BioLineRx 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.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, “Cognitive functioning is influenced by circadian rhythms over the course of the day, and patients with schizophrenia are known to have profoundly disturbed circadian rhythms that can affect their cognitive functioning. Therefore, a new analysis was performed to determine whether taking into account consistency in the timing of neurocognitive testing between the baseline and endpoint visits could affect assessment of the efficacy of BL-1020. This analysis found that when the baseline and endpoint visits were conducted at the same time of day, there was a significantly more robust treatment response as compared to those patients where the timing of the visits was inconsistent. These findings indicate that BL-1020 is even more efficient at improving cognitive function than was previously shown.”
"We are very excited with these new findings by an outside group of leading scientists relating to the EAGLE trial. The results not only show an increased efficacy of BL-1020 in improving cognitive function in schizophrenia patients, but also have positive implications on conducting and analyzing the ongoing CLARITY trial, which is specifically designed for assessing BL-1020’s cognition enhancement effect," concluded Dr. Savitsky.