BioLineRx starts enrollment in Phase I/II trial of BL-8020 for treatment of HCV

BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today enrollment of the first patient in a Phase I/II trial for BL-8020, an orally available, interferon-free treatment for the Hepatitis C virus (HCV). The patient was enrolled at the Hôpital Cochin in Paris, France.

“We are also excited about the initiation of the Phase I/II clinical trial with BL-8020”

The study is an open-label trial to evaluate the efficacy, safety and tolerability of BL-8020 in patients infected with HCV. It will be conducted at two clinical sites in France and will include up to 32 HCV-infected patients of any genotype who have previously failed or relapsed following treatment with the standard-of-care. BL-8020 is a proprietary fixed-dose combination treatment composed of Ribavirin and Hydroxychloroquine (HCQ), which results in an improved version of Ribavirin. The primary endpoint of the study is to evaluate the effect of a 16-week combination therapy with Ribavirin and HCQ. The study is specifically designed to allow intra-subject analysis, in order to determine the extent to which HCQ enhances Ribavirin's antiviral activity.

BL-8020 is an orally available HCV treatment with a unique mechanism of action that targets the host cell, and thus differs from other currently used anti-HCV agents. This suggests pan-genotypic efficacy and the ability to be combined with other HCV therapeutics as part of an interferon-free regimen. BL-8020's mechanism of action involves the inhibition of HCV-induced autophagy in the host cells. Autophagy is a mechanism by which cells degrade damaged or unnecessary cellular components, and is known to be used by HCV during viral replication. BL-8020 inhibits the autophagy mechanism and thus reduces the ability of HCV to replicate in the human cell.

BL-8020's safety and efficacy have been demonstrated in a number of pre-clinical studies. These studies have shown that BL-8020 has a synergistic effect with other anti-HCV agents. This effect on other therapies is likely to increase their potency and reduce the numerous adverse effects often associated with these drugs by enabling utilization of lower dosages. The use of multiple therapies with different modes of action is also likely to be beneficial for patients who have developed resistance or do not respond to current treatments and is a common practice in current HCV treatment regimens.

"We are very pleased with the initiation of a clinical trial for our first anti-HCV agent, BL-8020. HCV induces a chronic infection in over one-half of individuals infected and, depending on the virus genotype, as few as 60% completely recover. In addition, current standard-of-care treatment options are lengthy and not well tolerated," stated Dr. Kinneret Savitsky, CEO of BioLineRx. "Accordingly, there is a clear need for new drugs that can increase the effectiveness of existing treatments, especially in patients who have already undergone treatment, but have previously failed to respond or relapsed. In this respect, this study would be a first step in establishing in patients the synergistic potential of BL-8020 in combination with other HCV treatments. Based on its pre-clinical results, unique mechanism of action and synergistic effect with other anti-HCV compounds, we are very hopeful that BL-8020 will indeed enhance the activity of other available Hepatitis C treatments, thereby improving Hepatitis C care. We look forward to the partial results from the Phase I/II trial expected towards the end of 2013."

"We are also excited about the initiation of the Phase I/II clinical trial with BL-8020," stated Professor Stanislas Pol from Hôpital Cochin in Paris, the lead principal investigator in the study. "Preclinical results in our ex-vivo model of infected human liver slices showed a time and dose-dependent inhibitory effect on HCV replication and infectivity. We hope that this drug, especially when combined with other available Hepatitis C drugs, will improve the treatment outcome of previously non-responsive patients," said Professor Pol.