Biotron completes recruitment for BIT225 trial
Biotron (ASX:BIT) has completed enrolment for a phase II trial of BIT225 as a treatment for hepatitis C.
The company has now enrolled 60 patients with HCV genotypes 1 or 3 at six trial sites in Thailand.
The three-month dosing study will seek to add to the efficacy data for the drug while further establishing its safety and tolerability profile in longer-term dosing.
Patients will receive 200 mg of the new capsule formulation of BIT225 twice daily for three months in combination with standard of care therapies interferon and ribavirin (IFN/RVB), and will continue to receive the standard of care out to 24 weeks for genotype 3 patients and 48 for genotype 1.
An earlier phase II study in co-infected HIV and HCV genotype 3 patients showed that 100% had undetectable levels of HCV 12 weeks after completing the BIT225 and IFN/RVM combination therapy.
A phase IIa trial in HCV genotype 1 patients likewise found that 100% of patients in receiving the highest 400 mg dose of BIT225 in combination with IFN/RVB had undetectable HCV levels at the 48-week point.
“Despite recent advances in treatment of HCV, significant treatment gaps remain, in particular for genotype 3,” Biotron Managing Director Dr Michelle Miller commented.
“We look forward to progressing commercialisation of BIT225 as a valuable new therapy that will work in combination with current and future treatment strategies.”
Biotron (ASX:BIT) shares were trading 8.25% higher at $0.10 as of around 12.30 pm on Wednesday
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