India approves start of BioLineRx Clarity trial

BioLineRx (NASDAQ:BLRX; TASE:BLRX) has received approval from the Indian regulatory authorities and local ethics committees to commence the Phase 2/3 Clarity clinical trial of BL-1020, a first-in-class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia.

Enrollment of the first patient in India is expected in December. Overall, the trial is expected to be conducted at about 18 sites in India, 14 sites in Romania and four sites in Israel. In June 2011, BioLineRx began patient enrollment in the trial in Romania, which is currently ongoing according to schedule.

“The approval to commence the trial in India represents an important milestone in the progress of the BL-1020 Clarity trial,” CEO Dr. Kinneret Savitsky said in a statement. The company also plans in the near future to submit a regulatory package to the authorities in Israel in order to open four Israeli sites for the clinical trial.

Top-line results are expected in early 2013. “Concurrent with the progress of the trial and in accordance with our business strategy, we have renewed our efforts to seek an out-licensing partner to continue development and commercialization of BL-1020,” Dr. Savitsky added.”

The Clarity trial is a randomized, double-blinded, positive-controlled study that will enrol 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.