Actinogen Limited Announces Ethical Approval of Xanamem in Phase I Trial for Alzheimer’s Disease

Ana de Barros, PhD avatar

by Ana de Barros, PhD |

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Actinogen Limited, a biotechnology company focused on the treatment of Alzheimer’s Disease and mild cognitive impairment, a transitional stage of cognitive impairment between normal aging and the more serious conditions of Alzheimer’s and dementia, recently announced that it has received approval for the third and final stage of the second Phase I trial of its lead Alzheimer’s drug candidate Xanamem™.

Xanamem™ blocks the development of cortisol, which appears to contribute to cognitive impairment and neurological plaques. The company is currently undertaking a second Phase I multiple ascending dose trial in humans with results expected by mid-2015 and plans to begin a Phase II study in late 2015.

The Phase I study is being conducted at the Linear Clinical Research in Perth, Australia, and aims to assess the CNS pharmacokinetics of Xanamem™. The trial will involve the recruitment of four healthy volunteers, and its primary endpoint is to determine if the drug can be efficiently delivered to the brain.

The second stage of the study, involving 12 participants in a fed/fasted dosing of 35mg of the drug has also been completed. Preliminary results showed that the drug is safe and tolerable even at the highest dose of 35mg twice per day.

The company also announced the ongoing of dosing in the final pre-clinical toxicology trial and expects to have results before the end of 2015. These results will support the Phase II clinical trial of Xanamem™ in patients with Alzheimer’s disease.

The results will also support the application for an FDA Investigational New Drug (IND) later in 2015 for the Phase II trial to be conducted in the United States. The company will also conduct the study in the United Kingdom, Australia and New Zealand, which is expected to begin during the first semester of 2016.

“The ongoing excellent progress of this Xanamem™ study sets us up well to start the Phase II trial of Xanamem™ in patients with Alzheimer’s disease in the first half of 2016. It is particularly pleasing to continue on-track with our development plans for this promising new treatment for Alzheimer’s disease,” concluded Actinogen Medical CEO, Dr Bill Ketelbey in a recent news release.