Date: 2012-10-09
Type of information: Results
phase: 2b
Announcement: results
Company: BiolineRx (Israel)
Product: BL-1020
Action
mechanism: 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 may have the potential to improve cognition, which is a significant unmet medical need in schizophrenia and other neurological/psychiatric disorders. Three 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 improved cognition.
Disease: schizophrenia
Therapeutic area: Mental diseases
Country:
Trial details:
Latest
news: * On October 9, 2012, BioLineRx, a biopharmaceutical development company, has announced that a recent analysis of the results from the Phase IIb EAGLE trial for BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, indicates that BL-1020 demonstrated a significant increase in efficacy at improving cognitive impairment associated with this condition, as compared to the original analysis of the study.
The findings pertain to the results of the Phase IIb EAGLE study, first published in September 2009, for determining safety, efficacy, and tolerability of BL-1020 compared to risperidone, an approved atypical antipsychotic drug, and placebo. Results of the study showed 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. In addition, the results showed a statistically significant improvement in cognitive function as assessed by BACS (Brief Assessment of Cognition in Schizophrenia), when compared to both placebo and risperidone.
Recently, an outside research group performed a further analysis of the results of the EAGLE study, which specifically take into account effects of the circadian rhythm (i.e., 24-hour time cycle) on cognitive function of the subjects. Results of the re-analysis clearly show that when the time of day for administration of the neurocognitive BACS test was consistent between visits, the beneficial effect of BL-1020 on cognitive function was even more pronounced than the original analysis. Specifically, the original analysis for all patients in the study showed an effect size of 0.40 for BL-1020 versus placebo and an effect size of 0.39 for BL-1020 versus Risperidone. However, according to the re-analysis, for the subset of patients with consistent testing times, the effect size increased significantly, to 0.97 for BL-1020 versus placebo and 0.57 for BL-1020 versus Risperidone. These results mean that the beneficial effect of BL-1020 on cognitive function, when compared to the original analysis, more than doubled versus placebo and increased by almost 50% versus risperidone.
* On September 27, 2012, BioLineRx has announced the publication of results from the Phase II EAGLE clinical trial for BL-1020, 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.
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.
