For immediate release
BioLineRx Receives Confirmation of Medical Device
Classification in Europe for Celiac Treatment
- BL-7010 receives designation as Class IIb medical device -
Tel Aviv, Israel, January 25, 2016 - BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has received confirmation regarding the classification of BL-7010, a novel polymer for the treatment of celiac disease, as a Class IIb medical device in the European Union.
Kinneret Savitsky, Ph.D., Chief Executive Officer of BioLineRx, commented, “We are very excited to receive confirmation for the medical device designation pathway in Europe for our BL-7010 program. We are now preparing the next steps in the development of this product, including the next clinical efficacy study which we expect to commence in mid-2016.”
“In parallel, we are also continuing to evaluate the potential of BL-7010 as a food supplement. This evaluation is based on the fact that the non-celiac gluten sensitivity population is approximately 10 times larger than the celiac
population. In addition, the time to market is significantly shorter for food supplements compared to prescription drugs or devices,” added Dr. Savitsky.
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 a number of pre-clinical studies. In addition, BL-7010 was found to be safe and well tolerated in a Phase 1/2 study completed in November 2014. 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.