Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

New Analysis of EAGLE Phase IIb Study Show an Increased Efficacy of BL-1020 in Improving Cognitive Function

Published: Friday, October 12, 2012
Last Updated: Friday, October 12, 2012
Bookmark and Share
BL-1020 is currently undergoing the CLARITY Phase II/III clinical trial with results expected in H2 2013.

BioLineRx has announced that a recent analysis of the results from the Phase IIb EAGLE trial for BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, indicates that BL-1020 demonstrated a significant increase in efficacy at improving cognitive impairment associated with this condition, as compared to the original analysis of the study.

The findings pertain to the results of the Phase IIb EAGLE study, first published in September 2009, for determining safety, efficacy, and tolerability of BL-1020 compared to Risperidone, an approved atypical antipsychotic drug, and placebo.

Results of the study showed 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.

In addition, the results showed a statistically significant improvement in cognitive function as assessed by BACS (Brief Assessment of Cognition in Schizophrenia), when compared to both placebo and Risperidone.

Recently, an outside research group performed a further analysis of the results of the EAGLE study, which specifically take into account effects of the circadian rhythm (i.e., 24-hour time cycle) on cognitive function of the subjects.

Results of the re-analysis clearly show that when the time of day for administration of the neurocognitive BACS test was consistent between visits, the beneficial effect of BL-1020 on cognitive function was even more pronounced than the original analysis.

Specifically, the original analysis for all patients in the study showed an effect size of 0.40 for BL-1020 versus placebo and an effect size of 0.39 for BL-1020 versus Risperidone.

However, according to the re-analysis, for the subset of patients with consistent testing times, the effect size increased significantly, to 0.97 for BL-1020 versus placebo and 0.57 for BL-1020 versus Risperidone.

These results mean that the beneficial effect of BL-1020 on cognitive function, when compared to the original analysis, more than doubled versus placebo and increased by almost 50% versus Risperidone.

Dr. Kinneret Savitsky, CEO of BioLineRx, stated, “Cognitive functioning is influenced by circadian rhythms over the course of the day, and patients with schizophrenia are known to have profoundly disturbed circadian rhythms that can affect their cognitive functioning. Therefore, a new analysis was performed to determine whether taking into account consistency in the timing of neurocognitive testing between the baseline and endpoint visits could affect assessment of the efficacy of BL-1020. This analysis found that when the baseline and endpoint visits were conducted at the same time of day, there was a significantly more robust treatment response as compared to those patients where the timing of the visits was inconsistent. These findings indicate that BL-1020 is even more efficient at improving cognitive function than was previously shown.”

"We are very excited with these new findings by an outside group of leading scientists relating to the EAGLE trial. The results not only show an increased efficacy of BL-1020 in improving cognitive function in schizophrenia patients, but also have positive implications on conducting and analyzing the ongoing CLARITY trial, which is specifically designed for assessing BL-1020’s cognition enhancement effect," concluded Dr. Savitsky.

Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More Than 5,200+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

BioLineRx Announces Initiation of Phase 2 Trial
Company has announced the initiation of a Phase 2 trial for BL-8040 as novel stem cell mobilization treatment.
Saturday, March 26, 2016
BioLineRx Announces Collaboration with MSD
Collaboration to investigate the combination of KEYTRUDA (pembrolizumab) and BL-8040 in pancreatic cancer.
Wednesday, January 13, 2016
BioLineRx Announces Regulatory Submission for Phase 2 Trial of BL-8040
Study will be conducted in collaboration with Washington University School of Medicine, Division of Hematology and Oncology.
Thursday, December 17, 2015
BioLineRx Announces Initiation of Phase 1/2 Trial for BL-8040
Interim results of study, in patients with hypoplastic myelodysplastic syndrome (hMDS) and aplastic anemia (AA), expected by end of 2016.
Thursday, November 26, 2015
BioLineRx Announces Positive Results from First Part of Phase 2 Trial in r/r AML
Data strongly suggest BL-8040 has potent anti-leukemic activity in combination with Ara-C in AML.
Saturday, November 07, 2015
BioLineRx’s BL-5010 Submitted for CE Mark Registration
Product expected to reach the market in 2016.
Friday, September 11, 2015
BioLineRx Announces Regulatory Submission for Phase 2 Trial of BL-8040
Study collaboration with MD Anderson Cancer Center will assess BL-8040 as combination treatment with immunosuppressants.
Friday, September 11, 2015
BioLineRx Reports Second Quarter 2015 Financial Results
Company to initiate a pivotal CE Mark registration study for BL-7010 in the fourth quarter of 2015.
Saturday, August 22, 2015
BioLineRx Announces Initiation of Phase 2b Trial for Novel AML Consolidation Treatment
Study is first of three additional clinical studies for BL-8040 platform expected to commence during 2015.
Tuesday, August 18, 2015
Top-Line Results from Bellerophon’s PRESERVATION I Clinical Trial for BCM
An investigational, implantable medical device being studied for the prevention of heart failure following an AMI.
Wednesday, August 05, 2015
BioLineRx to Present Successful Results of Phase 1/2 Study for BL-7010
Company will present results at the 16th International Celiac Disease Symposium (ICDS 2015).
Friday, June 19, 2015
BioLineRx Presents Positive Safety and Efficacy Results for BL-8040
BL-8040’s rapid stem-cell mobilization supports stand-alone one-day treatment for stem-cell collection.
Tuesday, June 16, 2015
Research Underlying BL-9020 Wins Hebrew University's Kaye Innovation Award
BL-9020, a novel monoclonal antibody for the treatment of Type 1 diabetes.
Saturday, June 13, 2015
BioLineRx Announces Publication of BL-5010 Phase 1/2 Trial Results
Previously reported results published in British Journal of Dermatology.
Thursday, June 04, 2015
BioLineRx Initiates Expansion Stage of Phase 2 Clinical Trial for AML Treatment
Top-line results expected Q4 2015.
Tuesday, May 05, 2015
Scientific News
How it Works: Advanced Data Analysis Using Visualization
Visualisation of data can be used to help molecular biologists tackle the vast datasets their experiments create.
Unravelling the Role of Key Genes and DNA Methylation in Blood Cell Malignancies
Researchers from the University of Nebraska Medical Center have demonstrated the role of Dnmt3a in safeguarding normal haematopoiesis.
Salford Lung Study - The First Real World Clinical Trial
In this podcast, we learn about the Salford Lung Study and its potential to revolutionize the way we assess new drugs and treatments around the world.
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Epigenetics and Neural Cell Death
Researchers demonstrate how deregulation of an epigenetic mechanism active in early neurogenesis phases triggers neural cell death.
Ebola-Affected Countries Receive NIH Support
The National Institutes of Health has established a new program to further research capacity to study Ebola and other epidemics.
Immunotherapy Technique Holds Promise for Curing Food Allergies
Scientists develop immunotherapy technique that almost eliminating allergic response and anaphylactic response in food-allergic mice.
Skin Patch to Treat Peanut Allergy
NIH-funded study suggests peanut protein patch is a safe and convenient method of treatment.
Molecular Origins of Dust Mite Allergy Discovered
Scientists have identified molecules of house dust mites that are targeted by the immune system of children, developing allergic rhinitis and asthma.
Scientists Uncover Why Hepatitis C Vaccine is Difficult to Make
Scientists have uncovered one reason why a successful hepatitis C vaccine continues to be elusive.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,200+ scientific videos