Whether you’re running for the train, or running from a lion, cortisol- the stress hormone, plays an important role in making sure you aren’t late, or eaten.
Except, too much cortisol has detrimental effects to the brain and our health, with research suggesting that cortisol dysregulation can affect cognitive function and harm brain cells in the long-term.
Biotech company Actinogen Medical (ASX: ACW) is developing their lead drug, Xanamem for the treatment of the notoriously difficult to treat, and devastating Alzheimer’s Disease as well as depression. Their overarching aim is to reduce the neuropsychological burden, behavioural abnormalities and cognitive dysfunction associated with these conditions.
The oral Drug works by blocking cortisol production within the brain, therefore reducing the negative effects of excess cortisol. Early trials of the compound have shown that it can help enhance cognition in healthy, older volunteers.
The odds of developing Alziehimer’s are higher than you might think. 10% of people over the age of 65 have the disease with this increasing to as many as 50% in people aged over 85.
Despite serious unmet need, especially with an ageing population, there is only one disease- modifying drug currently approved for the treatment of the disease. The drug, called Aducanumab, is an immunotherapeutic compound that has been the subject of controversy with the FDA advisory board initially recommended to not approve the drug due to it failing one of two Phase 3 studies. There is some evidence that the drug is associated with brain inflammation and bleeding.
Despite worries about safety and efficacy, the FDA ultimately approved the drug, to which the Institute for Clinical and Economic Review said that the FDA “failed in its responsibility to protect patients and families from unproven treatments with known harms.”
Aducanumab was rejected by the European Medicines Agency with the Agency citing insufficient evidence that the drug works.
The controversy around Aducanumab means Actinogen has an opportunity to fill a serious market gap if their drug is safe and effective.
The Company is now moving Xanamem to Part B of their Phase 2 trial in patients with early stage Alzheimer’s where there is some functional impairment. Part A demonstrated that healthy patients taking Xanamem had better attention and working memory.
The six month, placebo-controlled Part B trial will see 300 patients dosed with the drug at either 5mg or 10mg treatments. Patient progress will be evaluated by using the Cogstate Cognitive Test Battery, used in Part A of their study. The test method evaluates cognitive function and multiple cognitive domains. Trial results are expected in 2024 with patient recruitment set to commence soon.
Actinogen has also finalised their trail design for a Phase 2 trial looking into Major Depressive Disorder (MDD). A smaller scale trial than their Alzheimer’s one, the MDD trial will recruit 120 patients suffering with MDD in spite of standard antidepressant treatment where Xanamem will be added to the existing treatment. The proof-of-concept trial will span 6 weeks with results expected in late 2023.
Commenting on both trials, Actinogen’s CEO, Dr Steven Gourlay said: “The results from our recent XanaMIA trial are exciting and highly confirmatory. We are now initiating two robust Phase 2 trials in patients with Alzheimer’s Disease and Depression. Xanamem has the potential to be an effective low-dose daily oral therapy for these and many conditions where it may be used alone or in combination with other treatments.”
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