R&D Efforts for Alzheimer's Therapies on the Rise with over 120 Drugs in Development

PALM BEACH, Fla., March 31, 2022 /PRNewswire/ -- FinancialNewsMedia.com News Commentary - Alzheimer's disease (AD) is an irreversible, progressive neurodegenerative disease. It is the most common cause of dementia among the elderly, accounting for between 60% and 80% of cases in the US, Japan and five major EU markets (the UK, Germany, France, Italy, and Spain). According to Alzheimer's Association, in 2018, an estimated 5.7 million people in the United States who are aged 65 or older are living with AD. By 2050, this number is predicted to increase to approximately 14 million.  According to the World Health Organization, an estimated 50 million people worldwide currently have dementia, and there are nearly 10 million new cases every year; Alzheimer disease affects about 60-70% of them.  Alzheimer's disease is the sixth-leading cause of death in the United States, and the fifth-leading cause of death among those age 65 and older. It also is a leading cause of disability and poor health. There are a large number of patients at the earliest stages of disease, before the onset of dementia, currently undiagnosed and untreated (prodromal disease).  A report from iHealthcareAnalyst projected that the global market for Alzheimer's disease is expected to attain $25 billion by 2027, growing at a staggering CAGR of 17.5% over the forecast period, driven by rapidly ageing population, increasing prevalence of AD, coupled with technological advancements in diagnostics and biomarkers.    Active Companies in the markets today include Longeveron Inc. (NASDAQ: LGVN), Mesoblast Limited (NASDAQ: MESO), Cassava Sciences, Inc. (NASDAQ: SAVA), Denali Therapeutics Inc. (NASDAQ: DNLI), Alector, Inc. (NASDAQ: ALEC).

The report said: "As drug development shifts toward these prodromal patients, likely with premium-priced biological therapies, the market will expand considerably. There are no drug treatments that can cure Alzheimer's disease or any other common type of dementia. There is a substantial opportunity for pharma companies to drive an increase in the wider Alzheimer's market by improving diagnostic capabilities. The number of drug candidates in development for Alzheimer's is at its highest-ever level.  Despite the lack of success to date, biopharma companies continue to believe the potential rewards are worth the risk. As R&D in the field accelerates, therapies that treat not only symptoms of the disease but also slow its progression are expected to arrive much earlier.  With 10,000 baby boomers turning 65 every day in the US, the market opportunity for AD and other neurodegenerative disorders represents a large and growing area. New approaches are emerging, with over 120 AD drugs in development, targeting multiple pathways."

Longeveron Inc. (NASDAQ: LGVN) BREAKING NEWS:  Longeveron publishes Peer Reviewed Study of Phase 1 Trial Results of Lomecel-B for Alzheimer's Disease in Alzheimer's & Dementia©: The Journal of the Alzheimer's Association - Longeveron Inc. ("Longeveron" or "Company"), a clinical-stage biopharma company developing cellular therapies for aging-related illnesses, chronic disorders, and other specific life-threatening conditions, announced the publication of results from a Phase 1 trial testing Lomecel-B on patients with mild Alzheimer's disease (AD) in Alzheimer's & Dementia® : The Journal of the Alzheimer's Association. The trial met its primary endpoint, demonstrating that Lomecel-B was well tolerated in this patient population. In addition, the data provided indications supporting further exploration of Lomecel-B, particularly the therapeutic potential to slow cognitive decline and improve quality of life in patients with AD.

"We are pleased and encouraged by the publication of our study in this high-impact journal," said Geoff Green, CEO of Longeveron. "The Lomecel-B study was funded by two competitive Part the Cloud Neuroinflammation Challenge grants awarded to Longeveron from the Alzheimer's Association, for which we are extremely grateful."

The article, titled "Results and Insights from a Phase 1 Clinical Trial of Lomecel-B for Alzheimer's disease," details the study findings on Longeveron's lead investigational product, Lomecel-B, an allogeneic bone marrow-derived medicinal signaling cell (MSC) product, given to patients with mild Alzheimer's disease.

"What makes this study unique is the use of a cellular therapy that may potentially target multiple pathological features of Alzheimer's disease simultaneously," said Dr. Mark Brody, lead author of the manuscript. "Not only did the study meet its primary endpoint of safety, but it also suggests the potential that Lomecel-B could have in treating patients with Alzheimer's disease.  We found data suggesting that Lomecel-B could have effects ranging from increasing blood vessel health to reducing inflammation, which could yield promising results."

The double-blinded, randomized, placebo-controlled trial was conducted on thirty-three patients at four clinical sites. Each patient received a single intravenous infusion of low- or high-dose Lomecel-B, or a placebo. The findings from this study are being tested in a new larger Phase 2 study, which commenced in December 2021, and has already treated the first patient and continues to enroll others. The new trial is double-blinded, randomized, and placebo-controlled, and is designed to evaluate single versus multiple doses of Lomecel-B for mild Alzheimer's disease.   CONTINUED…  For more information about Longeveron, please visit https://investors.longeveron.com/news/default.aspx 

Other recent developments in markets include:

Mesoblast Limited (NASDAQ: MESO), global leader in allogeneic cellular medicines for inflammatory diseases, recently announced positive results from an interim analysis of the first patient cohort in the randomized, controlled study of remestemcel-L by direct endoscopic delivery to areas of inflammation in patients with medically refractory ulcerative colitis or Crohn's colitis. A single local delivery of remestemcel-L by colonoscopy resulted in rapid mucosal healing and disease remission in these refractory patients at high risk of progression to surgery.

The results of the first cohort of patients were presented at the 17^th Congress of European Crohn's and Colitis Organisation (ECCO), February 16-19, by the trial's lead investigator Dr. Amy L. Lightner, Associate Professor of Surgery in the Department of Colon and Rectal Surgery at Cleveland Clinic and were published in the Journal of Crohn's and Colitis.

Cassava Sciences, Inc. (NASDAQ: SAVA), a clinical-stage biotechnology company focused on Alzheimer's disease, recently announced financial results for the year ended December 31, 2021 and provided clinical and business updates.

"In second half 2021, we initiated two separate Phase 3 clinical studies with our lead drug candidate, simufilam, in patients with Alzheimer's disease," said Remi Barbier, President & CEO. "This was a large, complex endeavor. We deeply appreciate every member of the team inside and outside the Company who contributed to this effort. Our challenge for 2022 and beyond is to enroll over 1,700 patients into our Phase 3 clinical program. With this evolution, we intend to prove once again that we are a small company capable of doing big things."

Cassava Sciences' Phase 3 studies are now recruiting patients with mild to moderate Alzheimer's disease. Drug has been shipped to nearly 100 clinical trial sites across North America, with additional sites planned in the U.S. and overseas. Over 200 patients have been screened to date.

Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, recently announced that dosing has begun in a Phase 1/2 clinical trial of DNL593 (PTV:PGRN) for the potential treatment of frontotemporal dementia (FTD) caused by mutations in the granulin gene (GRN). Pending initial clinical data from the Phase 1 healthy volunteer portion of the clinical trial, Denali expects to begin dosing individuals with FTD-GRN in the second half of 2022. Denali and Takeda have a strategic collaboration to co-develop and co-commercialize DNL593.

FTD-GRN is characterized by progranulin (PGRN) deficiency in the brain. DNL593 is an investigational brain-penetrant, recombinant PGRN replacement therapy enabled by Denali's Protein Transport Vehicle (PTV:PGRN). The therapeutic goal of DNL593 is to slow or prevent progression of FTD-GRN by increasing intracellular and extracellular levels of functional PGRN.

Alector, Inc. (NASDAQ: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, recently presented results from the INFRONT-2 Phase 2 clinical trial of AL001 (latozinemab) in frontotemporal dementia patients (FTD) with a C9orf72 genetic mutation (FTD-C9orf72) at the AD/PD™ 2022 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders taking place virtually and in person in Barcelona, Spain. Latozinemab is a potential first-in-class monoclonal antibody designed to elevate progranulin, a key regulator of immune activity and lysosomal health in the brain. FTD is a rare and rapidly progressing neurodegenerative disease that is the most common form of dementia for people under the age of 60.

In 2021, Alector presented results showing that latozinemab elevated progranulin levels in a cohort of symptomatic carriers of the progranulin mutation causative of FTD (FTD-GRN) patients for the duration of treatment, and as compared to matched controls, showed associated changes in exploratory biomarkers and a trend toward a delay in annual disease progression. Today's data from the FTD-C9orf72cohort build upon the results observed in the Company's studies to date in FTD-GRN patients.

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