BioLineRx BLRX BLRX, a biopharmaceutical development company, announced today that the results of the 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, are expected during the week beginning March 18, 2013. The interim analysis will be performed on data of approximately 235 randomized patients from 27 sites in Romania and India. The primary endpoint of the analysis will be the six-week effect of the drug on cognitive function, which is a principal deficit in schizophrenia patients.
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.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, “We are very excited with the excellent development pace and huge potential of our lead product, BL-1020 for the treatment of schizophrenia. Current schizophrenia drugs are ineffective at improving the cognitive deficit associated with the vast majority of schizophrenia patients. In our previous Phase IIb EAGLE study on 363 patients, BL-1020 demonstrated a significant effect on cognitive function in schizophrenia patients as an exploratory endpoint. The current CLARITY trial is specifically designed and powered with cognition improvement as its primary endpoint, using the MCCB testing battery - the most widely recognized battery for cognition. In addition, the current trial also assesses both the short-term and long-term effects of the drug on cognition.
"BL-1020's interim analysis is an important milestone for BioLineRx; one which we believe will greatly enhance the commercialization prospects and market value of this promising drug. We are already seeing significantly enhanced interest by potential partners, as evidenced by the numerous meetings we have this week at the JP Morgan Conference in San Francisco. We eagerly await the results of the study, which mark an important landmark in the development of our lead product and the Company as a whole," concluded Dr. Savitsky.
In October, 2012, the Company announced its intention to conduct an interim analysis of the on-going Phase II/III CLARITY trial of BL-1020. The decision followed a re-analysis of BL-1020's Phase IIb EAGLE study, showing a substantially greater beneficial effect of the drug on cognitive function in schizophrenia patients when compared to the original analysis of the study, in addition to other positive ad-hoc analyses and BL-1020's excellent track record in both clinical and pre-clinical studies.
BL-1020 is a first-in-class GABA-enhanced antipsychotic that combines dopamine antagonism with GABAergic activity. BL-1020 has demonstrated high efficacy and safety with minimal EPS and no metabolic side effects. Most importantly, BL-1020 may have the potential to improve cognition, which is a significant unmet medical need in schizophrenia and other neurological/psychiatric disorders. Three clinical studies have confirmed the safety and efficacy of BL-1020, while pre-clinical studies have also shown that BL-1020's GABA enhancement may provide the basis for improved cognition.
In June 2011, BioLineRx commenced the Phase II/III CLARITY clinical trial of BL-1020. This 450-patient trial aims to determine the short-term (6 weeks) and the long-term (24 weeks) cognitive benefit and anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia patients, compared with Risperidone (one of the leading schizophrenia treatments). The CLARITY trial is proceeding at approximately 30 sites in Romania and India.
Schizophrenia is a serious mental disorder that affects about 1% of the world's population. It is a multi-factorial disease characterized by delusions and hallucinations, emotional withdrawal and apathy, poor attention and disorganization. The worldwide antipsychotic therapeutic market in 2011 was estimated at approximately $20 billion.
BioLineRx is a publicly-traded biopharmaceutical development company. BioLineRx is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx's current portfolio consists of six clinical stage candidates: BL-1020 for schizophrenia is currently undergoing a Phase II/III study; BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Ikaria Inc., is currently undergoing a pivotal CE-Mark registration trial; BL-5010 for non-surgical removal of skin lesions has completed a Phase I/II study; BL-1021 for neuropathic pain is in Phase I development, BL-7040 for treating inflammatory bowel disease (IBD) is currently undergoing a Phase II trial, and BL-8040 for treating acute myeloid leukemia (AML) and other hematological cancers has completed Phase I. In addition, BioLineRx has eight products in various pre-clinical development stages for a variety of indications, including central nervous system diseases, infectious diseases, cardiovascular and autoimmune diseases.
BioLineRx's business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government's Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization. For more information on BioLineRx, please visit www.biolinerx.com.
Various statements in this release concerning BioLineRx's future expectations, including specifically those related to the development and commercialization of BL-1020, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as “may”, “expects”, “anticipates”, “believes”, and “intends”, and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the “Risk Factors” section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2012. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
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