Pipeline Update at BioLineRx - Analyst Blog

Pipeline updates are highly awaited events for investors in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These companies spend a significant amount in advancing their pipelines.

One such biopharma company is BioLineRx BLRX whose pipeline includes candidates like BL-8040 (acute myeloid leukemia (AML) and other hematological cancer indications, currently in a phase II study), BL-5010 (non-surgical removal of skin lesions, a pivotal CE-mark registration trial to start in the first half of 2014), BL-1040 (preventing pathological cardiac remodelling following a myocardial infarction, currently in a pivotal CE-Mark registration trial) and BL-7010 (for celiac disease, currently in a phase I/II study).

Recently, BioLineRx announced the successful completion of the single administration, dose-escalation stage of the ongoing phase I/II study on BL-7010. BL-7010 is being evaluated for the treatment of celiac disease. The results showed positive safety and tolerability levels. There were no dose-limiting safety issues and serious adverse events found.

The repeated administration stage of the study will soon be initiated. In this stage of the study, patients will receive either BL-7010 or placebo thrice per day for a period of two weeks. Results from the phase I/II study will be out in mid-2014. Assuming successful completion of this study, BioLineRx expects to conduct a randomized, controlled, efficacy study at the end of this year, in patients suffering from celiac disease. 

In the ongoing double-blind, placebo-controlled, dose escalation, two-part study, the primary endpoint is the evaluation of the safety of single and repeated ascending doses of BL-7010 in well-controlled celiac patients. The secondary endpoint is the assessment of systemic exposure of BL-7010 in these patients.

We note that BL-7010 is developed by BioLineRx under a worldwide exclusive license agreement with Univalor.

BioLineRx carries a Zacks Rank #2 (Buy). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Questcor Pharmaceuticals, Inc. QCOR, Shire SHPG and Alkermes ALKS, all of which carry a Zacks Rank #1 (Strong Buy).