BioLineRx's antipsychotic positive in Phase IIb trial
This article was originally published in Scrip
BioLineRx's lead drug candidate, the antipsychotic BL-1020 (GABA plus perphenazine), improved schizophrenia symptoms compared with placebo and improved cognitive function compared with a mainstay of treatment, show top-line Phase IIb trial results.
"These results indicate broad anti-psychotic efficacy and safety of BL-1020, equivalent to risperidone – the most effective and safe [second-generation antipsychotic], and the world's most prescribed antipsychotic," said Dr Ravi Anand, a schizophrenia expert and consultant for BioLineRx, in a statement.
However, Professor Robin Murray, who studies schizophrenia at the Institute of Psychiatry in London, UK, commented to Scrip that while the data were interesting they were "not enough to throw one's hat in the air". He noted that the dose of the drug in development – the typical antipsychotic perphenazine, which acts as a dopamine antagonist and has been in clinical use for schizophrenia for decades, plus GABA – may have been more optimal than that of risperidone.
data
In the trial, dubbed EAGLE, 363 patients were randomised to a low (10mg/day) or a high (20-30mg/day) dose of BL-1020, 2-8mg/day of risperidone or placebo for 6 weeks. The primary endpoint was superiority of the drug to placebo in the change of the Positive and Negative Symptom Scale (PANSS), a 30-point tool to assess schizophrenia symptoms. The high dose of the drug achieved statistical benefit over placebo, improving the score by 23.6 points, compared with 14.4 points (p=0.002). The Israel-based company did not disclose the effect of risperidone on the PANSS score.
As a secondary endpoint, the group assessed the effects of treatment on the Brief Assessment of Cognition in Schizophrenia (BACS) test. Whereas the scores of BL-1020-treated patients improved by 9.27 points, those of risperidone-treated patients improved by 6.2 points and those of placebo-treated patients improved by 6.01 points (p=0.027 for both).
"The amount of improvement with BL-1020 compared to the other treatments was large enough to be not only statistically significant, but clinically significant as well," said Dr Richard Keefe, professor of psychiatry and behavioural sciences at Duke University and consultant to BioLineRx.
The drug also had a promising safety profile. Incidence of severe adverse events was 0% for the high-dose of the drug, compared with 3.3% for risperidone and 6.5% for placebo, for instance. And discontinuations due to adverse events were similar 4.3% for patients on the high dose of BL-1020 or placebo, compared with 8.8% for those on risperidone.
Full study results will be presented at an upcoming conference.
The company's only other product in clinical trials is BL-1040, an alginate polymer drug that is currently in a Phase I/II development as a medical device for use in acute myocardial infarction.