Biotron Ltd
(ASX:BIT) has confirmed positive outcomes from its Phase 2 study of its
first-in-class antiviral drug BIT225 for the treatment of Hepatitis C
virus.
The placebo-controlled, randomised three month study of the safety, pharmacokinetics and antiviral activity of BIT225 for patients infected with the Hepatitis C virus (HCV G1) achieved its main endpoints evaluating safety and efficacy.
It also included assessment of the assessing antiviral activity and pharmacokinetics of the new capsule formulation.
The trials, being conducted at several trial sites in Thailand, showed that HCV G1 patients treated with BIT225 and IFN/RBV are significantly more likely to clear virus within 24 weeks of commencing treatment than those treated with IFN/RBV alone.
HCV G1 is the most common Hepatitis C infection accounting for approximately 70% to 75% of all Hepatitis C infections. The combination of IFN and RBV is the most common therapy to treat HCV G1.
The results are encouraging in that after 12 weeks after stopping BIT225 treatment, 82% of HCV G1 patients treated with a combination of BIT225 and IFN/RBV were clear of virus, compared to 60% of those treated with IFN/RBV alone.
BIT225 proved to be safe and well-tolerated with none of the HCV G1 patients withdrawing due to BIT225-related adverse events.
The trial has provided key data on the performance of the capsule formulation of BIT225, which is central to future studies with the drug.
Further analysis of the trial data is ongoing, and the Biotron aims to present detailed data at a scientific conference later in 2016.
The placebo-controlled, randomised three month study of the safety, pharmacokinetics and antiviral activity of BIT225 for patients infected with the Hepatitis C virus (HCV G1) achieved its main endpoints evaluating safety and efficacy.
It also included assessment of the assessing antiviral activity and pharmacokinetics of the new capsule formulation.
The trials, being conducted at several trial sites in Thailand, showed that HCV G1 patients treated with BIT225 and IFN/RBV are significantly more likely to clear virus within 24 weeks of commencing treatment than those treated with IFN/RBV alone.
HCV G1 is the most common Hepatitis C infection accounting for approximately 70% to 75% of all Hepatitis C infections. The combination of IFN and RBV is the most common therapy to treat HCV G1.
The results are encouraging in that after 12 weeks after stopping BIT225 treatment, 82% of HCV G1 patients treated with a combination of BIT225 and IFN/RBV were clear of virus, compared to 60% of those treated with IFN/RBV alone.
BIT225 proved to be safe and well-tolerated with none of the HCV G1 patients withdrawing due to BIT225-related adverse events.
The trial has provided key data on the performance of the capsule formulation of BIT225, which is central to future studies with the drug.
Further analysis of the trial data is ongoing, and the Biotron aims to present detailed data at a scientific conference later in 2016.
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