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Pipeline Setback at BioLineRx

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BioLineRx (BLRX) recently announced disappointing results from an interim analysis of the phase II/III CLARITY trial of BL-1020. The company’s share price was down by almost 53% on the news.

BL-1020, a first in class, orally available, GABA-enhanced antipsychotic, was being developed for the treatment of schizophrenia. The interim analysis indicated that the study will not meet its primary objectives. Based on discussions with the study’s independent Data Monitoring Committee (:DMC), BioLineRx decided to terminate the CLARITY study. The company also decided not to enrol any additional patients for the study.

Following the termination of the CLARITY study, BioLineRx now expects its research and development expenses to decrease by $6 million to $7 million for the rest of 2013 and a part of 2014.

However BioLineRx’ other pipeline candidates are progressing well. Earlier this month, the company announced that the French regulatory authorities have approved the initiation of a phase I/II trial for its oral hepatitis C virus (:HCV) infection candidate, BL-8020.

The trial will evaluate the efficacy, safety and tolerability of the candidate in HCV-infected patients, who previously failed or relapsed following treatment with the standard-of-care. BioLineRx expects to report interim results from the study by year end.

Apart from BL-8020, other candidates in BioLineRx’ pipeline include BL-1040 for preventing pathological cardiac remodeling following a myocardial infarction (pivotal CE-Mark registration trial) and BL-5010 for the non-surgical removal of skin lesions (phase I/II study complete). BioLineRx expects several clinical data read outs related to its pipeline candidates in the next 12-18 months.

BioLineRx, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Biopharma companies that currently look more attractive include UCB (UCBJF), Cytokinetics Inc. (CYTK) and Array BioPharma Inc. (ARRY). Both the stocks carry a Zacks Rank #1 (Strong Buy).

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