USA News Group – According to a 2022 study of more than 6 million patients 65 and older, the risk factor for developing Alzheimer’s disease increases by 50-80% in older adults who caught COVID-19. With Statista stating nearly 11.5 million COVID-19 cases of people over 65 years old as of November 23, 2022, and the Alzheimer’s Association forecasting global dementia cases to triple by 2050, society is about to get hit with a tsunami of this devastating disease. Thankfully the biotech sector is working diligently to try and combat this coming onslaught of Alzheimer’s and dementia, through new diagnostic methods and treatments, including work from companies such as Marvel Biosciences Corp. (TSXV:MRVL), Biogen Inc. (NASDAQ:BIIB), Prothena Corporation plc (NASDAQ:PRTA), Intra-Cellular Therapies (NASDAQ:ITCI), and Roche Holding AG (OTC:RHHBY).
In the case of Marvel Biosciences Corp. (TSXV:MRVL), the biotech company is moving forward with its lead asset MB-204 in targeting Alzheimer’s and depression. MB-204 is a novel fluorinated derivative of Istradefylline, the only clinically approved adenosine A2a receptor antagonist used for the treatment of Parkinson’s disease.
Both Istradefylline and MB-204 are highly active derivatives of caffeine, the most widely consumed psychoactive drug in the world. Caffeine consumption has been associated with a reduced risk for developing Parkinson's disease, Alzheimer's disease and improving mood and concentration.
Through Marvel Biotechnology, its wholly-owned subsidiary, Marvel BioSciences initiated its 7-day dose-ranging, toxicology study, using rats, for MB-204, marking a vital step in preparation to initiate FDA Phase I human clinical trials.
"We have significantly de-risked the development of our lead drug candidate MB-204 and have a strong understanding of its safety and risk profile, as we have redeveloped this candidate from an existing FDA-approved drug Istradefylline," said Rod Matheson, CEO of Marvel Biosciences. "We are on time and on budget to enter FDA Phase I human trials by early 2023. MB-204 will be highly disruptive to the existing market and, we believe, will be a welcomed therapy for patients who suffer from Alzheimer's Disease and Depression. Our studies, as noted in previous press releases, have been extremely encouraging and we look forward to introducing a novel product that we have full commercial rights to for a very large and growing market that is in real need of a new and effective approach to treatment."
After completing the maximum tolerated single dose studies, the FDA requires another short study before entering the industry standard Good Lab Practice toxicology studies. This type of study requires toxicology studies in two species, typically rats and dogs, to test the safety of new drugs before being able to run trials on humans.
"This is the final milestone experiment we need to execute in order to identify the optimal doses for our upcoming 4-week GLP rat study, which in combination with our dog studies, will allow us to start human clinical testing of MB-204," said Dr. Mark Williams, Chief Science Officer of Marvel BioSciences. "We are commencing the dog dose ranging study shortly and will update the market on our progress shortly thereafter."
Through partners Eisai Co., biotech company Biogen Inc. (NASDAQ:BIIB) recently announced the full results from a Phase 3 Confirmatory Clarity Ad Study of Lecanemab for the treatment of Early Alzheimer’s Disease.
Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.
What the closely watched trial showed was a slowing of cognitive decline, however also may carry a risk of serious side effects for certain patients, including bleeding in the brain.
"All of these amyloid-lowering drugs carry a risk for increased brain hemorrhage," said Dr. Ronald Petersen of the Mayo Clinic in Rochester, Minnesota. "I think the primary outcomes, the secondary outcomes, the amyloid-lowering is pretty impressive."
Prothena Corporation plc (NASDAQ:PRTA) is currently testing an amyloid-targeting shot, which RBC Capital Markets analyst Brian Abrahams says “from a profile standpoint (Prothena’s drug) is significantly more potent.”
Prothena’s Alzheimer’s disease portfolio spans next generation antibody immunotherapy, small molecule and vaccine approaches, geared toward building upon first generation treatments to advance the treatment paradigm.
The company has initiated a Phase 1 study of PRX012, a potential best-in-class, next-generation anti-amyloid beta (Aβ) antibody under investigation for the treatment of Alzheimer’s disease. Back in April, PRX012 was granted Fast Track designation by the FDA.
“With its substantially higher binding strength that allows for simple subcutaneous administration, PRX012 is positioned to potentially lead a paradigm shift in Alzheimer’s treatment,” said Gene Kinney, CEO of Prothena.
Dealing with the behavioral disturbances associated with dementia and Alzheimer’s Disease is a goal for Intra-Cellular Therapies (NASDAQ:ITCI). One of the company’s ongoing programs is its ITI-1284-ODT-SL program, which is a deuterated form of lumateperone.
Intra-Cellular expects to commence clinical conduct in Phase 2 clinical trials in agitation in patients with probable Alzheimer’s disease, in dementia-related psychosis and certain depressive disorders in the elderly in 2023. However, ITI- 1284 is still an investigational agent and has not been approved for use for any indication.
A Phase 1 program found that ITI-1284 ODT-SL was rapidly absorbed into the systemic circulation, was metabolically stable, and resulted in high systemic exposure.
"We are excited about our late-stage lumateperone programs in depressive disorders and the advancement of a long-acting injectable formulation into clinical trials as well as further expanding our pipeline with ITI-1284,” said Sharon Mates, PhD, Chairman and CEO of Intra-Cellular Therapies.
Helping to diagnose Alzheimer’s disease more accurately and in a more timely fashion, Roche Holding AG (OTC:RHHBY) received FDA clearance for its Elecsys Alzeheimer’s disease (AD) CSF assays. Currently, the diagnosis of Alzheimer’s is a diagnosis of exclusion, largely based on various cognitive tests, routine laboratory tests and structural imaging (MRI or CT scan).
Clinical criteria are currently limited and lead to an accurate diagnosis in only 70-80% of cases, whereas the Elecsys AD CSF assays achieve 90% concordance with the Amyloid PET scan imaging, and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid in the brain.
“Globally, up to 75% of people living with Alzheimer’s disease have not been diagnosed, and those who have, often report a long and complicated process5,” said Thomas Schinecker, CEO of Roche Diagnostics. “The Elecsys AD CSF assays have the potential to guide more people with suspected Alzheimer’s disease towards a diagnosis than ever before. As we are starting to see exciting results for new potential Alzheimer’s treatments, reliable tests that have been clinically validated will be critical in ensuring the right patients are identified and able to benefit from them.”
Article Source: https://usanewsgroup.com/2022/12/05/the-art-of-repurposing-safe-off-patent-drugs-for-more-profitable-diseases/
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