ADmit Therapeutics Has Developed a Breakthrough Alzheimer’s Biomarker Test Based on Epigenetics
Under CEO Marta Barrachina, PhD, ADmit Therapeutics has developed a promising new blood test for the early detection of Alzheimer’s disease that could help make Alzheimer’s clinical trials more efficient and effective.
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Challenge
Most people think about Alzheimer’s disease as a series of visible symptoms, like memory loss and mood changes.
These symptoms exist on a spectrum, and when a person – or their loved one – notices the early signs of these symptoms, they might go to their primary care physician and get a diagnosis of mild cognitive impairment (MCI).
Patients with an MCI diagnosis have no idea if their small signs of decline are harbingers of full blown Alzheimer’s or dementia. In decades past, this wasn’t a huge issue, because there was precious little that could be done to slow the progression of the disease. In some cases, it felt like less knowledge was better.
But that’s all changing. Today there are therapeutics and treatments that can slow the progression of Alzheimer’s, and there is even serious work being done on a cure.
Pharmaceutical companies are going all-in on Alzheimer’s clinical trials, but these studies come with huge enrollment challenges.
According to a white paper put out by UCS Schaffer, “Alzheimer’s trials tend to be slower to enroll participants, take longer to complete, and are more expensive than trials in most other therapeutic categories. In fact, approximately 99% of eligible patients are never referred to or consider participating in an AD clinical trial.”
One of the barriers to Alzheimer’s clinical trials is that screening for appropriate patients is expensive and time-consuming. To date, screening has included MRIs, PET scans, and spinal taps. Adding insult to injury (spinal taps are painful and not tolerated by everyone) preclinical Alzheimer’s trials have a screening failure rate – the percent of subjects who go through screening but don’t meet the enrollment criteria – of 88%.
A group of scientists in Spain are on a mission to change this paradigm – and help pharmaceutical companies develop therapies faster – by making Alzheimer’s testing more accurate and predictive.
Origin Story
Marta Barrachina is a biochemistry PhD who began her career at the Bellvitge Biomedical Research Institute in Barcelona. She worked her way up the academic ladder, as a principal investigator and then on a team with renowned neuropathologist Isidro Ferrer.
But she had discoveries of her own to make about the biochemistry of the brain. So she went to the source, analyzing post-mortem human brains from biobanks.
Through their work, Dr. Barrachina and her team successfully identified a series of epigenetic biomarkers that link mitochondrial activity to Alzheimer’s disease. The reason this was important, explains Barrachina, is that mitochondrial dysfunction has been described as one of the first events in the progression – or etiopathogenesis – of Alzheimer’s disease, happening even prior to the appearance of beta amyloid and tau proteins. As their findings are related to mitochondrial DNA, they have been viewed as promising biomarkers for the disease.
Their discovery opened the door to the possibility of predicting Alzheimer’s progression years in advance, by looking at activity at the cellular level, rather than waiting for physical signs of plaque to show up on the brain. It’s a prognosis, or disease forecast, not merely a snapshot of current symptoms.
Barrachina presented her findings to her innovation unit, and they pushed her to validate and patent it – and then share it with the world.
She knew that she was on to something special, something that could change patients lives by giving them early detection for cognitive diseases. But she also knew how easy it was for research to get lost in peer-reviewed journals.
“Our results were quite robust, but I saw clearly that if I didn't do that change in my professional career, that our findings wouldn't reach patients,” says Barrachina. She decided to get an MBA and find two co-founders who could help her bring her discoveries out of the lab and into the patient-care setting.
“My motivation and the motivation of my team is the clinical impact. I'm aware that I have to assure the return of investment to my current investors, but the motivation is not a business motivation.”
Under the Hood
For ADmit, it all starts in the mitochondria, which Barrachina explains are “like the lungs of the cells. It's where the energetic metabolism occurs.” This is where the very first events of nearly all neurogenic diseases take place, “because without energy, the neuron or the glial cells cannot survive.”
Barrachina and her team first discovered the connection between mitochondrial DNA and Alzheimer’s disease in the actual postmortem brains of patients at different stages of the disease. But then they moved the analysis to blood samples in order to make the biomarkers useful for clinical practice.
After concluding their first clinical validation, ADmit was able to predict the progression of Alzheimer's disease and dementia in patients with mild cognitive impairment. In patients with early memory loss complaints, they were able to categorize patients into those who will progress to Alzheimer’s disease dementia or those who won’t.
“Based on our data, we can predict up to 14 years before the appearance of Alzheimer's dementia,” says Barrachina. “We have better results – accuracy, sensitivity, specificity – than current scans.”
Just how much better is what Barrachina will be proving out in their next clinical validation and in their FDA process.
Our Take
Marta Barrachina, PhD, and her team at ADmit are on the cusp of the kind of scientific breakthrough that could completely change how we look at Alzheimer’s. Current options for visualizing Alzheimer’s disease, like the PET scan, give patients a snapshot of a moment in time but don’t offer much information on what’s to come. Patients get a diagnosis not a prognosis. And with more and more therapies coming to market that can slow the progression of Alzheimer’s, catching it early can gain a person years of quality life.
Patients will also be pleased to be able to gain data on disease progression through a blood test. ADmit positions itself as a good first line of defense, democratizing access to Alzheimer’s testing by sidestepping costly PET scans and highly invasive spinal taps.
But it’s not just about individual patient care. ADmit’s breakthrough is even more useful at a macro-pharmaceutical level. They believe that their test could improve the ease and accuracy of the Alzheimer’s disease testing required during clinical trials, thereby making those trials significantly more successful.
Barrachina and her team are currently working on CE Mark approval in Europe and are holding meetings with the FDA. Their team of 11 has raised $10 million and counts among their advisors Dr. Russell Swerdlow, considered the father of the theory of the mitochondrial cascade in Alzheimer’s disease.
The next task is to increase their sample size with more patients from the United States. Much of the hard science has been done, the discoveries patented. Now Barrachina and her team have to complete validation studies and start shouting their story from the rooftops.
Join us in welcoming Marta Barrachina, PhD and the ADmit team to StartUp Health’s Alzheimer’s Moonshot.
Connect with ADmit Therapeutics via email
Call for Alzheimer’s Innovation
With support from the Alzheimer’s Drug Discovery Foundation (ADDF) and Gates Ventures, we’ve launched a new global initiative created to develop a collaborative innovation community alongside leading companies, research teams, and stakeholders with a mission to accelerate progress in prevention, diagnosis, and management of Alzheimer’s disease and related dementias. Learn more and apply for an Alzheimer’s Moonshot Fellowship.
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Published: Aug 1, 2024