BioLineRx (NASDAQ:BLRX) (TASE:BLRX) announced today the final results of the Phase Ia study of BL-1021, an orally available small molecule for neuropathic pain. In this study it was demonstrated that a single administration of BL-1021 in the dose range examined was safe and well tolerated, with no significant changes noted in vital signs, ECG or laboratory safety parameters at any dose when compared either to baseline measurements or to the placebo group. In addition, BL-1021 demonstrated a favorable pharmacokinetic profile and the potential for once daily oral administration. In September 2011, BioLineRx announced positive interim results from the trial.
The trial was a double-blinded, placebo-controlled study performed at the Hadassah Clinical Research Center in Jerusalem, Israel, led by Principal Investigator Professor Yosef Caraco. The study aimed at assessing the safety, tolerability and pharmacokinetics of a single administration of BL-1021 (between 10 mg and 80 mg) in healthy male subjects.
Dr. Kinneret Savitsky, BioLineRx's CEO, stated, "This study has clearly demonstrated that BL-1021 is a safe, well-tolerated drug. We have only observed mild, transient, adverse events with similar incidence to those observed in the placebo group. We are very encouraged by these results, which indicate that BL-1021 has potential as an effective treatment for neuropathic pain with minimal side effects and requiring only once daily dosing. This could mean new hope for the millions of people around the world suffering from neuropathic pain. We are now evaluating the next steps for BL-1021 from both a scientific and a commercial perspective, including a possible narrowing of the indication."