BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today 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.
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 Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx. "We are very enthusiastic about this unique product, which is generating a lot of excitement from both the scientific and medical communities. Despite the unmet medical need and the huge size of the celiac market, there is no available treatment for the disease apart from a lifelong gluten-free diet, which is extremely difficult to maintain. Since there are also very few products currently in clinical-stage development, we see a significant opportunity in this market for our product."