Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
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
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
BioLineRx Reports Year End 2014 Financial Results
Top-line results from Phase 2a clinical study of BL-8040 expected in the second half of 2015.
Tuesday, March 31, 2015
Scientific News
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.
Anti-Inflammatory Drugs Could Help Treat Depression
Anti-inflammatory drugs could be used to treat some cases of depression, which further implicates our immune system in mental health disorders.
NIH Contributes to Global Effort to Prevent and Manage Lung Diseases
The large scale trial will measure health benefits of clean cookstoves.
Questioning the Safety of Selenium to Combat Cancer
Research indicates the need for change in practice as selenium supplements cannot be recommended for preventing colorectal cancer.
Scientists at NIH and Emory Achieve Sustained SIV Remission in Monkeys
The finding suggest that the immune systems of these animals are controlling SIV replication in the absence of antiretroviral therapy.
Painting the Way to Tumour Imaging
Tumour paint used in emergency surgery to aid cell identification for surgeons.
Anti-Cancer Drug Uses Tumour mRNA to Identify Responders
Phase I study of novel anti-cancer drug uses tumour mRNA expression to identify patients who will respond to the drug.
Targeting Estrogen Receptor Improves Survival in Breast Cancer
Trial finds estrogen receptor degrader significantly increases progression-free survival in patients with advanced breast cancer.
Clinical Trial Finds Medicine Program Alters Blood Serum
Meditation, yoga and vegetarian diet linked to decline in plasma metabolites associated with inflammation and cardiovascular disease risk.
Alzheimer’s Linked Protein Can Be Removed From Brain Without Hindering Memory, Learning
Researchers at UTSW have found that the mice can maintain their learning and memory when virtually all ApoE is removed from the brain but kept present in the liver to filter cholesterol.
Scroll Up
Scroll Down

SELECTBIO Market Reports
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