Biotech company Actinogen Medical (ASX: ACW) has confirmed that it has obtained half of the required patients in order to conduct its landmark Phase 2 clinical trial of Xanamem, a drug candidate to treat Alzheimer’s disease.
Actinogen said that a total of 87 patients have been enrolled into XanADu, representing half of the total 174 patients planned for the study and adding that the trial continues to enrol on target, with the final patient expected in Q4 2018.
Actinogen then hopes to see top-line results by April/May 2019 and reaffirmed that its clinical trial is “fully funded” through to its completion.
According to Dr Robert A. Riesenberg MD, Principal Investigator (PI) of the Atlanta Center for Medical Research (ACMR), sees the ‘non-amyloid’ nature of Xanamem as a potential value driver in the future.
Xanamem’s mechanism of action sets it apart from other Alzheimer’s treatments. According to Actinogen, Xanamem works by blocking the excess production of cortisol, a known “stress hormone”, through the inhibition of the 11β-HSD1 enzyme in the brain.
This enzyme is highly concentrated in the hippocampus and frontal cortex, the areas of the brain most affected by Alzheimer’s disease.
There is a strong association between chronic stress and excess cortisol that leads to changes in the brain affecting memory, and to the development of amyloid plaques and neural death – all hallmarks of Alzheimer’s disease.
“We’re excited about the potential for Xanamem in Alzheimer’s disease, particularly as it’s not targeting amyloid. So many amyloid-related drugs under development have seen unfavourable outcomes in recent years, so it’s particularly encouraging, for us and our patients, to be trialling a drug with a novel mechanism of action,” said Dr Robert A. Riesenberg MD.
In addition to the trial, Actinogen will also have its current progress reviewed by the Data Safety and Monitoring Board (DSMB) who plan to carry out an interim analysis of the clinical trial once Actinogen has registered its 50th patient and completed the prescribed 12-week treatment period including the customary 4-week follow-up phase.
The output from the DSMB analysis is expected to be available in late May or early June this year.
“Our XanADu trial is ground-breaking in the field of Alzheimer’s drug development and it places Actinogen at the forefront of Alzheimer’s disease research,” said Dr Bill Ketelbey, CEO of Actinogen Medical.
“We’re delighted to have reached the halfway point on schedule and we look forward to completing patient enrolment later this year. We also keenly await the commencement of the interim analysis and sharing the output from the DSMB in late May or June,” he added.
