Celiac.com 02/04/2016 - BL-7010, a non-absorbable, orally available co-polymer for the treatment of celiac disease, has received designation as Class IIb medical device in the European Union, according to manufacturer BioLineRx Ltd.
This designation clears path for BioLine’s BL-7010 program, and allows the company to plan the next steps in the development of a commercial version of BL-7010.
The safety and efficacy of BL-7010 have been demonstrated in a number of pre-clinical studies, including a Phase 1/2 study completed in November 2014.
In prepared comments, BioLineRX CEO Kinneret Savitsky, Ph.D., said that the company is "excited to receive confirmation for the medical device designation pathway in Europe for our BL-7010 program," and is now planning the next steps in the development of this product, including the next clinical efficacy study which we expect to commence in mid-2016."
The company also continues to "evaluate the potential of BL-7010 as a food supplement," said Dr. Savitsky.
Read more at: PRNewswire.