Biotron's HCV Drug Clears All Symptoms In Patients

Australia-based drug development firm Biotron reported positive results from the Phase 2 trial of its lead antiviral agent BIT225 for the treatment of patients with hepatitis C virus (HCV).

BIT225 is a viroporin inhibitor being developed for the treatment of HCV and HIV. In a previous Phase 1B/2A trial, the drug has been shown to target viral replication of HIV in in patients who have undergone treatment.

In the open label pilot study, BIT225 met the primary endpoint of sustained virologic response (SVR) in all five patients with HCV genotype 3 virus. All patients had undetectable levels of the virus at 12 weeks after completing treatment. Biotron stated in its press release, “Although the number of patients in the trial is small, the fact that 100 percent had no HCV detected from week 12 onwards is encouraging evidence of efficacy of BIT225.” The trial, which was conducted in Thailand, also evaluated safety and tolerability as well as pharmacokinetics and antiviral efficacy.

Biotron Managing Director Dr Michelle Miller said, “These SVR12 data support the efficacy of BIT225 as a potential new therapy for HCV and, in particular, for this difficult to treat group of HIV/HCV co-infected patients who typically have more serious HCV infection and fewer treatment options... We look forward to progressing commercialization of BIT225 as a valuable new therapy that will work in combination with current and future treatment strategies.”

Biotron reported that a three-month dosing Phase 2 trial is currently underway and is evaluating BIT225 in combination with standard of care HCV drugs interferon and ribavirin (IFN/RBV) in HCV genotype 1 and genotype 3 patients. Results from the ongoing trial are expected to be released before the end of the year.

Dr. Miller noted that that HIV and HCV treatments represent multi-billion dollar markets, which could set the company up to reap a greater share in the market. Indeed, the company’s shares rocketed to over 70 percent with the news of BIT225’s success, the Australian Business Review reports.