- Cognition impairment is primary endpoint of CLARITY phase II/III trial -
- Dr. Savitsky: "BL-1020's interim results mark an important landmark in the development of our lead product and the Company as a whole" -
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.
"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
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.
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
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
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
KCSA Strategic Communications
Garth Russell / Todd Fromer
1 212-896-1250 / 1 212-896-1215
email@example.com / firstname.lastname@example.org
Tsipi Haitovsky, Public Relations