Data from BioLineRx’s BL-7010 pre-clinical studies on celiac disease

BioLineRxSep 10 2012

BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that BL-7010, an orally available treatment for celiac disease, was found to be safe and well tolerated in pre-clinical studies conducted to date. The new findings were delivered in an oral presentation by Professor Elena Verdú, Division of Gastroenterology, Department of Medicine, McMaster University, Hamilton, Ontario, at the Better Life for Coeliacs 2012 Conference, held in Helsinki, Finland from September 6^th-9^th. In her talk, Prof. Verdú also presented previously disclosed pre-clinical data demonstrating that BL-7010 reduces gluten toxicity, which were published in the in leading medical journal Gastroenterology.    

In pre-clinical studies BL-7010 was found to be safe, well tolerated and did not cause any clinical adverse effects, even in very high doses. Additional studies showed that BL-7010 is specific to gliadins, the immunogenic peptides present in gluten that cause celiac disease, and does not interact with non-related enzymes or vitamins in the digestive tract. These results imply that BL-7010 will not affect the absorbance of vitamins or the digestion process and therefore will not lead to malnutrition.

"These new findings for BL-7010, in addition to the pre-clinical efficacy data are very encouraging, especially since BL-7010 was found to be safe and without adverse effects in laboratory animals even in doses much higher than the expected clinically effective dose. Currently, the only effective treatment for celiac is a gluten free diet, which is extremely difficult to maintain, and significantly affects the quality of life of people with celiac disease. Therefore, there is a critical need for developing a safe and effective drug that could help, alongside the dietary restrictions, in preventing damage caused to the digestive tract by gluten," said Professor Elena Verdú, who presented the data. "BL-7010 may attenuate the immune response to gluten and reduce subsequent damage to the small intestine, and may therefore be an effective adjuvant therapy that will improve the quality of life for people with celiac disease throughout the world."

Additional efficacy studies indicate that BL-7010 reduces digestion of wheat gluten, thereby decreasing its toxicity. In addition, BL-7010 attenuates the immune response to gluten in rodents and prevents gluten-induced pathological damage to the small intestine. BL-7010 is not absorbed systemically, indicating its safety as a gluten-neutralizing substance. These data demonstrate that BL-7010 has the potential to be an effective adjunctive therapy to the gluten-free diet, to prevent or reduce gluten-induced disorders in humans.