Date: 2011-12-06
Type of information: Results
phase: 1a
Announcement: results
Company: BiolineRx (Israel)
Product: BL-1021
Action
mechanism: BL-1021 is an orally available small molecule for the treatment of neuropathic pain that was designed to have similar activities to other anti-neuropathic drugs without their common adverse effects. BL-1021’s efficacy has been demonstrated in various animal models of neuropathic pain. Pre-clinical data demonstrate that BL-1021 has a lowered propensity for sedation, low cardiac toxicity and improved efficacy compared with other anti-pain medications.
Disease: neuropathic pain
Therapeutic area: CNS diseases
Country: Israel
Trial
details: 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.
Latest
news: * On December 6, 2011, BioLineRx has announced 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. The company is now evaluating the next steps for BL-1021 from both a scientific and a commercial perspective, including a possible narrowing of the indication.
* On September 13, 2011, BioLineRx has announced the last visit of the last subject and preliminary results of the Phase Ia study of BL-1021. Study results demonstrated that a single administration of BL-1021 was safe and well tolerated. In addition, preliminary modeling of the pharmacokinetic data collected in this trial predicts that a once daily administration of BL-1021 at the dose levels assessed in the trial will enable reaching effective doses in patients. Final results are expected to be announced in the fourth quarter of 2011.
* On July 5, 2011, BioLineRx has announced the enrollment of the first subject in a Phase I study of BL-1021. This study is expected to enroll up to 56 subjects.
