HCV p7 inhibitor BIT225 posts strong EVR results....

...but is it viable in the new zeitgeist of interferon-free therapies?


Sydney-based Biotron (ASX:BIT) has presented encouraging results from a trial of the use of its prospective Hepatitis C treatment, when coupled with existing therapies.

Patients treated in a phase IIa trial of Biotron's BIT225 drug candidate, combined with approved standard of care (SOC) treatments, mostly demonstrated improvement at three month follow-up.

Of the subjects to have been treated with BIT225, 87% showed a complete early viral response (EVR) – defined as virus levels in the blood below the level of detection.

This compares to 63% who received only SOC treatments interferon alfa-2b plus ribavirin, and backs up data from the four week point of the study showing significantly reduced levels of HCV virus in BIT225-treated patients.

The extent of virus reduction was dose-dependent, with the higher dose having the most effect.

Patients involved in the trial received either 200mg or 400mg doses of BIT225 for 28 days, and then remained on the SOC treatments for another 44 weeks.

Biotron CEO Dr Michelle Miller said the results of the trial were “extremely encouraging.” She said they also show that BIT225 was generally well-tolerated in patients, with the most common potential side effect being nausea, which may be solved by tweaks to the formulation.

Biotron is also in the middle of a phase 1b/IIa trial for BIT225 as a treatment for HIV.

Biotron (ASX:BIT) shares climbed 18.18% to a seven-month high of $0.130 after the results were released on Wednesday.

Positive Phase 2a data for Biotron's first-in-class HCV p7 inhibitor BIT225...

Positive Phase 2a data for Biotron's first-in-class HCV p7 inhibitor BIT225

Biotron shares soar 34% on Hepatitis C Phase 2a positive results
Monday, October 10, 2011 by John Phillips

Biotron Limited (ASX: BIT) has received some strong support in the first couple of hours of market open today, with the stock trading 34% higher at $0.13 after announcing some positive trial results.

Preliminary analysis of trial data confirms that BIT225, an orally administered, small molecule drug, has good antiviral activity against HCV.

Patients receiving BIT225 in combination with interferon and ribavirin (the current standard of care for treating HCV) had greater reductions in HCV levels than patients receiving standard of care treatment alone.

Biotron said that patients receiving the 400 mg dose of BIT225 showed the greatest levels of virus reduction, with an improvement of ~1 log (a measure of the amount of reduction of the virus in the blood of patients) over standard of care treatment at the completion of the dosing phase with BIT225.

This is a significant improvement over and above the standard of care treatment in this patient group.

Twenty four patients who had passed a stringent screening process were randomly assigned to receive either 400 mg or 200 mg BIT225, or placebo (ratio of 1:1:1), for the first 28 days of their standard treatment with interferon and ribavirin.

The trial was undertaken at the Siriraj Hospital, Bangkok, Thailand.

All patients were infected with genotype 1 HCV, which is the most common type of HCV and the most resistant to current treatment.