BioLineRx Receives Regulatory Approval to Commence Phase 1/2 Trial for BL-7010
News Nov 11, 2013
BioLineRx has announced that it has received regulatory approval from the Finnish National Supervisory Authority for Welfare and Health (Valvira) to commence a Phase 1/2 safety trial for BL-7010, for the treatment of celiac disease. The study is expected to begin by the end of this year.
The Phase 1/2 study is a two-part (single and repeated), double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 32 patients at a world-leading site for celiac disease research in Finland.
The primary objective of the study is to assess the safety of single and repeated ascending doses of BL-7010 in well-controlled celiac patients.
Secondary objectives include an assessment of the systematic exposure, if any, of BL-7010 in the study patients.
Professor Markku Maki, M.D., Ph.D., of the University of Tampere School of Medicine and the Tampere Center for Child Health Research in Finland, the responsible coordinating investigator of the trial, stated, "Celiac has become an increasingly problematic condition, with 1% of the world's current population suffering from this disease. The incidence of celiac is also expected to increase substantially in the future, with increased awareness and improved diagnostic tools. Despite the unmet medical need, the only current treatment is life-long adherence to a gluten-free diet, which is extremely difficult to maintain. Research results show that even up to 50% of patients on a gluten-free diet are still symptomatic and that small intestinal mucosal injury persists despite attempts to adhere to the diet."
Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, said "BL-7010 is a significant opportunity for us, considering there are no approved treatments for celiac disease and there are very few clinical-stage projects worldwide currently being developed for this disease. We look forward to commencing the Phase 1/2 safety study for BL-7010 by the end of the year, followed by an efficacy study, which we hope to commence in the second half of 2014."