Date: 2013-03-20
Type of information: Interim results
phase: 2-3
Announcement: results from interim analysis
Company: BiolineRx (Israel)
Product: BL-1020
Action
mechanism: BL-1020 is a novel, first in class, oral therapeutic for schizophrenia. Pre-clinical and clinical trials to date have shown that BL-1020 is effective at treating schizophrenia symptoms and has a good safety profile. These trials have shown that BL-1020 blocks activity of the neurotransmitter dopamine and enhances the activity of another neurotransmitter, GABA. These characteristics may contribute to the efficacy and safety of the drug. In addition, clinical trials have shown that BL-1020 improves cognitive function in schizophrenia patients. Many schizophrenia patients suffer from a significant decrease in cognitive function, which is an unmet medical need not addressed by current therapies.
Disease: schizophrenia
Therapeutic area: Mental diseases
Country: India, Romania
Trial
details: The CLARITY trial is a randomized, double-blinded, positive-controlled study that will enroll up to 450 patients experiencing an acute exacerbation of schizophrenia. The study will be conducted in India and in Romania. The goal of the study is to determine the short-term and long-term cognitive efficacy as well as the anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia patients, over periods of six, 12 and 24 weeks. Risperidone, an approved and widely used schizophrenia drug, serves as the positive control for antipsychotic efficacy. The cognition primary endpoint measure will utilize the MATRICS Cognitive Consensus Battery (MCCB), and cognitive benefit will be assessed by comparing the change from baseline in total MCCB score, comparing BL-1020 to Risperidone at the landmarks of six, 12 and 24 weeks. The original protocols for the study included a placebo arm for the first six weeks of the study; however, this arm was removed from the protocols at the request of the regulatory authorities.
Latest
news: * On March 20, 2013, BioLineRx, a biopharmaceutical development company, has announced that results from a pre-planned interim analysis of the Phase II/III CLARITY trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, indicate that the trial would not meet the pre-specified primary efficacy endpoint. The interim analysis included data on 230 subjects, of which 168 were evaluable for analysis on the primary (six-week) cognitive endpoint. The analysis indicated no efficacy of BL-1020, in comparison to Risperidone, relative to the cognitive primary and secondary (12-week and 24-week) endpoints. However, in several statistical parameters specified in the statistical analysis plan (SAP), positive trends in cognition were observed. The Company intends to perform a complete analysis of the un-blinded study data on all patients enrolled to date in order to ascertain whether there may be future potential for the product. After conferring with the study’s independent Data Monitoring Committee (DMC), the Company has decided to discontinue the CLARITY study. No additional patients will be enrolled in the trial. As a result of the CLARITY study termination, BioLineRx anticipates that planned research and development expenses will decrease for the remainder of 2013 and part of 2014 by approximately $6 to $7 million, thus allowing the Company’s current cash reserves of approximately $28 million to fund its expected operations into 2015.
* On November 22, 2011, BioLineRx has announced that it has received approval from the Indian regulatory authorities and the Indian local ethics committees to commence the Phase II/III CLARITY clinical trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia. The Initiation Visits at the first few Indian clinical research centers will be completed in November, with enrollment of the first patient expected in December. Additional centers in India will also be joining the trial over the coming weeks. Overall, the trial is expected to be conducted at approximately 18 sites in India, 14 sites in Romania and four sites in Israel.
The company has announced that top-line results from the CLARITY trial are expected in early 2013.
* On June 28, 2011, BioLineRx has announced the enrollment of the first patient in the Phase II/III CLARITY clinical trial of BL-1020.
