BioLineRx Ltd. (TASE:BLRX), a clinical stage drug development company, announced positive results from a Phase 2a trial of BL-1020, a GABA-enhanced antipsychotic. BL-1020 showed statistically significant efficacy with no significant change in weight and no increase in extrapyramidal symptoms at study completion. The Company had announced positive interim results from the trial in October 2007.
The trial was an open label, 6-week study conducted under Good Clinical Practices guidelines designed to determine the safety and maximum tolerated dose of BL-1020 in schizophrenic patients. The study was conducted on 36 treatment refractory hospitalized patients of whom only 3 withdrew early from the study. Patients were started on 32mg (20mg free base) of BL-1020 and received increasing dosages over the first 7 days in order to reach the maximum dose of 64 mg (40mg free base). Significant improvement was seen already after 7 days of treatment.
The results of the study were as follows:
- Patients being treated with BL-1020 experienced a statistically significant improvement from baseline in the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression of Severity and Improvement (CGI-S; CGI-I), which are widely recognized measures of severity and improvement in schizophrenia. There was a statistically significant (p<0.001) improvement on the PANSS total (baseline=84.9; day 42=63.8), and the positive (baseline=22.3; day 42=15.1) negative (baseline=20.9; day 42=16.6) and general psychopathology subscales (baseline=42.4; day 42=32.1). More than 80% of the patients showed a clinically significant improvement as reflected by the CGI-S and CGI-I.
- No severe or unexpected adverse effects occurred in the trial. There was no significant increase in extrapyramidal symptoms at the end of the trial, and no significant change in weight. No notable findings on ECG, laboratory values or vital signs. All adverse events were characterized as minimal and not treatment limiting. Most common adverse effects were insomnia, sleepiness, agitation, akathisia, nausea, increased prolactin anxiety and diarrhea.
- Only 3 patients out of 36 withdrew from the trial, reflecting a low level of patient withdrawal in comparison with other drugs for the treatment of schizophrenia. Such high compliance is indicative of the efficacy and tolerability of BL-1020.
"There is a clear need for new antipsychotic drugs that combine efficacy with better tolerability. The current available drugs while effective, have patient compliance issues related to the drugs' side effects such as Parkinson-like symptoms and considerable weight gain," said Professor Michael Davidson, Director Department of Psychiatry, Sheba Medical Center. "These results suggest that BL-1020 has the potential to be developed into a next generation antipsychotic which will be efficacious with minimal adverse-effects."
"We continue to be very encouraged by these compelling results for BL-1020, and believe that it could represent a significant advance in the treatment of people suffering from schizophrenia that are in need of a safe and effective therapy that carries a hope of improving their quality of life," commented Morris C. Laster, M.D., Chief Executive Officer of BioLineRx. "We very much look forward to the initiation of the Phase 2b trial of BL-1020 shortly."
BioLineRx expects to initiate a Phase 2b trial during the second quarter of 2008, which is expected to assess the efficacy, safety and tolerability of BL-1020 as compared to placebo and Risperidone, an approved atypical schizophrenia drug. The Phase 2b study is designed as a six-week, randomized, double-blind, active and placebo-controlled, parallel group study with a blinded continuation phase in which patients who chose to continue are expected to receive active drugs. The study is expected to be conducted on 360 schizophrenia patients in 40 sites in the U.S., Europe, India and Israel.
In preparation for the Phase 2b trial, BioLineRx held an international investigators meeting in Singapore, on January 18-20. More than 170 psychiatric physicians and other clinical staff from a total of 40 sites in U.S., Europe, India and Israel participated in the meeting.
About Current Antipsychotics
There are two classes of currently available antipsychotic drugs: "typical" or "classic", representing an older generation of treatment; and "atypical" or the newer generation of currently available treatment. Both classes of drugs have side effects that result in low patient compliance. These side effects are generally but not exclusively class related. Typical antipsychotics are known to cause EPS side effects while atypical antipsychotics are known for their metabolic side effects including considerable weight gain, type 2 diabetes and dyslipidemia. As was recently demonstrated in the CATIE study conducted by the National Institute of Mental Health (NIMH), there is a significant unmet medical need for novel antipsychotic without compliance limiting side effects.
About BL-1020
BL-1020 is an orally available GABA-enhanced antipsychotic clinical candidate for the treatment of schizophrenia. In pre-clinical and three clinical trials to date, BL-1020 has consistently delivered efficacy without compliance limiting metabolic or motor side effects. These studies have shown that the compound has high dopamine blocking potency while activating GABA receptors in the brain. These properties may contribute to the safety profile of the drug by limiting EPS side effects. Moreover, based on pre-clinical data, BL-1020 can improve cognition.
BL-1020 is being developed by BioLineRx, Ltd. under a worldwide exclusive license from Ramot at Tel Aviv University Ltd. and Bar-Ilan Research and Development Company Ltd., the technology transfer arms of Tel Aviv University and Bar-Ilan University respectively. BL-1020 was discovered by Professor Abraham Nudelman from the Department of Chemistry, Bar-Ilan University; and Ada Rephaeli, Ph.D., Professor Abraham Weizman, MD, and Irit Gil-Ad, Ph.D. from the Sackler Faculty of Medicine, Tel Aviv University.
About Schizophrenia
Schizophrenia is a serious mental disorder that affects approximately 1% of the world's population. It is a multifactorial disease characterized by delusions and hallucinations, emotional withdrawal and apathy, poor attention and disorganized thoughts. Schizophrenia is the most common severe mental illness. Twenty four million people suffer from schizophrenia worldwide.
About BioLineRx
BioLineRx, a clinical stage drug development company traded on the Tel Aviv Stock Exchange (TASE:BLRX), is dedicated to building a robust pipeline of promising therapeutics for unmet medical needs. The Company's leading programs are BL-1020, just completed Phase 2a and awaiting Phase 2b, for the treatment of schizophrenia, and BL-1040, which is about to initiate clinical trials, for the treatment of damaged heart tissue post-myocardial infarction. Additional products under development include compounds for the treatment of cancer and CNS, cardiovascular, metabolic, infectious and autoimmune diseases.
BioLineRx advances projects from early stage discovery and lead generation to advanced clinical trials. BioLineRx partners with researchers, universities and biotech companies to further the development of promising compounds. The Company was founded in 2003 by leaders in the Israeli life science arena including Teva Pharmaceuticals Ltd., venture capital firms Giza Venture Capital and Pitango Venture Capital, and Hadasit, the technology transfer company of Hadassah Hospital and the Jerusalem Development Authority. For more information, please visit http://www.biolinerx.com.
This press release contains "forward-looking statements" that involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," "hope,", "look forward" and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. You should not put undue reliance on any forward-looking statements. Unless we are required to do so under applicable laws, we do not intend to update or revise any forward-looking statements.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment