Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, has announced successful final results from its Phase I/II study for BL-7010, a novel co-polymer for the treatment of celiac disease.
Subscribe to our email newsletter
BL-7010 was found to be safe and well tolerated in both single- and repeated-dose administrations, and the optimal safe dose for future development was determined. Over the next few months, the Company will conduct additional non-clinical studies and formulation development for BL-7010 in preparation for the upcoming randomized, placebo-controlled efficacy study, which BioLineRx expects to commence in the second half of 2015.
In all single- and repeated-administration cohorts, pharmacokinetic analyses revealed no systemic exposure of BL-7010 in plasma and urine samples. Based on previous communications with a Notified Body in the European Union, the lack of systemic exposure will likely support a medical-device classification for BL-7010, which would significantly accelerate its development in Europe.
Based on its strong safety and tolerability profile, BioLineRx has selected the one gram, three times per day regimen of BL-7010 as the optimal repeated dose for the upcoming efficacy study. Decreasing the dose to these levels substantially reduced the gastrointestinal (GI)-related adverse events (primarily diarrhea) observed previously at higher doses, while remaining within the anticipated therapeutic window for BL-7010 based on non-clinical studies.
Dr. Kinneret Savitsky, CEO of BioLineRx, said, "BL-7010 for the treatment of celiac disease is one of our lead clinical programs, and we are very pleased with the positive final results of this Phase 1/2 safety study of BL-7010, and the determination of the optimal safe dose for continued development. We are also very encouraged that the results further support previous non-clinical data showing that BL-7010 is not absorbed systemically. This will most likely support an expedited development pathway for the product in Europe."
"Celiac disease is highly prevalent throughout the world, with over 1% of the global population suffering from this disease. Nevertheless, there are currently no approved celiac therapies aside from a strict and lifelong gluten-free diet, which is exceptionally difficult and costly to maintain. Despite the significant need for new treatments, there are only a handful of clinical-stage projects under development worldwide for this disease, which we view as a significant opportunity for our product," concluded Dr. Savitsky.