BioLineRx Announces Positive Results From Phase 2a Interim Trial Analysis Of BL-1020 For The Treatment Of Patients With Schizophrenia
November 1, 2007 – 11:49 am | posted in SchizophreniaBioLineRx Ltd. (TASE:BLRX), today announced positive interim results from an ongoing Phase 2 trial of BL-1020, a GABA enhanced antipsychotic. The study is an open-label, multi-center, 6-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.
“These results from severely ill treatment resistant patients with psychosis are extremely encouraging, as they further substantiate existing preclinical and clinical data suggesting that BL-1020 possesses the efficacy of currently available antipsychotics but without their compliance limiting motor or metabolic side effects,” commented Morris C. Laster, MD, CEO of BioLineRx. “Based on the medical need for novel therapeutics to address the severe unmet medical need for schizophrenia, and the preliminary findings in this study, we believe that BL-1020 has the potential to be a significant advance in the treatment of patients with schizophrenia.”
Preliminary evidence of efficacy was obtained from the analysis of the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression (CGI) scores, both of which 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
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