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news.BioLineRx has announced positive interim results from an ongoing Phase II trial of an orally available GABA enhanced antipsychotic clinical candidate for the treatment of schizophrenia.
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The study is an open-label, multi-center, six-week trial conducted in hospitalized patients with treatment resistant schizophrenia, in which BL-1020 showed statistically significant efficacy with minimal side effects. The assessment was part of a planned review by an independent safety monitoring board (ISMB) that reviewed the first 20 schizophrenic patients that completed 21 days of the study.
Preliminary evidence of efficacy was obtained from the analysis of the positive and negative syndrome scale (PANSS) and clinical global impression (CGI) scores that are widely recognized measures of the severity of schizophrenia.
Analyses showed that BL-1020 treatment reduces the PANSS total score by 26.1 points from the baseline (p<0.001) (baseline=85.6, day 42=58.2). There was a significant (p<0.001) improvement in PANSS negative score by 7.1 points when compared to baseline values (baseline=20.5, day 42=13.4). Furthermore, CGI results showed that 92.35% of patients improved by at least one category by the end of this part of the study. Based on the data, the ISMB unanimously recommended continuation of the study as designed.