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Celiac.com 12/09/2014 - Biopharmaceutical company BioLineRx Ltd., has announced successful final results from its Phase 1/2 study for BL-7010, a novel co-polymer for the treatment of celiac disease. BL-7010 is a new, non-absorbable, orally available co-polymer intended for the treatment of celiac disease. The drug works by sequestering gliadins, effectively masking them from enzymatic degradation and preventing the formation of immunogenic peptides that trigger an adverse immune reaction when people with celiac disease consume wheat. This significantly reduces the immune response triggered by gluten. BL-7010 is excreted with gliadin from the digestive tract and is not absorbed into the blood. The trial results showed BL-7010 to be safe and well tolerated in both single- and repeated-doses, and pharmacokinetic analyses revealed no systemic exposure of BL-7010 in plasma and urine samples. The company has also settled on a one gram, three times per day regimen of BL-7010 as the optimal repeated dose for an upcoming randomized, placebo-controlled efficacy study set to begin in the last half of 2015. The absence of systemic exposure will likely support a medical-device classification for BL-7010, which would significantly accelerate its development in Europe. Source: Marketwatch.com
Celiac.com 01/31/2014 - Drug company BioLineRx has announced trials of BL-7010, a drug for treating celiac disease. BL-7010 is a new, non-absorbable, orally available polymer with a high affinity for gliadins, the immunogenic proteins present in gluten that cause celiac disease. BL-7010 is intended to treat celiac disease by sequestering and effectively masking gliadins from enzymatic degradation and preventing the formation of immunogenic peptides that trigger the classic adverse immune reaction. The BL-7010 is then excreted with gliadin from the digestive tract, preventing the absorption of gliadin into the blood. The overall effect is to significantly reduce the immune response triggered by gluten. According to BioLineRX, pre-clinical studies have shown BL-7010 to be both safety and effective. BioLineRX's Phase 1/2 study is a two-part, both single and repeated, double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 32 patients. The main goal is to gauge the safety of single and repeated increasing doses of BL-7010 in well-controlled celiac disease patients. They also hope to assess the results of systemic exposure, if any, of BL-7010 in the study patients. Source: Wall Street Journal Online