The Alzheimer's drugs market was valued at USD 7.7 billion in 2023, driven by the increasing aging population and rising awareness about Alzheimer's disease and related dementia across the 8 major markets. The market is expected to grow at a CAGR of 5.3% during the forecast period of 2024-2032, with the values likely to reach USD 12.3 billion by 2032. Therefore if successful later this year when interim results in Xanamem’sphase 2b/3 clinical trial are announced, the skys the limit when It comes to ACW’s share price.
But why do Actinogen think Xanamem is going to produce strong interim results? Well I guess it comes back to peer reviews highlighting Xanamem’s success in treating patients with elevated levels of the stress homone P tau in the past. Elevated levels of phosphorylated tau (p-tau) in the brain are strongly associated with the presence of tau tangles. Increased p-tau is a key biomarker for the formation and accumulation of neurofibrillary tangles, which are a hallmark pathology of Alzheimer's disease. High p-tau levels suggest a greater likelihood of tau tangles being present in the brain tissue. Xanamem, as exemplified in its recent Phase 2 trial in patients with MDDD, is shown to reduce cortisol levels in the brain. Why is this important? Research suggests that elevated cortisol levels are associated with increased levels of phosphorylated tau (p-tau), a protein marker associated with neurodegenerative diseases like Alzheimer's, indicating that chronic stress, which can lead to high cortisol, may contribute to the development of tau pathology in the brain. Research has shown that higher cortisol levels could potentially promote the accumulation of abnormal p-tau proteins, contributing to cognitive decline.
There are really two types of medication when considering treatment for Alzeihmers. Those targeting amyloids, such as the approved drug Laqembi, and those treating tau tangles. globalnewswires.com recently noted that recent trends indicate a shift towards developing disease-modifying therapies rather than just symptomatic treatments. They suggest that research is increasingly centred on drugs that target the underlying pathology of Alzheimer's, such as amyloid-beta plaques and tau tangles. This trend is driven by the need for therapies that can potentially slow or halt disease progression, offering more substantial benefits compared to existing treatments. But more recently reports are starting to emerge of the significant side effects associated with amyloid based treatments such as Leqembi, including brain swelling, bleeding and even fatalities, paving the way for drugs focusing on tau tangles. Drugs without side effects that is. Drugs such as Xanamem, which aim to treat the tau tangles responsible for blocking one’s neuron's transport system. Tau tangles harm the synaptic communication between neurons, disrupting an individuals messaging is causing the thinking difficulties that underpin dementia. Therefore if Xanamem improves messaging, working memory and cognition in the 220 or so patients enrolling in the current US and Australia based trial, then once again the resultant brain modifying behaviour could prove a paradigm shift for researchers endeavouring to treat this debilitating condition.
Lots can go wrong with clinical trials. Though by carefully screening and identifying patients with eleveated p Tau levels, Actinogen is looking to focus on participants with similar biology to those with whom they have had success treating in the past. As noted in June 2024 by the company’s Chief Medical Officer Dr Dana Hilt:
To our knowledge Xanamem is the first drug of this class to have such compelling data. The previously published PET study highlighted just how effective Xanamem is at reaching its target enzyme in the brain at safe and well tolerated doses of 5 and 10 mg/day. No other inhibitor of 11β-HSD1 has ever demonstrated robust central nervous system (CNS) target engagement in this direct way.
“This new peer-reviewed publication reports that Xanamem 10 mg potentially slows AD progression in patients with high plasma pTau181. The other trends toward benefit on cognition are consistent with our two, prior phase 1b studies in older healthy volunteers which showed improved attention and working memory.
“Further data on cognition are anticipated when the XanaCIDD trial of cognitive impairment and major depressive disorder reports results next quarter. The XanaMIA phase 2b trial in 220 patients with mild to moderate AD is on-going.”
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