• Dementia has become Australia’s number one disease burden
  • Companies globally are now racing to discover new drugs for neurodegenerative diseases
  • Stockhead reached out to Alterity Therapeutics’ CEO, David Stamler 


Dementia has overtaken coronary heart disease as the leading cause of disease burden among Australians aged 65 and over.

That’s the latest update from the Australian Institute of Health and Welfare’s (AIHW), which added that the number of Aussies who live with dementia will double by 2058.

The AIHW report also said that dementia was responsible for almost 230,000 years of healthy life lost in 2022, which is a staggering 61% increase since 2011.

David Stamler, CEO of ASX-listed neurodegenerative disease specialist Alterity Therapeutics (ASX:ATH), told Stockhead the increase and prevalence of diseases like Alzheimer’s (AD) and Parkinson’s (PD) can be attributed to many factors.

“Age is of primary importance, as the risk of both AD and PD are known to increase with age, and people are now living longer,” Stamler said.

“In addition, there is more awareness as more novel treatments are approved, and this leads to earlier screening among treating clinicians.

“Environmental and genetics may also be contributing factors, but that is more difficult to determine,” he added.


Are infections the cause of Alzheimer’s?

Up to this point, research into the disease has focused on plaques in the brain.

But now, some scientists think viruses and bacteria may in fact play a role in causing the disease – and their work is starting to be recognised.

New evidence has pointed towards the herpes simplex virus 1 (HSV-1), a pathogen that causes of oral herpes, as a prominent suspect.

These recent studies suggest that people who had been infected with herpes were more likely to get Alzheimer’s disease.

A 2018 study from Taiwan further confirmed that when people with herpes were treated with a standard antiviral drug, it decreased their risk of dementia nine-fold.

“The data on herpes virus are intriguing,” Stamler said.

“The Taiwan study showed a clear association of HSV infection and dementia, and also that antiviral treatment for HSV reduced the risk.”

But while potential links between the virus and neurodegenerative disease risk exist, experts pointed out a causal link cannot yet be confirmed.

“Association is not causation, so it can’t be conclusively determined that HSV was a critical environmental factor for increasing the risk of Alzheimer’s,” Stamler said.


Alzheimer’s drug discovery is booming

Over the last couple of years, drugs focusing on Alzheimer’s Disease have become one of the hottest things in biotech.

There are multiple ongoing clinical trials worldwide to study various drug candidates on treating AD, the most common type of irreversible dementia.

The deluge was triggered by a historic breakthrough in June 2021 when Nasdaq-listed Biogen was granted an accelerated FDA approval for its Aduhelm (aducanumab) drug, billed at the time as the first and only AD treatment.

Although sales of Aduhelm have flopped due to various controversies, Biogen has resurrected its hopes for an Alzheimer’s drug by launching another one called Leqembi (lecanemab). Laqembi has now been FDA approved based on its Phase 3 trial readout.

Despite these advances, Stamler said a lot of work still needs to be done such as finding complementary drugs that could improve standard of care.

“We haven’t found a cure but progress is being made incrementally and that is important,” Stamler said.

“Treatment of complex diseases like Alzheimer’s will likely require several complementary treatments that target different aspects of the underlying pathology.”


Alterity’s Parkinson’s Disease program

Parkinson’s disease (PD) meanwhile is the second most common neurodegenerative disease after Alzheimer’s disease.

Alterity’s current Phase 2 trial on ATH434 is one of the most advanced programs for PD on the ASX.

The trial is studying the treatment of MSA, a debilitating Parkinsonian disorder which is also called Parkinson’s Plus.

Patients who suffer from Parkinson’s Plus have Parkinson’s symptoms along with other debilitating symptoms – a condition that currently has no approved treatment.

ATH434 meanwhile is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration.

It has been shown preclinically to reduce α‑synuclein pathology and preserve nerve cells by restoring normal iron balance in the brain.

ATH434 has been granted Orphan designation for the treatment of MSA by the US FDA and the European Commission.

The Phase 2 trial will be focusing on biomarkers (on MRI and in blood and spinal fluid), and clinical symptoms that are important in MSA.

“Because the selected biomarkers contribute to MSA pathology, they will give us an early indication that our drug has potential to slow disease progression,” said Stamler.

The company has recently received a regulatory approval to proceed with the ATH434 Phase 2 Clinical Trial in Austria and France.

It has ongoing partnerships with organisations like Vanderbilt University and the Michael J Fox Foundation for Parkinson’s Research in the US.

“Over the coming months, we expect to expand our Phase 2 trial of ATH434 for MSA into other countries and continue to enroll patients in the trial. Our goal is to enroll 60 patients globally,” Stamler said.


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Other ASX stocks with neurological disease programs

Neuren Pharma (ASX:NEU)

Neuren is developing new therapies for debilitating neurodevelopmental disorders that emerge in early childhood.

The company owns two novel drugs, treating six neurodevelopmental disorders, all with Orphan Drug designation.

Meanwhile, the US FDA is expected to decide on March 12 whether it approves Neuren’s trofinetide for Rett’s syndrome.

If the drug is approved it will be a game-changer financially for the biotech.

Emyria (ASX:EMD)

Emyria has made strides in its MDMA psychedelics program with the Western Australian University (UWA) that aims to establish a large MDMA candidate library.

The priority areas include mental health disorders and neurological disorders such as Parkinson’s disease.

The library now comprises over 120 novel MDMA-like compounds, with three drug discovery priority areas identified.

Actinogen Medical (ASX:ACW)

In December, Actinogen received the green light from the US FDA to proceed with its six-month, Phase 2b, placebo-controlled clinical trial of Xanamem in patients with early stages of Alzheimer’s Disease (AD).

The planned Phase 2b trial will enrol 330 patients with mild AD and progressive disease, who will be randomised to treatment over six months with 5mg, 10mg of Xanamem or placebo once a day.

Living Cell Technologies (ASX:LCT)

NTCELL is an investigative disease-modifying therapy for Parkinson’s disease under development by Living Cell.

The unique cell therapy consists of a capsule that contains newborn choroid plexus cells from pigs without pathogens bred from a stock discovered in the sub-Antarctic Auckland Islands.

Neuroscientific Biopharma (ASX:NSB)

NSB develops peptide-based drugs that target a number of neurodegenerative conditios.

The company has successfully transitioned into clinical trials for its lead drug, peptide based compound, EmtinB, which was designed to treat conditions like Multiple Sclerosis and Alzheimer’s disease.


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