BioLineRx has announced the enrollment of the first patient in a Phase 1/2 trial of BL-7010, for the treatment of celiac disease. The first patient was enrolled at Tampere Hospital in Finland, a world-leading site for celiac disease research. Results are expected in mid-2014.
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.
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 systemic exposure, if any, of BL-7010 in the study patients.
"The commencement of BL-7010's Phase 1/2 study in a world-leading celiac treatment center is an important milestone in the development of one of our most promising projects," said Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx.
Dr. Savitsky continued, "Based on our pre-clinical results to date, we are very enthusiastic about this unique product, which is also generating a lot of excitement from both the scientific and medical communities. Celiac disease is an autoimmune condition that causes damage to the small intestine, and is associated with other autoimmune disorders, as well as with osteoporosis, infertility, neurological conditions and even cancer. Although 1% of the world's population suffers from this disease, there are currently no approved celiac therapeutics, and the only treatment available today is a gluten-free diet that is exceptionally difficult and costly to maintain. In addition, there are an extremely small number of clinical-stage projects under development worldwide for celiac disease, which we see as a significant opportunity for our product."
Dr. Savitsky concluded, "We anticipate 2014 to be a significant year for BioLineRx marked by several important milestones across our clinical-stage development programs, among which we are now pleased to include BL-7010. We are looking forward to the results of this Phase 1/2 safety study, expected in mid-2014, to be followed by an efficacy study that we hope to commence in the second half of 2014."