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news.BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it will present positive safety results of its Phase 1/2 study for BL-7010, a novel polymer for the treatment of celiac disease, at the 16th International Celiac Disease Symposium (ICDS 2015), to take place from June 21-24 in Prague, Czech Republic.
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The Phase 1/2 results were previously announced in November 2014.
Yotam Nisemblat, BioLineRx Drug Development Director, will present the data in a talk titled BL-7010, a Novel Potential Treatment of Celiac Disease – a Phase 1/2 Safety Study in Celiac Patients, on Wednesday, June 24, in the Novel Treatments session.
BL-7010 was found to be safe and well tolerated in the single-dose phase, and the optimal safe dose for future development was determined in the repeated-dose phase.
The Company is in the final stages of additional non-clinical studies and formulation development for BL-7010 in preparation for the upcoming randomized, placebo-controlled efficacy study, which is expected to commence in the fourth quarter of 2015.
BL-7010 is a novel, non-absorbable, orally available co-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. 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 safety and efficacy of BL-7010 have been demonstrated in pre-clinical studies. BL-7010 was invented by Prof. Jean-Christophe Leroux from the Department of Chemistry and Applied Biosciences, Institute of Pharmaceutical Sciences, ETH Zurich, Switzerland, and is being developed by BioLineRx under a worldwide exclusive license agreement with Univalor.