BioLineRx Announces Publication of EAGLE Study Results Demonstrating BL-1020's Efficacy in Improving Cognitive Function in Schizophrenia Patients
– Results of Phase IIb clinical trial from
– BL-1020 is currently undergoing Phase II/III CLARITY clinical trial with results expected in H2 2013 –
"Significant cognitive impairment is very common in schizophrenia,
affecting the great majority of patients, yet currently available
antipsychotics have not been effective in treating core cognitive
impairment for people suffering from this disease. In fact, two recent
landmark studies, in first-episode patients and in chronically ill
patients, did not find first- or second-generation antipsychotics to be
significantly effective in ameliorating cognitive impairment," explained
The Paper describes the results of the Phase IIb EAGLE study for determining safety, efficacy, and tolerability of low (10 mg/d) and flexible high (20–30 mg/d) doses of BL-1020 compared to Risperidone, an approved atypical schizophrenia drug, and placebo. Results of the study shows that BL-1020 was significantly better than the placebo and comparable with Risperidone in both PANSS and CGI scores, which are widely recognized measures of severity and improvement in schizophrenia. More importantly, the results show a significant improvement in cognitive function as assessed by BACS (Brief Assessment of Cognition in Schizophrenia), when compared to both placebo and Risperidone.
Dr.
About BL-1020
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
About Schizophrenia
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
About BioLineRx
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
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
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
Source: BioLineRx
KCSA Strategic Communications
Garth Russell / Todd Fromer
1
212-896-1250 / 1 212-896-1215
grussell@kcsa.com
/ tfromer@kcsa.com
or
BioLineRx
Tsipi
Haitovsky
Public Relations
+972-52-598-9892
tsipih@netvision.net.il