BioLineRx (NASDAQ:BLRX) advanced in early trading after the clinical-stage biopharmaceutical company received confirmation of a medical device classification in Europe for its celiac treatment BL-7010.
Shares gained as much as 4.9% as of 8:30 a.m. in New York. The stock has lost half its value over the past six months to close at $1.03 on Friday.
BL-7010 was confirmed by the European Notified Body as a Class IIb medical device in the European Union, the Israel-based company said in a statement on Monday.
"We are very excited to receive confirmation for the medical device designation pathway in Europe for our BL-7010 program, CEO Kinneret Savitsky said in the statement.
The company said it expects to commence the next clinical efficacy study in mid-2016.
"In parallel, we are also continuing to evaluate the potential of BL-7010 as a food supplement,” Savitsky said. “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.
Celiac disease is a chronic, autoimmune, inflammatory disease of the small intestine characterized by damage to the lining of the small intestine and typically leads to dyspepsia, malabsorption and a variety of other symptoms.
It occurs in genetically predisposed individuals and is caused by an immunological reaction to gluten, found in wheat, barley and rye.
There are currently no treatments approved for celiac disease and the only treatment option is a life-long, strict, gluten-free diet, which is difficult to maintain both due to food contamination with gluten, as well as eating habits in a social setting.