BioLineRx (TASE:BLRX), a biopharmaceutical development company, announced today the enrollment of the first patient in the Phase II/III CLARITY clinical trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia.
The CLARITY trial is designed as a randomized, double-blind, placebo-controlled study and is expected to be conducted in 15 sites in Romania and 19 sites in India, on a total of 435 patients experiencing an acute exacerbation of schizophrenia. The primary endpoints of the study are to determine the short-term cognitive benefit and anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia patients, over a period of 6 weeks, compared with Risperidone, an approved atypical schizophrenia drug, and placebo. Determination of the long term effects of the drug, over a period of 24 weeks, is a secondary endpoint.
"It is generally accepted that the most important domains of neurocognitive functioning that are impaired in people with schizophrenia are working memory, attention, verbal and visual learning, reasoning and social cognition. There is a clear need for new antipsychotic drugs that are effective and improve cognition," commented Richard Keefe, Ph.D., Professor of Psychiatry and Behavioral Sciences and Psychology at Duke University Medical Center. "Results of clinical and nonclinical trials to date suggest that BL-1020 has the potential to be an efficacious anti-schizophrenic drug while also improving cognition."
"The initiation of the CLARITY trial represents a very positive and important step towards the commercialization of BL-1020. We expect to report results from the trial in the fourth quarter of 2012, and if this trial is successful, it will further demonstrate BL-1020's unique properties of improving both schizophrenia symptoms and cognition," stated Dr. Kinneret Savitsky, BioLineRx's CEO. "Currently, there is no schizophrenia treatment available that also improves cognition, so this represents an important unmet medical need for patients suffering from this disorder. We believe that BL-1020, with its unique properties, especially improvement of cognitive function, will become a significant advance in the treatment of people suffering from schizophrenia."