BioLineRx has received European Notified Body confirmation of BL-7010, a polymer for the treatment of coeliac disease, as a class IIb medical device
BL-7010 is a novel, non-absorbable, orally available co-polymer intended for the treatment of coeliac disease.
Kinneret Savitsky, chief executive officer of BioLineRx, said: "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-coeliac gluten sensitivity population is approximately 10 times larger than the coeliac population.
“In addition, the time to market is significantly shorter for food supplements compared to prescription drugs or devices."