BioLineRx has announced that it intends to conduct an 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.
The interim analysis, which is expected to be finalized in the first quarter of 2013, 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.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, “The recent re-analysis of BL-1020's EAGLE Phase IIb study, showing a substantially greater beneficial effect of the drug on cognitive function in schizophrenia patients, as compared to the original analysis of the study, has increased our confidence in the potential of this first-in-class drug candidate. This, together with other positive ad-hoc analyses, as well as BL-1020's excellent track record in both clinical and pre-clinical studies, has prompted us to initiate an interim analysis of the on-going CLARITY Phase II/III trial. Assuming the recruitment rate continues as planned, we expect to conduct a meaningful interim analysis of the short-term cognitive effects of BL-1020 on schizophrenic patients in the first quarter of next year. We hope that the results will reinforce our confidence regarding the cognitive benefits of the drug, and if so, will enable us to expedite our commercialization efforts for the further development of this promising therapeutic candidate. We are eagerly looking forward to the results of the interim analysis."
Earlier this month, the Company has announced that a recent re-analysis of the results of the Phase IIb EAGLE clinical trial of BL-1020 showed that, when taking into account effects of the circadian rhythm (i.e., 24-hour time cycle) on cognitive function of the subjects, BL-1020 is even more potent in improving cognitive function than initially thought.
The ramifications of this re-analysis have been taken into account in the execution of the CLARITY trial.