Allon Therapeutics Inc., The Neuro Protection Company, has announced that the results of the completed phase Ib clinical trial of their product AL-108 met all of its objectives. The trial confirmed that AL-108 is safe and well tolerated in 32 healthy elderly subjects after seven days of dosing.
In addition to demonstrating the safety of AL-108 upon repeat administration, the trial provided the following pharmacokinetic information:
AL-108 shows dose-dependent drug exposure in treated individuals; a half-life consistent with daily or twice daily dosing; a pharmacokinetic profile which supports the long-term use of AL-108; and Blood concentrations, when compared to pre clinical pharmacodynamic models, would be expected to be efficacious in the ongoing phase II trials.
"These results are quite positive and validate the intranasal use for AL-108. Moreover, the pharmacokinetic profile is sufficiently robust to confirm the doses selected in the multiple phase II trials now underway," said Dr Bruce Morimoto, vice-president drug development at Allon.
AL-108 is currently being evaluated in a phase II efficacy trial as part of Allon's Alzheimer's programme. This trial is expected to complete enrolment at the end of 2007. Also, AL-108 was recently selected by the National Institute of Mental Health funded project TURNS (Treatment Unit for Research of Neurocognition in Schizophrenia) for another phase II efficacy trial evaluating it as a treatment for Schizophrenia related cognitive impairment.
Allon Therapeutics Inc. is a clinical-stage Canadian biotechnology company developing drugs that protect against neurodegenerative conditions, which impact the body's central nervous system. Allon has three phase II clinical programs in Alzheimer's disease, mild cognitive impairment associated with coronary artery bypass graft (MCI-CABG) surgery and Schizophrenia related cognitive impairment.