BioLineRx (BLRX) has made regulatory submissions to the Finnish National Supervisory Authority for Welfare and Health (Valvira) for initiating a phase I/II study on the company’s candidate BL-7010. The candidate is being developed for the treatment of celiac disease.
BioLineRx expects to initiate the two-part (single and repeated), double-blind, placebo-controlled, dose escalation study by year end. The company intends to enrol 32 patients for the study. The study will primarily evaluate the safety of single and repeated ascending doses of BL-7010. Results should be out in mid-2014. BioLineRx mentioned in its press release that the celiac market is expected to reach $8 billion by 2019.
BioLineRx has progressed well on its pipeline in recent times. Earlier this month, the company’s pipeline candidate BL-8040 was granted orphan drug designation by the U.S. Food & Drug Administration (:FDA) in the acute myeloid leukemia (:AML) indication.
BioLineRx’ BL-8040 is currently in a phase II study for the treatment of AML. BioLineRx is also evaluating BL-8040 for the treatment of thrombocytopenia (reduced platelet production). Last month the company reported positive results from pre-clinical trials on the candidate, where it was proved to be effective for the treatment of thrombocytopenia.
Apart from BL-7010 and BL-8040, BioLineRx also has BL-5010 (skin lesions), BL-7040 (inflammatory bowel disease) and BL-1021 (neuropathic pain) in its pipeline.
BioLineRx presently carries a Zacks Rank #3 (Hold). Meanwhile, other companies like Actelion Ltd. (ALIOF), Anthera Pharmaceuticals, Inc. (ANTH) and Athersys, Inc. (ATHX) look better positioned. While Actelion carries a Zacks Rank #1 (Strong Buy), Anthera and Athersys carry a Zacks Rank #2 (Buy).