BioLineRx has announced that the Company’s novel treatment for celiac disease, BL-7010, has successfully completed the single administration, dose-escalation stage of the on-going Phase 1/2 clinical study. No serious adverse events were reported and there were no dose-limiting safety issues.
Based on these positive safety and tolerability results, the Company will proceed with the repeated administration stage of the study. Results are expected in mid-2014.
The Phase 1/2 study, taking place at Tampere Hospital in Finland, a world-leading site for celiac disease research, is a two-part (single and repeated administration), double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 24 well-controlled celiac patients.
The primary objective of the study is to assess the safety of single and repeated ascending doses of BL-7010 in the study patients. Secondary objectives include an assessment of the systemic exposure, if any, of BL-7010 in the 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, and although the study remains blinded at this point, no serious or dose-limiting adverse events were reported and all planned doses were found to be safe and well-tolerated.
Consequently, all patients completed their participation in this part of the study. Based on these encouraging safety and tolerability results, the study will now progress to the repeated administration stage, in which each patient will receive either BL-7010 or placebo for 14 days, three times per day.
“BL-7010 for the treatment of celiac disease is one of our lead development programs, and we are 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,” said Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx.
Dr. Savitsky continued, “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.”
“Celiac disease is highly prevalent throughout the world, with over 1% of the global population suffering from this disease. Nevertheless, there are currently no approved celiac therapies aside from a strict and lifelong gluten-free diet, which is exceptionally difficult and costly to maintain. Despite the significant need for new treatments, there are only a handful of clinical-stage projects under development worldwide for this disease, which we view as a significant opportunity for our product,” concluded Dr. Savitsky.