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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 from the European Notified Body 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.
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.
