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BioLineRx Presents Data From Successful Phase I Trial for BL-1020,in Schizophrenia at American Psychiatric Association Conference

determine the pharmacokinetics of BL-1020, and to assess its ability to block activity of the neurotransmitter dopamine, implicated in schizophrenia.

48 volunteers participated in the Phase I trial. They were randomized and enrolled into 6 dose cohorts at a ratio of 6:2 (BL-1020: placebo). In each cohort, patients received a single dose or matching placebo (4, 8, 16, 24, 32 or 40 mg). The results demonstrate that BL-1020 was well tolerated following administration of a single dose up to 40 mg, with no adverse drug related effects on ECG parameters, clinical lab data and neurological assessments.

About BL-1020

BL-1020 is an orally available GABA enhanced antipsychotic clinical candidate for the treatment of schizophrenia. Data from preclinical and phase I studies demonstrated that the compound may retain the efficacy of currently available typical and atypical antipsychotic drugs while achieving a much higher safety profile as evidenced by a lack of metabolic or extrapyramidal side effects.

BL-1020 is designed to simultaneously target the dopamine hyperactivity and GABA hypoactivity of schizophrenia. Exogenously administered GABA is ineffective as a therapeutic agent due to its inability to cross the blood brain barrier. Pharmacokinetic studies demonstrate that BL-1020 provides effective transport of GABA into the brain, overcoming this challenge. Receptor binding studies indicate that BL-1020 has a high affinity to dopamine and specific GABA-A agonist activity. This unique clinical profile may explain the reduction in side effects observed in animals and may contribute to improving cognitive function in schizophrenia.

BL-1020 is being developed by BioLineRx, Ltd. under a worldwide exclusive license from Ramot at Tel Aviv University Ltd. and Bar-Ilan Research and Development Company Ltd., the technology transfer arms of Tel Aviv University and Bar-Ilan University respectively. BL-1020 was discovered by Professor Abraham Nudelman fro
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