BL-1020 is a first in class GABA enhanced antipsychotic that combines dopamine antagonism with GABAergic activity. BL-1020 has demonstrated high efficacy and safety with minimal EPS and no metabolic side effects. Most importantly, BL-1020 has now been shown to clinically improve cognition, which is a significant unmet medical need in schizophrenia and other neurological/psychiatric disorders. Three other clinical studies have confirmed the safety and efficacy of BL-1020 while pre-clinical studies have also shown that BL-1020’s GABA enhancement may provide the basis for the improved cognition seen in the clinic.
BioLineRx has obtained a worldwide exclusive license for BL-1020 from Bar-Ilan Research and Development Company Ltd. and Ramot at Tel Aviv University Ltd. BL-1020 was invented by Prof. Abraham Nudelman (Department of Chemistry, Bar-Ilan University), Dr. Ada Rephaeli, Prof. Abraham Weizman and Dr. Irit Gil-Ad (Faculty of Medicine, Tel-Aviv University).
The EAGLE study was conducted under a U.S. Food and Drug Administration Investigational New Drug (IND) at approximately 40 sites in the U.S., Europe and India and included patients suffering from acute exacerbation of schizophrenia. In this six-week study, 363 patients were randomized equally to treatment with low (10 mg/day) or high (20-30mg/day) dose of BL-1020, Risperidone (2-8mg/day) or placebo. The study was designed to demonstrate statistically significant superiority of BL-1020 to placebo on the primary efficacy measure, the total score of the Positive and Negative Symptom Scale (PANSS). Key secondary efficacy measures included the Clinical Global Impression of Severity (CGI-S), the Clinical Global Impression of Change (CGI-C) from baseline, and effect on cognition as measured by the Brief Assessment of Cognition in Schizophrenia (BACS). Risperidone at a dose of 2-8 mg was included as a positive control to validate the study results.
BioLineRx, a clinical stage drug development company traded on the Tel Aviv Stock Exchange (TASE: BLRX), is dedicated to building a robust pipeline of promising therapeutics for unmet medical needs. The Company’s leading programs are BL-1020 for the treatment of schizophrenia and BL-1040 for treatment of damaged heart tissue following acute myocardial infarction. BL-1040 has recently been out-licensed to Ikaria for a total deal value of $282.5 million. Additional products under development include clinical and pre-clinical compounds for various indications. For more information, please visit www.biolinerx.com.
About NeuroCog Trials
NeuroCog Trials, Inc. is a cognition services company devoted to applying academic-quality standards to training, certification, and data quality assurance for neurocognitive outcomes in multi-site clinical trials. The company has overseen the neurocognitive assessment procedures for over 50 national and international multi-site clinical trials working with a variety of pharmaceutical companies and academic consortia. NeuroCog Trials has certified over 2000 neurocognitive testers and assured data quality for over 30,000 assessments using various assessment tools, including the Brief Assessment of Cognition in Schizophrenia (BACS), MATRICS Consensus Cognitive Battery (MCCB), Brief Assessment of Cognition in Affective Disorders (BAC-A), Brief Assessment of Cognition (BAC), the UCSD Performance-based Skills Assessments (UPSA, UPSA-B) and Schizophrenia Cognition Rating Scale (SCoRS). NeuroCog Trials has the exclusive rights to license the BACS and related instruments, the SCoRS, and all UPSA versions. Please visit www.neurocogtrials.com.