No dose-limiting safety issues and no serious adverse events have been reported in the dose-escalation stage. Based on these encouraging safety and tolerability results, BioLineRx will proceed with the repeated administration stage, in which each patient will receive either BL-7010 or placebo for 14 days, three times per day. Results are anticipated in mid-2014.
The Phase I/II study, which is being conducted at Tampere Hospital in Finland, is a two-part (single and repeated administration) double-blind, dose escalation study of BL-7010 in up to 24 well-controlled celiac patients.
Primary objective of the placebo-controlled study is to evaluate the safety of single and repeated ascending doses of BL-7010, while secondary objectives include an assessment of the systemic exposure, if any, of BL-7010 in the study patients.
During the first part of the study, six dose levels of BL-7010 were evaluated compared to placebo. The escalation stage reached the highest planned dose.
BioLineRx CEO Dr Kinneret Savitsky noted BL-7010 for the treatment of celiac disease is one of the company’s lead development programs, and it is very happy to see that it is safe and well tolerated – even at very high doses that are significantly above the expected clinical efficacious dose.
"BL-7010 is a unique and very promising product, with excellent pre-clinical efficacy and safety results. We expect to report the full results of the current Phase 1/2 study in mid-2014 and assuming they are successful, we expect to commence a randomized, controlled efficacy study in celiac patients by the end of this year," Savitsky added.
Safety and efficacy of BL-7010 was demonstrated in pre-clinical studies.
BL-7010 was invented by Dr Jean-Christophe Leroux from ETH Zurich, Switzerland, Institute of Pharmaceutical Sciences department of Chemistry and Applied Biosciences. The drug is being developed by BioLineRx under a worldwide exclusive license agreement with Univalor.