Hep C drug trial deemed a success

Shares in Biotron (ASX:BIT) rose almost 60% today as the biomedical research company confirmed positive outcomes from its Phase 2 study of antiviral drug BIT225 in Hepatitis C patients. Conducted at several clinical trial sites in Thailand, the Phase 2 trial was a multicentre, placebo-controlled, randomised study of the safety, pharmacokinetics and antiviral activity of BIT225.

The trial was designed to assess the safety and antiviral activity of three months’ dosing of BIT225 in patients infected with Hepatitis C virus (HCV), as well as to provide information on a new capsule form of the drug. BIT225 was found to be safe and well-tolerated by the HCV genotype 1 (G1) cohort that undertook the trial, with none of the 30 patients withdrawing due to BIT225-related adverse events.

Additionally, HCV G1 patients treated with BIT225 and interferon/ribavirin (IFN/RBV) were significantly more likely to clear virus within 24 weeks of commencing treatment than those treated with IFN/RBV alone. Twelve weeks after stopping 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.

“We are delighted with the outcome of this trial of a new class of pan-genotypic anti-HCV drug,” said Biotron Managing Director Dr Michelle Miller. “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.”

Though analysis of the data is still ongoing, the trial has already 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 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,” noted Dr Miller. “This is anticipated to start in mid-2016.”

Biotron (ASX:BIT) shares were trading 58.73% higher at $0.100 soon after the announcement was made this morning. They had lowered to $0.091 — still a substantial rise of 44.44% — as of around 4 pm.

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