Biotron completes recruitment for Phase 2 Hepatitis C trial
THE ROADHOUSE PHARMACY: Biotron Limited (ASX: BIT) has completed patient enrolment for a Phase 2 trial, which will evaluate lead compound BIT225 as a potential new therapy for the treatment of Hepatitis C virus (HCV) infection.
A total of 60 patients infected with HCV genotypes 1 or 3 (G1, G3) has been recruited at six established trial sites in Thailand for the randomised, placebo controlled three-month dosing study (Protocol BIT225-008).
Biotron said the trial has been designed to extend efficacy data against HCV G1 and G3, and to provide further confirmation of BIT225’s safety and tolerability profile in longer term dosing using the new capsule formulation of the drug.
The study extends the company’s previous study, which produced data was based on four week dosing regimes.
“It is important we provide further safety and efficacy data that demonstrates further safety and tolerability over 12 weeks,” Biotron Limited managing director Dr Michelle Miller said in the company’s announcement to the Australian Securities Exchange.
“If successfully developed, BIT225 will most likely be used in combination with other new classes of direct-acting antiviral (DAA) drugs, which currently require a minimum dosing period of 12 weeks.
“Safety and antiviral efficacy data to date has been extremely encouraging and we are confident this will be replicated in an extended dosing regime.”
Under trial protocols, patients are receiving 200 mg of BIT225 twice daily for three months in combination with current standard of care therapies – pegylated interferon alfa 2b (IFN) and ribavirin (RBV) before continuing to receive standard of care out to 24 weeks (genotype 3) or 48 weeks (genotype 1).
A previous Phase 2a study demonstrated that 100 per cent of HIV G1 patients who received BIT225 (400 mg) over four weeks in conjunction with standard of care therapies had undetectable levels of virus at the 48 week follow up.
This was compared to 75 per cent of patients who received standard of care alone.
BIT225 also showed good efficacy in a Phase 2 trial of BIT225/IFN/RBV in patients co-infected with HIV and HCV G3, with all patients who completed treatment having undetectable levels of HCV 12 weeks after ceasing all treatment, which Biotron said is an indication that they were cured of HCV infection.
“Despite recent advances in treatment of HCV, significant treatment gaps remain, in particular for genotype 3,” Dr Miller said.
“We look forward to progressing commercialisation of BIT225 as a valuable new therapy that will work in combination with current and future treatment strategies.”
Website: www.biotron.com.au