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GEN News Highlights : Jun 27, 2011

BioLineRx Licenses Phase II-Ready IBD Drug from Hebrew University

Drug already evaluated against myasthenia gravis will be developed for inflammatory diseases as well.

BioLineRx negotiated an exclusive license to develop an orally available, Phase II-ready inflammatory bowel disease candidate, BL-7040, originating from research at the Hebrew University of Jerusalem. The worldwide licensing deal has been signed with Yissum Research Development, the technology transfer arm of the Hebrew University.

BL-7040 has dual activity at the nervous and immune systems, which Yissum claims means the candidate could have applications in the treatment of both neurological diseases and immune system-related conditions including inflammatory or autoimmune diseases. BL-7040 has already been successfully tested in Phase Ib and IIa trials against myasthenia gravis, but the discovery of a new mechanism of action for the drug has prompted BioLineRx to reposition the drug to the wider markets of IBD and other inflammatory diseases.

BL-7040 acts to suppress inflammatory responses by directly activating the anti-inflammatory protein TLR-9 and increasing activity of the cholinergic, anti-inflammatory pathway, states the drug’s original inventor, Professor Hermona Soreq from Hebrew University.

BioLineRx says addition of BL-7040 to its pipeline means the firm now has five candidates in clinical development. BL-1020 is a GABA-enhanced antipsychotic that combines dopamine antagonism with GABAergic activity, which is poised to start in a Phase II/III trial against schizophrenia. BL-1040 will shortly start in two pivotal trials for the treatment of patients following myocardial infarction, and has been licensed out to Ikaria for development and commercialization.

BL-5010 is a topical formulation of already approved components, which is in development for the non-surgical removal of benign skin lesions such as seborrheic keratosis. A Phase I/II trial evaluating BL-5010 in seborrheic keratosis has been completed in Germany and the Netherlands. BL-1021 is an orally available NCE designed to inhibit the reuptake of norepinephrine and serotonin. The drug is undergoing Phase I evaluation as a potential treatment for neuropathic pain.