BioLineRx Provides Clarification Regarding Interim Analysis of CLARITY Trial for BL-1020
News Feb 06, 2013
BioLineRx Ltd., notes that, as previously disclosed, results from the interim analysis of the Phase II/III CLARITY clinical trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, are expected to be reported during the week of March 18, 2013.
The CLARITY trial is a randomized, double-blind trial to examine acute (6 weeks) and long-term (24 weeks) cognitive and antipsychotic efficacy, safety and tolerability of BL-1020 on patients with acute schizophrenia.
The interim analysis will be performed on data of approximately 235 randomized patients from 27 sites in Romania and India.
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.
The Company hereby emphasizes that as the CLARITY trial is on-going and given the double-blind trial design, BioLineRx at present has no insight into the results of the interim analysis.
Any media reports or comments by those outside of the Company regarding the outcome of the interim results of the CLARITY trial are merely based on speculation.