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.
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.
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.
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.