BioLineRx Files Regulatory Submissions To Begin Phase 1/2 Trial For BL-7010

(RTTNews) - BioLineRx (BLRX) announced Tuesday that it has filed the necessary regulatory submissions to commence a Phase 1/2 trial for BL-7010 - for the treatment of celiac disease - with the Finnish National Supervisory Authority for Welfare and Health (Valvira). The relevant ethics committee has already approved commencement of the study.

According to the company, the Phase 1/2 study is a two-part (single and repeated), double-blind, placebo-controlled, dose escalation study of BL-7010 in 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. The CRO and data management vendors have already been selected for the study, which is expected to start in the fourth quarter of this year.

"We look forward to commencing the Phase 1/2 clinical study for BL-7010 by the end of the year. The study will be conducted in Finland, which has a significantly higher prevalence of celiac disease than other countries and is a world leader in celiac research," stated Kinneret Savitsky, Chief Executive Officer of BioLineRx.

BL-7010 is a novel, non-absorbable, orally available polymer intended for the treatment of celiac disease. It has a high affinity for gliadins, the immunogenic proteins present in gluten that cause celiac disease. By sequestering gliadins, BL-7010 effectively masks them from enzymatic degradation and prevents the formation of immunogenic peptides that trigger the immune system.

Celiac disease is a chronic, autoimmune, inflammatory disease of the small intestine characterized by damage to the lining of the small intestine and typically leads to dyspepsia, malabsorption and a variety of other symptoms. It occurs in genetically predisposed individuals and is caused by an immunological reaction to gluten, found in wheat, barley and rye. The celiac market is projected to reach $8 billion by 2019.