This patent, when issued, will be valid until at least 2026. Additional patents claiming the BL-7010 composition and uses thereof are granted or pending in the US, Europe, Japan, Canada, Israel, India, China, Brazil, Russia, Australia, South Africa and Hong Kong.
"We are very pleased to receive this Notice of Allowance for the BL-7010 patent in the prevention of gluten toxicity, which significantly broadens our coverage in the United States," stated Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx. "We recently announced unblinded results of a Phase 1/2 safety study for BL-7010, in which the compound was shown to have no systemic exposure. This is of significance since it may support classification of BL-7010 as a medical device in Europe, accelerating its pathway to commercialization. We are currently in the final stages of the Phase 1/2 safety study in order to select the optimal dose of BL-7010 for the upcoming efficacy study, which we look forward to commencing early next year."
About BL-7010
BL-7010 is a novel, non-absorbable, orally available polymer intended for the treatment of celiac disease. It has a high affinity and specificity 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.