Alzheimer’s drug no longer a moonshot as race heats up, ASX-listed Actinogen in the running
Health & Biotech
Health & Biotech
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Drugs focusing on Alzheimer’s Disease (AD) have become one of the hottest things in biotech right now.
There are multiple ongoing clinical trials worldwide to study various drug candidates on treating AD, the most common type of irreversible dementia.
In Australia, ASX-listed Actinogen (ASX:ACW) is leading the charge as it too announced a positive readout from its Phase 2a clinical trial last week.
Actinogen’s share price jumped by as much as 50% as results from the trial showed that lead asset Xanamem had a therapeutic effect in patients with AD, indicated by an elevated level of their pTau biomarkers.
Elevated blood pTau is regarded as a promising new method to identify patients with the AD type of dementia likely to progress to more severe disease.
These latest results have validated Actinogen’s Xanamem program as the company prepares to use the CDR-SB rating (a widely used dementia scoring system) in the upcoming Phase 2b trial.
The Alzheimer’s community was rocked in June last year when Nasdaq-listed Biogen announced that the US FDA had granted accelerated approval for its Aduhelm (aducanumab) drug.
It was billed as the first and only AD treatment to address the disease by reducing amyloid beta plaques in the brain.
We’ve known for more than 100 years that a plaque buildup in the brain caused by lumps of amyloid-beta protein was the main cause of Alzheimer’s disease.
This was in fact discovered by psychiatrist Alois Alzheimer himself back in 1906, when he noticed distinctive plaques in an autopsy of a 50-year-old woman who suffered from memory loss, hallucinations, and delusions.
But since then, the medical community has struggled to come up with a drug that could reduce these amyloid beta plaques in the brain, until Biogen’s announcement.
Biogen CEO, Michel Vounatsos, said at the time: “This historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease.”
“We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come.”
But since that announcement, Aduhelm has been a spectacular failure commercially due to the pushback from the scientific community.
Experts have been unconvinced about the drug, saying that the FDA’s approval has raised concerns on alleged scientific disputes within the FDA itself where its own advisory committee had voted against approval of the drug.
There were also concerns about an alleged inappropriate use of the accelerated FDA pathway to gain the approval.
But Biogen has since moved forward and resurrected its hopes for an Alzheimer’s drug by launching another drug, lecanemab, into clinical trials.
In September, the company announced that its Phase 3 Clarity study on lecanemab has met its primary endpoint, which was to demonstrate highly statistical reduction of cognitive decline in a population of 1,795 participants with Alzheimer’s.
All secondary endpoints of the trial were also met, with abnormal incidents reported during the study falling within expectations.
The results were once again hailed as a ‘historic moment for dementia research’.
These are the biotechs which have programs or products that touch on Alzheimer’s – either through drug discovery or diagnosis platforms.
NSB has successfully transitioned into clinical trials for its lead drug, peptide based compound, EmtinB, which was designed to treat neurodegenerative conditions like Multiple Sclerosis and Alzheimer’s disease.
EmtinB is said to have potential because it uses a novel mode of action to harness the body’s own defence mechanisms and combat the progression of the disease.
Instead of focusing on assumed processes of the disease itself, NSN is developing a potential solution by targeting the cells that are directly affected by these diseases and stimulating survival mechanisms that allow the affected cells to withstand the damaging consequences of these diseases.
An early-phase clinical trial is now underway, which aims to develop biomarker data from human blood samples.
PainChek is not developing an Alzheimer’s drug per se, instead its main product is an app that utilises AI and smartphone technology to analyse facial movements, vocalisations, and other behaviours indicative of pain.
According to Dementia Australia, the changes in the brain that occur in people with Alzheimer’s disease and other forms of dementia do not cause pain.
However, people living with dementia are at an increased risk of experiencing pain as they are more likely to suffer from age-related medical conditions and are more prone to accidents and injuries.
Research has shown that pain affects people with dementia in much the same way as people without dementia.
A study conducted in Melbourne used MRI technology to examine brain activity in people with Alzheimer’s disease found that pain-related brain activity occurred in the same regions as those without Alzheimer’s disease.
Some of the non-verbal signs of pain the PainChek platform can detect include: facial grimacing, moaning with movement, anger, aggression, irritability, and agitation.
Cogstate also does not have a Alzheimer’s program as such, but the company is expected to benefit from Biogen’s success.
This is due to its agreement with Japanese biotech Eisai in 2020 to grant Eisai rights to exclusively develop and distribute Cogstate’s digital cognitive assessment technologies in worldwide markets.
Such digital cognitive assessments will play an important role in supporting the types of large-scale cognitive assessment that will be necessary in the launch of disease modifying therapies such as Biogen’s lecanemab drug.
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These are vital processes which are involved in the development and progression of various neurological diseases, including Autism Spectrum Disorder (ASD), Cerebral Palsy, Attention Deficit Hyperactivity Disorder (ADHD), Multiple Sclerosis, and Alzheimer’s Disease.
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