BioLineRx has announced the publication of results from the Phase II EAGLE clinical trial for BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, showing that BL-1020 is safe and effective in improving schizophrenia, in addition to improving cognitive impairment associated with this condition.
The findings, which were originally announced in September 2009, were published in the September 2012 issue of the Journal of Clinical Psychiatry.
"Significant cognitive impairment is very common in schizophrenia, affecting the great majority of patients, yet currently available antipsychotics have not been effective in treating core cognitive impairment for people suffering from this disease. In fact, two recent landmark studies, in first-episode patients and in chronically ill patients, did not find first- or second-generation antipsychotics to be significantly effective in ameliorating cognitive impairment," explained Richard Keefe, Ph.D., Professor of Psychiatry and Behavioral Sciences and Psychology at Duke University Medical Center, and co-author of the Paper.
Keefe continued, "Cognitive impairments are important targets for intervention, as they affect vocational and social functioning and independent living. Therefore, there is a clear need for new antipsychotic drugs that are effective and that improve cognition. In the Phase IIb EAGLE study, BL-1020 shows a clear and significant effect in improving cognitive function in schizophrenia patients."
The Paper describes the results of the Phase IIb EAGLE study for determining safety, efficacy, and tolerability of low (10 mg/d) and flexible high (20-30 mg/d) doses of BL-1020 compared to Risperidone, an approved atypical schizophrenia drug, and placebo.
Results of the study shows that BL-1020 was significantly better than the placebo and comparable with Risperidone in both PANSS and CGI scores, which are widely recognized measures of severity and improvement in schizophrenia.
More importantly, the results show a significant improvement in cognitive function as assessed by BACS (Brief Assessment of Cognition in Schizophrenia), when compared to both placebo and Risperidone.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, "We are pleased with the publication of the EAGLE trial results in a leading scientific journal. Nearly 1% of the world’s population suffers from schizophrenia, which often involves cognitive impairment that may severely undermine daily living skills. Current schizophrenia therapies do not address cognitive impairment, whereas the EAGLE clinical trial shows that BL-1020 significantly enhances cognitive function in schizophrenia patients and therefore has the potential to enhance the functionality and independent living skills of patients with schizophrenia. In order to further validate these results, we are currently conducting the CLARITY clinical trial, which assesses cognition enhancement by BL-1020 as its primary objective. We look forward to the expected results in the second half of 2013.”