BioLineRx (NASDAQ:BLRX) (TASE:BLRX) 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 GABA-enhanced antipsychotic for the treatment of schizophrenia. In June 2011, BioLineRx announced the commencement of patient enrollment in the CLARITY trial in Romania.
According to Kinneret Savitsky, CEO of BioLineRx top-line results from the CLARITY trial will be available in early 2013.
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 CLARITY trial is a randomized, double-blinded, positive-controlled study that will enroll up to 450 patients experiencing an acute exacerbation of schizophrenia. 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.