Alzheimer's Pipeline of New Treatments Race to Improve Quality of Life for Patients

FinancialNewsMedia.com News Commentary

PALM BEACH, Fla., Oct. 20, 2022 /PRNewswire/ -- Last year, about 6.2 million people aged 65 and above living in America were suffering from Alzheimer's disease, (AD) which is estimated to increase to around 13.8 million by 2060. Women are more prone to be diagnosed with Alzheimer's disease than men due to the longer life expectancy of women. Moreover, Alzheimer's disease is becoming the most common cause of death in neurodegenerative diseases and a common cause of physical disability that require immediate treatment. A report from Grand View Research projected that the global Alzheimer's therapeutics market size was valued at USD 4.04 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 16.2% from 2022 to 2030. The rising prevalence of Alzheimer's disease and approval of disease-modifying therapies are expected to fuel market growth. The report indicated that new product launches and R&D investments are some of the key strategies adopted by the key players to acquire a greater market share. The report said: "The pipeline drugs segment is expected to witness the fastest growth over the forecast period owing to the impending launch of multiple disease-modifying therapies (these) drug candidates under development that will modify the treatment landscape of AD. According to Alzheimer's Association, there were 143 drug candidates in 172 clinical trials for AD. Of these, 31 drug candidates in phase 3 clinical trial, 82 drug candidates in phase 2, and 30 drug candidates in phase 1. Successful completion of trials and subsequent approval of these products are anticipated to boost the market growth."  Silo Pharma, Inc. (NASDAQ: SILO), Biogen Inc. (NASDAQ: BIIB), Cassava Sciences, Inc. (NASDAQ: SAVA), Prothena Corporation plc (NASDAQ: PRTA), Anavex Life Sciences Corp. (NASDAQ: AVXL).

Grand View continued: "The hospital pharmacy segment dominated the market in 2021 with a revenue share of over 55.0% owing to the increasing hospitalization due to a rise in the geriatric population and Alzheimer's patients. According to Alzheimer's Association report 2022, there are 518 hospitalizations per 1,000 Medicare beneficiaries in the geriatric population having Alzheimer's or other dementias as compared to only 234 hospitalizations per 1,000 Medicare beneficiaries without these conditions. The e-commerce segment is expected to expand at a CAGR of 15.33% over the forecast period. An increase in the usage of the internet and smartphone, ease of ordering medications through an e-commerce platform, and increasing e-commerce services globally are expected to fuel the segment growth in the coming years."

Silo Pharma, Inc. (NASDAQ: SILO) BREAKING NEWS: Silo Pharma Announces Data Supporting Therapeutic Potential of SPC-14 for Alzheimer's Disease in Pre-Clinical Study - Dosing study of SPC-14 demonstrates efficacy for increasing memory function -- Silo Pharma, Inc. (NASDAQ: SILO) ("the Company"), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced proof-of-concept data supporting the therapeutic potential of SPC-14 as a treatment for Alzheimer's disease (AD), as demonstrated in a mouse model. The research was conducted as part of a sponsored research agreement with Columbia University in New York.

SPC-14, a novel drug that combines an FDA-approved therapeutic with ketamine, is in development for the treatment of dementia related to Alzheimer's disease. Initial data from its SPC-14 research studies shows that chronic dosing of SPC-14 resulted in increased memory in AD mice and had no negative weight effects on the subjects. 

"The result from these studies is a first step in the development of SPC-14 as a potential therapeutic for the treatment of Alzheimer's," said Eric Weisblum Chief Executive Officer of Silo Pharma. "SPC-14 is a therapeutic that utilizes ketamine as one part of the formulation. With safety data already available from the approved therapeutic in the compound, we believe SPC-14 should be eligible for development under the FDA's 505(b)(2) regulatory pathway. This will allow Silo Pharma to reach efficacy clinical trials faster and save costs in potentially bringing to market a potential novel new treatment for Alzheimer's patients."

"On-going research studies are currently being conducted by Silo and we look forward to sharing these results as additional data becomes available," Weisblum added. 

Silo Pharma's Commercial Evaluation License Agreement (CELA) with Columbia University grants an option to license two distinct assets currently under development: SPC-14 targeting Alzheimer's disease and SPC-15 targeting stress-induced affective disorders. CONTINUED… Read this full release for Silo Pharma at: https://www.financialnewsmedia.com/news-silo/ 

Other recent developments in the markets include:

Eisai Co., Ltd. and Biogen Inc. (NASDAQ: BIIB) recently announced positive topline results from Eisai's large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab (development code: BAN2401), 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. Lecanemab met the primary endpoint (CDR-SB: Clinical Dementia Rating-Sum of Boxes*) and all key secondary endpoints with highly statistically significant results. Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai's FY2022, which ends March 31, 2023.

Additionally, Eisai will present the Clarity AD study results on November 29, 2022, at the Clinical Trials on Alzheimer's Congress (CTAD), and publish the findings in a peer-reviewed medical journal.

CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia. Based on interviews of people living with AD and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and CDR-SB is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of AD.

Cassava Sciences, Inc. (NASDAQ: SAVA), a clinical-stage biotechnology company focused on Alzheimer's disease, recently announced the initiation of an open-label extension study. This study is designed to provide no-cost access to simufilam, an investigational drug, to patients with Alzheimer's disease who complete either one of Cassava Sciences' on-going Phase 3 studies, which are double-blind, placebo-controlled trials.

"We believe this open-label study is the right thing to do," said Remi Barbier, President & CEO. "Alzheimer's patients who complete one of our Phase 3 studies are eligible to enroll, knowing there is no placebo and no blinding in our open-label extension study."

Prothena Corporation plc (NASDAQ: PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, recently reported financial results and provided business highlights for the second quarter and first six months of 2022.

"We are closing the first half of 2022 from a position of strength, with multiple clinical programs advancing and a solid cash position supporting a robust set of milestones anticipated in 2022 and beyond. We are grateful for the opportunity to quickly progress the development of PRX012, a next-generation anti-Aβ antibody, under FDA's Fast Track designation, further reinforcing our commitment to Alzheimer's disease patients and their families," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "We believe our anticipated progress in the second half of the year will continue to validate our biology-directed R&D strategy, with antibodies that have been engineered to target pathogenic proteins in a manner we believe will be most impactful for the treatment of disease. We expect to achieve multiple milestones, including topline Phase 1 data for PRX005, the initiation of a Phase 1 multiple ascending dose study of PRX012 and the continued advancement of the Phase 2 study of PRX004 by Novo Nordisk. Additionally, we remain focused on our confirmatory Phase 3 AFFIRM-AL study of birtamimab, the first potential therapy to show survival benefit in Mayo Stage IV patients with AL amyloidosis."

Anavex Life Sciences Corp. (NASDAQ: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) disorders, recently announced that the company will present Phase 2b/3 ANAVEX®2-73-AD-004 data of oral ANAVEX®2-73 (blarcamesine) for Early Alzheimer's Disease at the upcoming Clinical Trials on Alzheimer's Disease (CTAD) Congress 2022 in San Francisco, CA and publish the findings in a peer-reviewed medical journal.

Alzheimer's disease is the most common cause of dementia and the fifth leading cause of death in adults older than 65 years. The estimated total healthcare costs for the treatment of Alzheimer's disease in 2020 were estimated at $305 billion, with the cost expected to increase to more than $1 trillion as the population ages. Most of the direct costs of care for Alzheimer's disease are attributed to skilled nursing care, home healthcare, and hospice care. Indirect costs of care, including quality of life and informal caregiving, are likely underestimated, and are associated with significant negative societal and personal burdens.

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