BioLineRx has announced that the results of the interim analysis of the Phase II/III CLARITY trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, are expected during the week beginning March 18, 2013.
The interim analysis will be performed on data of approximately 235 randomized patients from 27 sites in Romania and India.
The primary endpoint of the analysis will be the six-week effect of the drug on cognitive function, which is a principal deficit in schizophrenia patients.
The interim analysis will be performed by a fully independent, external Data Monitoring Committee (DMC), which will maintain complete blinding of all study data from the Company.
As a result of the analysis, the DMC will provide the Company with an estimate of the total number of patients required in the study in order to achieve statistical significance on the cognitive endpoints of the study.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, “We are very excited with the excellent development pace and huge potential of our lead product, BL-1020 for the treatment of schizophrenia. Current schizophrenia drugs are ineffective at improving the cognitive deficit associated with the vast majority of schizophrenia patients. In our previous Phase IIb EAGLE study on 363 patients, BL-1020 demonstrated a significant effect on cognitive function in schizophrenia patients as an exploratory endpoint. The current CLARITY trial is specifically designed and powered with cognition improvement as its primary endpoint, using the MCCB testing battery - the most widely recognized battery for cognition. In addition, the current trial also assesses both the short-term and long-term effects of the drug on cognition.
"BL-1020's interim analysis is an important milestone for BioLineRx; one which we believe will greatly enhance the commercialization prospects and market value of this promising drug. We are already seeing significantly enhanced interest by potential partners, as evidenced by the numerous meetings we have this week at the JP Morgan Conference in San Francisco. We eagerly await the results of the study, which mark an important landmark in the development of our lead product and the Company as a whole," concluded Dr. Savitsky.
In October, 2012, the Company announced its intention to conduct an interim analysis of the on-going Phase II/III CLARITY trial of BL-1020.
The decision followed a re-analysis of BL-1020's Phase IIb EAGLE study, showing a substantially greater beneficial effect of the drug on cognitive function in schizophrenia patients when compared to the original analysis of the study, in addition to other positive ad-hoc analyses and BL-1020's excellent track record in both clinical and pre-clinical studies.