NEW YORK, March 17, 2016 /PRNewswire/ -- Biotron Limited (ASX: BIT) confirms positive outcomes from its Phase 2 study of its first-in-class antiviral drug BIT225.
The trial was designed to assess the safety and antiviral activity of three month's dosing of BIT225 in patients infected with Hepatitis C virus (HCV). In addition, the trial provided key information on a new capsule form of BIT225, information that is critical for determining dosage in further studies with the drug.
Key outcomes from analysis of the 30-subject HCV genotype 1 (G1) cohort:
- BIT225 was safe and well-tolerated with none of the HCV G1 patients withdrawing due to BIT225-related adverse events.
- 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.
- 12 weeks after stopping BIT225 treatment, 82% of HCV G1 patients treated with BIT225+IFN/RBV were clear of virus, compared to 60% of those treated with IFN/RBV alone.
- The trial has provided key data on the performance of the capsule formulation of BIT225, which is central to future studies with the drug.
Biotron's Managing Director, Dr Michelle Miller, remarked: "We are delighted with the outcome of this trial of a new class of pan-genotypic anti-HCV drug. The safety profile of BIT225 in these HCV G1 patients was excellent, and the drug had a clear beneficial antiviral effect over and above the standard of care IFN/RBV."
"The data supports a potential role for BIT225 to be used in combination with new HCV drugs that have recently entered the market to shorten patient treatment times and improve treatment outcomes. We continue to explore licensing opportunities for BIT225 and HCV."
"The safety and capsule formulation data from this trial can be used to support an upcoming Phase 2 trial in patients infected with HIV-1, against which the drug is also active. This is anticipated to start in mid-2016."
The trial was a multi-centre, placebo-controlled, randomised study of the safety, pharmacokinetics and antiviral activity of BIT225. The trial achieved its two primary endpoints evaluating safety and efficacy, as well as its secondary endpoints, including assessment of the assessing antiviral activity and pharmacokinetics of the new capsule formulation. The study was conducted at several clinical trial sites in Thailand.
Analysis of the trial data is ongoing, and the Company aims to present detailed data at a scientific conference later in 2016.
Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need, with a major focus on HIV and HCV. The Company has BIT225 in clinical development for both HIV and HCV, and also has several earlier stage preclinical and research programs for several other viral infections including Dengue.
Dr Michelle Miller
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SOURCE Biotron Limited