BioLineRx’s antipsychotic drug found effective in Phase IIa trial

Patients being treated with BL-1020 experienced a statistically significant improvement from baseline in the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression of Severity and Improvement (CGI-S; CGI-I), which are widely recognized measures of severity and improvement in schizophrenia. There was a statistically significant (p<0.001) improvement on the PANSS total (baseline=84.9; day 42=63.8), and the positive (baseline=22.3; day 42=15.1) negative (baseline=20.9; day 42=16.6) and general psychopathology subscales (baseline=42.4; day 42=32.1). More than 80% of the patients showed a clinically significant improvement as reflected by the CGI-S and CGI-I. All adverse events were characterized as minimal and not treatment limiting. There was no significant increase in extrapyramidal symptoms at the end of the trial, and no significant change in weight. No notable findings on ECG, laboratory values or vital signs. Only 3 patients out of 36 withdrew from the trial, reflecting a low level of patient withdrawal in comparison with other drugs for the treatment of schizophrenia. Such high compliance is said to be indicative of the efficacy and tolerability of BL-1020. BioLineRx expects to initiate a Phase IIb trial during the second quarter of 2008, which is expected to assess the efficacy, safety and tolerability of BL-1020 as compared to placebo and Risperidone, an approved atypical schizophrenia drug. The Phase IIb study is designed as a six-week, randomized, double-blind, active and placebo-controlled, parallel group study with a blinded continuation phase in which patients who chose to continue are expected to receive active drugs. The study is expected to be conducted on 360 schizophrenia patients in 40 sites in the US, Europe, India and Israel.