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news.The Indian regulatory authorities and the Indian local ethics committees have granted an approval to BioLineRx to begin its Phase II/III Clarity clinical trial of BL-1020.
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BL-1020 is a oral, GABA-enhanced antipsychotic drug candidate used for the treatment of schizophrenia.
The double-blinded, randomized and positive-controlled study will enroll up to 450 patients who are experiencing an acute exacerbation of schizophrenia.
The objective of study is to assess the short-term and long-term cognitive efficacy as well as the anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia patients, over periods of six, 12 and 24 weeks.
The primary endpoint will be evaluated by comparing the change from baseline in totalMatrics Cognitive Consensus Battery (MCCB) score, comparing BL-1020 to Risperidone at the landmarks of six, 12 and 24 weeks.
BioLineRx CEO Kinneret Savitsky said the trial, if successful, will support BL-1020’s potential as an antipsychotic therapy that also improves cognition.
"We look forward to announcing results from the Clarity trial in early 2013," Savitsky said.