BioLineRx, Ltd. announced the results of the interim analysis of the Phase II/III CLARITY trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, are expected during the week beginning March 18, 2013. The interim analysis will be performed on data of approximately 235 randomized patients from 27 sites in Romania and India. The primary endpoint of the analysis will be the six-week effect of the drug on cognitive function, which is a principal deficit in schizophrenia patients.

The interim analysis will be performed by a fully independent, external Data Monitoring Committee (DMC), which will maintain complete blinding of all study data from the company. As a result of the analysis, the DMC will provide the company with an estimate of the total number of patients required in the study in order to achieve statistical significance on the cognitive endpoints of the study. In October, 2012, the company announced its intention to conduct an interim analysis of the on-going Phase II/III CLARITY trial of BL-1020.

The decision followed a re-analysis of BL-1020's Phase IIb EAGLE study, showing a substantially greater beneficial effect of the drug on cognitive function in schizophrenia patients when compared to the original analysis of the study, in addition to other positive ad-hoc analyses and BL-1020's excellent track record in both clinical and pre-clinical studies.