ADmit Therapeutics' technology is based on an algorithm capable of stratifying patients with mild cognitive impairment (MCI) according to their likelihood of progression to Alzheimer's disease (AD) through epigenetic analysis of mitochondrial DNA in a patient's blood sample. There is a clear need for individualized prognosis of progression from MCI to AD dementia. The use of this technology by pharmaceutical companies to optimize patient selection has the potential to reduce the time and costs associated with clinical trials, increasing the possibility of identifying new effective therapies for AD. We talked about it with Marta Barrachina, co-founder and CEO of ADmit Therapeutics.
The first challenge that a neurologist faces is to obtain a diagnosis of probable AD, given that the definitive diagnosis is not obtained until a neuropathological study of the patient's brain is performed once the patient has died. The clinical diagnosis is obtained after performing a series of neurological and neuropsychological tests, an analysis of the brain using radioimaging techniques, and in most cases, a lumbar puncture where a series of protein biomarkers are quantified, including ß-amyloid. , a protein that accumulates in the brain of these patients.
Once the diagnosis of probable AD is established, the treatments offered to date are symptomatic, that is, they improve the symptoms of the disease, but do not stop its progress. A window of hope has recently opened with the first drug approved by the FDA in the United States that has been shown to slow cognitive decline in these patients by reducing levels of brain ß-amyloid. However, its approval in Europe has not yet been obtained and the next step is to be able to establish how its administration will be managed, since it is an intravenous medication and requires recurrent clinical monitoring through brain radioimaging analysis.
An early diagnosis for this neurodegenerative disease is an unmet medical need, and as already mentioned, an accurate diagnosis is the key to the success of clinical trials and for future preventive treatments. Currently, a diagnostic test has been launched on the market that allows quantification of ß-amyloid levels in the blood with a precision very similar to the levels obtained in the brain using PET radioimaging.
However, there is no technology that allows us to offer a probability of progression to AD dementia as ours does in patients with MCI. These patients are the ones who present the first memory complaints and make their first visit to the neurologist. Additionally, our blood test is highly scalable because we use next-generation sequencing techniques, whose equipment is widely deployed in clinical diagnostic laboratories.
Good science and good equipment. The first dates back to 2011, when the project began in my research group at the Bellvitge Biomedical Research Institute (IDIBELL). I became interested in studying mitochondrial DNA methylation, when I realized that there had been no scientific publication for 30 years since it had been characterized in mouse and hamster cells. Our study was intentionally focused in a very specific way, we were looking for needles in a haystack, unlike the traditional approach to DNA methylation research, which uses commercial platforms that only offer information on specific regions of the DNA of our chromosomes without obtain information from mitochondrial DNA.
Based on the results obtained in postmortem brains of patients with AD and with different degrees of involvement, we patented the results and published them in an international scientific journal. So we started the clinical study on blood samples from MCI patients and the company was founded. The second basis of our work and the most important is, without a doubt, our team. We are a multidisciplinary team made up of molecular biologists, mathematicians, engineers, computer scientists and neurologists.
We are all very aware that we are developing a technology that does not yet exist on the market, that is, a prediction platform based on novel biomarkers in the field of AD and obtained with machine learning techniques. This is a challenge for the team, and is a great intellectual motivation due to the health and economic impact it can represent worldwide.
We have just closed a capital increase of €5.4 million led by Clave Capital, a Spanish venture capital fund and with the participation of the European Innovation Council fund (EIC Fund), the Alzheimer's Drug Discovery Foundation (ADDF) Diagnostic Accelerator ( DxA) in New York, and other investors such as Lavanda Ventures, Ship2B and WA4Steam. This investment allows us to complete the clinical validation of our medical product and consolidate the regulatory map in Europe and the United States, that is, obtain approval from regulatory agencies to begin marketing.
