BioLineRx 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.
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