direct acting antiviral drugs for Hepatitis C. It specifically targets the p7 protein, which is involved in virus assembly.
The previous BIT225 study in HCV patients focused on a four week dosing regimen. Phase 2a data demonstrated that 100% of trial subjects who received BIT225 (400mg) over four weeks had undetectable levels of virus in the blood at the 48 week follow up. This was compared to 75% of patients who received standard of care alone.
The Hepatitis C global market is currently estimated at US$3.3 billion, but is expected to expand to over US$15 billion as safe, effective therapies enter the market.
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