BioLineRx completed the enrolment of 360 schizophrenia patients for BL-1020 phase IIb trial. The company completed the recruitment phase two months ahead of schedule. BioLineRx started the phase IIb trial, aimed at evaluating the efficacy, tolerability and safety of BL-1020 in July 2008.
The 6-week double blinded, placebo controlled trial, conducted under an IND in the USA, Romania and India was aimed at proving that BL-1020 is a new generation effective antipsychotic with minimal side effects.
Patients participating in the trial were randomly assigned to four groups: two groups received BL-1020 (at two dose levels), the third group received the approved antipsychotic Risperidone and the fourth received placebo. The objective of this trial was to assess the efficacy and safety of different dose levels of BL-1020 as compared to Risperidone and placebo.
Dr. Morris Laster, BioLineRx’s CEO states that “we are happy to report we’ve completed recruiting all patients for the phase IIb study earlier than planned. This means that in 6 weeks the study will be completed and that the results will be available in a few months. We are very encouraged by the high enrolment rate. Moreover, an independent safety committee has already reviewed data from the first 50 patients. We are also very much encouraged by the low drop-out rate (schizophrenia trials usually have higher dropout rate). Dr. Laster also said: “we expect BL-1020 will greatly improve the standard of care and are looking forward to receiving the results in Q3 of 2009. We hope that the phase IIb study results will form the basis for collaboration with a big pharmaceutical company, a collaboration that will enable us to complete developing and marketing BL-1020 for the benefit of schizophrenia patients.”