BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, today announced that results from a pre-planned 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, indicate that the trial would not meet the pre-specified primary efficacy endpoint. After conferring with the study’s independent Data Monitoring Committee (DMC), the Company has decided to discontinue the CLARITY study. No additional patients will be enrolled in the trial.
“These disappointing results underscore the difficulty of treating cognition in schizophrenia, which remains an unmet medical need,” stated Kinneret Savitsky, PhD, Chief Executive Officer of BioLineRx. “We would like to thank the patients and investigators for their participation and engagement in the study. While we certainly would have preferred to see a positive outcome on this trial, the decision to perform the interim analysis, without waiting until the end of the study, provides us with the opportunity to allocate additional resources to our other projects in order to accelerate their development. This confirms the advantage of our business model, which is based on a broad pipeline with a number of compounds, at different stages of development, and for multiple indications.”
As a result of the CLARITY study termination, the Company anticipates that planned research and development expenses will decrease for the remainder of 2013 and part of 2014 by approximately $6 to $7 million, thus allowing the Company’s current cash reserves of approximately $28 million to fund its expected operations into 2015. The Company expects to meet a number of significant clinical milestones related to other pipeline assets in the next 12-18 months.
About Phase II/III CLARITY Study Interim Analysis
The interim analysis included data on 230 subjects, of which 168 were evaluable for analysis on the primary (six-week) cognitive endpoint. The analysis indicated no efficacy of BL-1020, in comparison to Risperidone, relative to the cognitive primary and secondary (12-week and 24-week) endpoints. However, in several statistical parameters specified in the statistical analysis plan (SAP), positive trends in cognition were observed. The Company intends to perform a complete analysis of the un-blinded study data on all patients enrolled to date in order to ascertain whether there may be future potential for the product.