intestine

BioLineRx has completed the dose-escalation stage of the ongoing Phase I/II clinical study for BL-7010, a non-absorbable, orally available polymer intended for treatment of celiac disease.

According to the company, single administration of BL-7010 was safe and well-tolerated at all doses tested. No dose-limiting safety issues and no serious adverse events have been reported.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

BioLineRx will proceed with the repeated administration stage based on these encouraging safety and tolerability results, where each patient will receive either BL-7010 or placebo for 14 days, three times daily. Results are expected in mid-2014.

The Phase I/II study, taking place at Tampere Hospital in Finland, is a two-part (single and repeated administration) double-blind, dose escalation study of BL-7010 in up to 24 well-controlled celiac patients.

The primary objective of the placebo-controlled study is to evaluate the safety of single and repeated ascending doses of BL-7010, while secondary objectives include an assessment of the systemic exposure, if any, of BL-7010 in the study patients.

See Also:

"We expect to report the full results of the current Phase 1/2 study in mid-2014 and assuming they are successful, we expect to commence a randomised, controlled efficacy study in celiac patients by the end of this year."

In the first part of the study, there was evaluation of six dose levels of BL-7010 compared with placebo. The escalation stage reached the highest planned dose.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

BioLineRx CEO Dr Kinneret Savitsky said: "BL-7010 is a unique and very promising product, with excellent pre-clinical efficacy and safety results. We expect to report the full results of the current Phase 1/2 study in mid-2014 and assuming they are successful, we expect to commence a randomised, controlled efficacy study in celiac patients by the end of this year."

BL-7010 was invented by Dr Jean-Christophe Leroux from ETH Zurich, Switzerland, Institute of Pharmaceutical Sciences department of Chemistry and Applied Biosciences. It has a high-affinity for gliadins, the immunogenic proteins present in gluten that cause celiac disease.

The drug, by sequestering gliadins, effectively masks gliadins 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, preventing absorption of gliadin into the blood.

The drug is being developed by BioLineRx under a worldwide exclusive license agreement with Univalor. Safety and efficacy of BL-7010 was demonstrated in pre-clinical studies.

Image: Celiac disease is a chronic, autoimmune, inflammatory disease of the small intestine. Photo: courtesy of Freedigitalphotos.net.