New Alzheimer’s treatment on horizon as dementia reversed for first time in dogs

Media release Sydney, Australia, 21 June, 2022  Australian biotech Skin2Neuron Pty Ltd (S2N) has achieved what no one else has to date – reversal of a dementia-like syndrome in a natural animal form of Alzheimer’s disease.

With the once dominant amyloid hypothesis of Alzheimer’s disease suffering yet another crushing blow this week, the field is desperate for a ray of hope. Enter S2N, a new Australian biotech pioneering an all-new neurorestorative approach, aiming to rebuild and replace the lost brain cells in Alzheimer’s that underlies clinical symptoms. 

In a world first, a veterinary trial led by S2N suggests the audacious concept may work. S2N’s new form of cell therapy reversed the dementia-like syndrome that strikes down many older pet dogs with Alzheimer’s.

Co-founder Professor Michael Valenzuela explains, “Because of deep parallels between the canine brain and human brain, and canine Alzheimer’s and human Alzheimer’s, I started this trial 10-years ago with the assumption that if it’s going to work in humans then it needs to work in dogs first. And the results exceeded my wildest expectations.”

Dementia was reversed in more than half of the canine patients, with a clinically meaningful improvement in 80%. For many of the carers it was a life-changing turnaround, some at the point of considering euthanasia before treatment.

Fiona Gibbs, carer of Leo, a 12-yo Pomeranian in the trial, describes the impact, “Before treatment, Leo was really bad, forgetting who we were, getting lost, and having these unpredictable episodes where he would growl and snap – it was really scary and we just couldn’t go on. A few months after treatment he started getting better, and then he was back to his normal self, and we look back at the movies and think, ‘wow, was he really that bad?’”. [See video of Leo before and after]

Leo’s life-changing improvement lasted almost two years, typical of clinical recovery in the trial.

And when Valenzuela looked in the brain, the findings were remarkable, “The hippocampus, the memory centre of the brain, was packed with baby neurons and new synapses, precisely where we delivered the cells. Compared to untreated dogs it was like night and day”.

Importantly, microscopic analysis confirmed the dogs had classic Alzheimer pathology. In other words, the cell therapy worked in the setting of natural disease, a first of its kind.

(A) Microscopic image of hippocampus (memory centre) from an older dog with the dementia-like syndrome successfully treated with S2N’s therapeutic cells. The hippocampus is packed with green cells that are new neurons (brain cells) and yellow dots, new synapses (connections between brain cells). Blue marks out nuclei of individual cells. (B) Same brain area in an older untreated dog. There are no new neurons (no green cells), a few red dots (old synapses), but no new synapses (no yellow dots).

“Given our doggie patients also had many of the same health issues that older people face, it gives me even greater confidence,” says Valenzuela.

Stem cell pioneer Professor Brent Reynolds of the University of Florida, not connected to the study, considers it a landmark in the quest to treat to brain degeneration. “Alzheimer's is an area of medicine that needs new thinking. What stands out are clinically meaningful outcomes in a natural canine model of this devastating disease. Also, the company’s approach to generating cells from the same patient could solve many of the problems facing cell therapies.”

The study helps pave the way for S2N to launch a world-first human trial in 2024.

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About Skin2Neuron

Skin2Neuron Pty Ltd is a private company located in Sydney, Australia, whose ethos is Creative Biotech.

S2N is pioneering an all-new class of neurorestorative cell therapy for Alzheimer’s disease and other brain disorders based on its proprietary hair follicle-derived neuroprecursor technology.

S2N was co-founded by seasoned entrepreneur Bill Manos and prize-winning Alzheimer researcher Professor Michael Valenzuela. Along the S2N journey, Valenzuela invented not only the cell manufacture technology, but also a predictive biomarker, an automated memory testing system, and introduced canine dementia to the field as a new translational animal model.

S2N’s is headquartered in Surry Hills and has a research & development laboratory at Macquarie University.

About Alzheimer’s and Dementia

Dementia is an exclusively clinical term encompassing the observable syndrome of progressively declining memory and other cognitive abilities, to the extent the person can no longer carry out day-to-day tasks. There are an estimated 55M people with dementia around the world, with accelerating forecasts because of the ageing population, especially in developing countries. Alzheimer’s Disease International estimates that worldwide there is a new case of dementia every 3 seconds and that dementia accounts for ~US$1.3 trillion of economic burden each year, equivalent to the GDP of Australia.

Dementia is caused by one of many brain diseases, the most common being Alzheimer’s. The biological cause can be inferred by a person’s clinical pattern of symptoms, or more directly and accurately by sophisticated brain imaging, or by microscopic examination of the brain after death. It is possible, and even common, for someone to have Alzheimer’s disease in their brain but no dementia, and vice versa, to have dementia but no Alzheimer’s.

Currently, there is no clinically effective treatment for dementia caused by Alzheimer’s disease. On June 16 2022, Roche announced that their latest Phase 2 trial of crenezumab, an anti-amyloid vaccine, had failed to prevent clinical decline in early onset (familial/genetically determined) Alzheimer’s.