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Pharma Tech Outlook | Wednesday, April 07, 2021
REGEnLIFE's non-invasive technology tested in a clinical trial is based on photobiomodulation and targets both the brain and the gut through a helmet and an abdominal implant.
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FREMONT, CA: REGEnLIFE, a company specializing in the production of advanced photo-medical solutions for the prevention and treatment of neurodegenerative diseases, has announced a pilot clinical trial's promising results evaluating its technology in Alzheimer's disease (AD). Professor Jacques Touchon, the trial's scientific advisor, presented the findings at the 15th International Conference on Alzheimer's and Parkinson's Diseases (AD/PD 2021), which was held online from March 9 to 14, 2021.
REGEnLIFE's non-invasive technology tested in a clinical trial is based on photobiomodulation and targets both the brain and the gut through a helmet and an abdominal implant. RGn530 is a cutting-edge medical system that improves cognitive functions and behavior by activating cells in the brain and gut and regulating inflammation. It helps to minimize inflammation in the gut-brain axis, which is thought to play a role in developing Alzheimer's disease and other neurodegenerative diseases.
Adult volunteers with mild to moderate Alzheimer's disease, aged 55 to 85, were enrolled in the study. They wore a helmet and wore a photobiomodulation abdominal belt; the patients received a total of 40 sessions, each lasting 25 minutes and spread out over two months. During the trial and for one month after treatment, the participants were subjected to a battery of tests. Owing to the COVID-19 pandemic, this double-blind, randomized, monocenter, placebo-controlled clinical trial began in 2018 and ended prematurely in 2020. Out of the 64 expected patients, 53 were randomly allocated to one of two classes (treated or placebo), and 43 obtained the full benefit of the procedure.
The primary efficacy outcome was the change in total ADAS-Cog score (Alzheimer's Disease Assessment Scale) from the start to the end of the two-month treatment period. The REGEnLIFE RGn530 system has been proven to be healthy, with no significant side effects identified. The overwhelming majority of patients attended all of their treatment sessions (92 percent). Besides, this level of compliance also demonstrates the device's high tolerance. Although the primary efficacy endpoint was not statistically reached, a collection of cognitive functions showed a strong improvement trend. REGEnLIFE's technology was found to be safe and well-tolerated by patients in this pilot study. This very encouraging safety and efficiency results will now be confirmed in a pivotal or phase III clinical trial.
"The therapeutic strategy for AD should involve several targets. Drug treatments targeting the two characteristic proteins of the Alzheimer's process (beta-amyloid and tau proteins) must be supplemented by other therapies - targeting less specific but very important mechanisms in the pathophysiological AD cascade, such as inflammation and oxidative stress," said Professor Jacques Touchon, neurologist and psychiatrist, scientific advisor on the clinical trial. "REGEnLIFEs photobiomodulation technology acts at the early stages of this cascade, (mitochondria, inflammation, oxidative stress), and could be the non-drug complement to the next-generation therapeutic strategy. This technology also makes it possible to act on both the brain and the gut, a significant advantage when we know the important role of the gut-brain axis and microbiota in neurodegenerative pathologies."
A distinctive photobiomodulation technology for the treatment of Alzheimers disease
Photobiomodulation is based on near-infrared photonic emissions and has already demonstrated analgesic, anti-inflammatory, and healing properties. The overall reduction in inflammation, especially in the brain, is one of the most repeatable results. REGEnLIFE's technology could thus be used to treat brain diseases and neuroinflammation-related pathologies. REGEnLIFE developed this system using a scientific method and medical technology that had never been used in neurology before.
"There are increasing scientific data to endorse the hypothesis that the gut-brain axis is involved in the development of AD and other neurodegenerative disorders; we also believe that some forms of electromagnetic emissions could prevent and treat this disease. Our initial clinical data, coupled with all our preclinical proof of concept studies, led us to pursue a pivotal clinical study in AD and to consider working on other neurological diseases," said Guillaume Blivet, Co-founder and President, REGEnLIFE. To accelerate this new phase in our development and to shortly gain early market access, we are preparing a new funding round before the end of 2021."
Alzheimer's Disease International estimates that 35 million people worldwide suffer from the disease. The disease's annual expense is projected to be 850 billion dollars ($1.02 trillion). There are currently no cures for Alzheimer's disease. REGEnLIFE wanted to create a non-invasive technology with low patient restrictions to solve public health concerns related to a disease that affects the elderly and disabled. For patients and national healthcare systems, the cost of this device is expected to be fair.
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