Help is on the Way as Rising Alzheimer’s Cases Highlight Urgency for New Treatments March 22, 2023 - Baystreet.ca USA News Group – It’s estimated that 6.7 million Americans over 65 (or more than 1 in 9 seniors) are now living with Alzheimer’s Disease (AD), and the number of diagnoses is on the rise. It’s expected that the burden of those affected will double over the next two decades, rising to 13 million in 2050. Couple in the fact that there’s a shortage of capable caregivers, and unpaid dementia caregiving is being valued at $340 billion, it’s obvious that new treatments and prevention are urgently needed. 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), Annovis Bio, Inc. (NYSE:ANVS), ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), Neurosense Therapeutics Ltd. (NASDAQ:NRSN), and Biogen Inc. (NASDAQ:BIIB). With its lead asset MB-204, Marvel Biosciences Corp. (TSXV:MRVL) is moving forward in targeting Alzheimer’s and depression. The strategy is built upon MB-204 being a novel fluorinated derivative of Istradefylline, the only clinically approved adenosine A2a receptor antagonist used for the treatment of Parkinson’s disease. Marvel Biosciences started 2023 having completed a critical manufacturing milestone required to enter Phase 1 human trials targeting both Alzheimer’s disease and depression, through a multi-kilogram scale run under current good manufacturing practices (cGMP). The cGMP material obtained from the study was set aside to be utilized in Marvel’s Phase 1 clinical study. As of March 2023, Marvel Biosciences announced the initiation of a 4-week good laboratory practice (GLP) FDA investigational new drug (IND) enabling dose-ranging rat studies for its lead drug candidate MB-204. "We look forward to completing these two critical studies of MB-204 and entering human trials in the coming months, which is an important value-creating milestone for Marvel and our shareholders," said Rod Matheson, CEO of Marvel Biosciences. "MB-204 to date has shown very promising results, and we believe that this asset has the potential to reduce symptoms of depression and Alzheimer's, both of which are significant and growing problems. We look forward to advancing our lead asset MB-204 through human trials and playing a pivotal role in addressing this growing addressable market." 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. By the end of February 2023, Marvel Biosciences had closed the first tranche of a non-brokered private placement that drew gross proceeds of $1,000,000 and added much appreciated capital ahead of the year’s MB-204 work ahead. Through its Buntanetap and ANVS 301 assets, Annovis Bio, Inc. (NYSE:ANVS) is targeting multiple neurodegenerative conditions, including Alzheimer’s disease. Buntanetap is officially Annovis’ lead compound, and is in a Phase 3 clinical trial for Parkinson’s Disease and Phase 2/3 for Alzheimer’s Disease—which the company published Phase 2A clinical data for in October 2022. The Alzheimer’s study demonstrated that buntanetap was well tolerated, safe and significantly improved cognition in AD patients and motor function in PD patients. "Given the short duration of our Phase 2a clinical trial, we are delighted to see that patients treated with buntanetap had a statistically significant improvement in cognition and function," said Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. "We believe that the effects on cognition and motor function after such a short treatment are due to buntanetap's ability to restore neuronal function through the improvement of axonal integrity, synaptic transmission, and reduction of inflammation." For ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), the March 2023 approval by the FDA for its drug trofinetide (to be sold under the brand name Dayblue) for the treatment of Rett syndrome came as a bit of optimism as the same regulators declined to approve expanded use of the company’s drug Nuplazid to treat psychosis related to Alzheimer’s disease. "We have put a lot of planning into potential commercialization of trofinetide, including resources for patients to access the drug," said Acadia senior executive Kathie Bishop ahead of the approval. After the FDA declined to approve the expanded use of Nuplazid, Acadia said it would no longer pursue that indication for Nuplazid any further, and shift the focus of its resources on late-stage development of Nuplazid to treat symptoms of schizophrenia and early-stage development of another candidate, ACP-204, for Alzheimer's-related psychosis. Earlier in January 2023, Neurosense Therapeutics Ltd. (NASDAQ:NRSN) reported positive final results from its Alzheimer’s Biomarker Study to evaluate the potential of the company’s combination platform therapy for the treatment of AD. Preliminary results from the study, showed that TDP-43, a novel biomarker, was elevated in AD patients compared to a healthy control group. Based on these encouraging preliminary results, NeuroSense expanded the study with a larger healthy control group to further validate the results. NeuroSense's platform combination therapy technology has already shown a statistically significant reduction of TDP-43 in a Phase 2a clinical trial biomarker study in another neurodegenerative disease, amyotrophic lateral sclerosis (ALS), and is now being evaluated in a Phase 2b ALS double-blind clinical trial. Lastly, it was major news for Biogen Inc. (NASDAQ:BIIB) when the FDA accepted partner Eisai’s supplemental Biologics License Application (sBLA) for LEQEMB (lecanemab-irmb) 100 mg/mL injection for intravenous use, further supporting the conversion of LEQEMBI’s January 2023 accelerated approval into a traditional approval. As of mid-March 2023, the FDA had been planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting. The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. 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