Alzheimer's disease Archives - Medical Design Sourcing

Beyond diabetes and obesity: Can GLP-1 therapies also transform chronic disease treatment?

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Glucagon-like peptide-1 (GLP-1) receptor agonists like semaglutide and tirzepatide have cemented their status as two of the most successful drugs in recent memory. Recent projections have estimated that the drug class could fetch $44 billion by 2030 and $71 billion by 2032.

But GLP-1 sales could potentially reach greater heights as these therapies move beyond their established territories of diabetes and obesity and start tackling major conditions like chronic liver and kidney disease, Alzheimer’s disease, and heart failure.

Promising clinical trial results highlight the potential of GLP-1s in an array of disease, including chronic kidney disease, nonalcoholic steatohepatitis (NASH), various forms of heart failure and potentially even Alzheimer’s.

There are, however, hurdles, such as a relatively high rate of gastrointestinal (GI) side effects, which affect somewhere around 40–7…

NKGen Biotech’s SNK01 ‘natural killer’ cell therapy for Alzheimer’s gets FDA nod for clinical trial

Santa Ana, California–based NKGen Biotech has received FDA clearance to begin a phase 1/2a trial for their “natural killer” cell therapy, SNK01, designed to treat Alzheimer’s Disease. The autologous, non-genetically modified natural killer (NK) cell therapy involves extracting a patient’s own cells through a blood draw, and then processing them to enhance their natural abilities in a laboratory setting before reinfusing them into the patient’s body.

NKGEN Biotech modifies NK cells to improve their cytotoxicity and their activating receptor expression, which helps them to identify and engage with target cells. This process imparts the NK cells with the ability to target and combat the specific cells associated with Alzheimer’s.

Early data are promising

Data from a phase 1, 3 + 3 dose-escalation trial found SNK01 to be well-tolerated. The drug candidate appeared to cross the blood-brain barrier to help reduce proteins and neuroinflam…

Phase 3 trial shows donanemab reduces Alzheimer’s symptoms by 35%

According to results from the Phase 3 TRAILBLAZER-ALZ 2 study published in JAMA, the monoclonal antibody donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease by approximately 35% at one year compared to placebo. The trial enrolled 1736 patients across 277 research centers in 8 countries.

Another monoclonal antibody, Leqembi (lecanemab) recently won FDA approval for Alzheimer’s disease treatment after showing a statistically significant 27% reduction in decline on the Clinical Dementia Rating Scale in trials.

Donanemab is an investigational plaque-clearing antibody similar to lecanemab and aducanumab, which controversially notched FDA approval in 2021 based on its plaque reduction despite inconsistent clinical efficacy data.

A look at TRAILBLAZER-ALZ 2

The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated that donanemab, an investigational drug, significantly slowed cognitive and fun…

Leqembi could mark new era in Alzheimer’s treatment progress: An overview of the evolving drug development scene

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Today, the FDA granted traditional approved to lecanemab (branded as Leqembi), a monoclonal antibody from Eisai and Biogen for adult patients with Alzheimer’s disease. The agency made the decision on the basis of a confirmatory trial that showed its clinical benefit.

The drug, which reduces the formation of amyloid plaques in the brain, is the first of its kind to transition from an accelerated approval to a traditional approval for Alzheimer’s treatment.

Leqembi’s annual launch price is $26,500.

Following approval, lecanemab stands to potentially gain Medicare coverage with qualifications.

The approval of Leqembi is a positive step forward and will spur further advances and investments in Alzheimer’s research, according to Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation (ADDF).

“We final…

Donanemab slows cognitive decline in early Alzheimer’s patients by 35%

Lilly’s (NYSE:LLY) shares were up more than 5.36% to $425.88 after the company announced upbeat results from the phase 3 TRAILBLAZER-ALZ 2 study, which revealed that the experimental Alzheimer’s drug donanemab significantly slowed cognitive decline in patients with early symptomatic Alzheimer’s disease at 18 months.

Almost half of patients, 47%, who received donanemab had no disease progression one year after treatment began, compared with 29% who did not receive the investigational antibody. Donanemab recipients had a clinical decline of 35% compared to placebo recipients based on the primary outcome measure. The drug group had 40% less decline in the ability to perform activities of daily living.

A potential blockbuster

Donanemab seems likely to win FDA approval given the positive data. In September 2022, UBS projected that donanemab would generate peak risk-adjusted sales of $4.8 billion. But earlier this year, FDA sent Lilly a complete response …

Lantheus acquires Cerveau and its imaging agent for Alzheimer’s

Lantheus (Nasdaq:LNTH) announced that it acquired Cerveau Technologies, a developer of a positron emission tomography imaging agent for detecting Alzheimer’s disease.

Cerveau develops the MK-6240 second-generation F 18-labeled PET imaging agent. It targets Tau tangles in Alzheimer’s disease.

Bedford, Massachusetts–based Lantheus intends to pay an upfront payment and potential development and commercial milestone payments. It also expects to pay double-digit royalty payments for research revenue and commercial sales.

Lantheus structured the deal as a stock purchase. The agreement specifies that, among other things, the seller will provide transition and clinical development services. These will be offered for a prescribed time following the closing of the transaction. Lantheus declined to disclose further terms of the deal.

“This exciting acquisition aligns with our growth strategy, further diversifying our radiopharmaceuti…

Building on recent progress in Alzheimer’s disease to achieve greater clinical benefit

Mouse model of Alzheimer’s disease [Image courtesy of NIH]

The recent announcement by Eisai/Biogen of the positive outcome of the CLARITY study of lecanemab — an antibody that preferentially targets soluble toxic beta-amyloid aggregates (protofibrils and oligomers) — supports the decades of research, overwhelming genetic data, and basic understanding that beta-amyloid is a bad actor in the Alzheimer’s disease process. It is also much-welcomed news for patients and their families who have long waited for a treatment that can slow this previously inexorable disease.

Cognition Therapeutics is pursuing a novel approach focusing on the same target – oligomeric amyloid beta. However, instead of attempting to remove amyloid from the brain, our oral small molecule (CT1812) is designed to modulate a key cellular receptor (sigma-2) that prevents oligomers from binding to neurons and thus blocks their synaptoto…

Fluoride nanoparticles could hold promise in treating Alzheimer’s

Beta amyloid plaques. [Image courtesy of NIH]

An international team of researchers has identified a technique that uses fluoride nanoparticles to potentially eliminate protein deformations. The method, which also can promote positive structural changes, could lead to the prevention and treatment of Alzheimer’s disease.

The scientists from Tokyo University of Science (TUS) in Japan and Nazarbayev University in Kazakhstan published the research in ACS Applied Bio Materials.

Noting the amyloid fibrils formed with the self-assembly of denatured proteins are associated with Alzheimer’s disease, the researchers discovered that fluoride nanoparticles could alter the assembly and structure of the amyloid β protein.

Fluoride nanoparticles are used in in vivo imaging, including brain imaging applications.

In particular, the scientists reported the influence of fluoride nanoparticles and surrounding io…

Biogen halts observational post-marketing study of aducanumab

Biogen (Nasdaq:BIIB) has terminated a study of the controversial Alzheimer’s disease drug Aduhelm (aducanumab) as a result of limited national policy for coverage.

In a listing on clinicaltrials.gov, the company notes that it anticipates there will limited prescriptions of the drug in routine clinical practice, which would provide limited enrollment for the planned ICARE AD study.

The study would have been a prospective, single-arm, multicenter study of aducanumab with up to 5 years of follow-up. The study would have collected data via routine visits every 6 to 12 months, but after opening up recruitment in November, only 29 volunteers had enrolled, according to data posted on clinicaltrials.gov.

Biogen and its partner Eisai (TYO:4523) announced their plans to launch the observational study in a presentation at the July 2021 Alzheimer’s Association International Conference. The drug had won FDA approval a month earlier.

Biogen still has a Phase 4 …

Athira Pharma to continue open-label Alzheimer’s extension studies

The biopharma Athira Pharma (Nasdaq: ATHA) has lengthened the current open-label extension (OLEX) study for its Phase 3 LIFT-AD and Phase 2 ACT-AD trials of fosgonimeton (ATH-1017, NDX-1017), hepatocyte growth factor receptor agonist, focused on mild-to-moderate Alzheimer’s disease.

The Bothell, Washington–based company made the decision based on feedback from its independent data and safety monitoring board.

ATHA shares fell about 3% to $8.89 in early afternoon trading.

Last October, the company’s former CEO, Leen Kawas, stepped down amidst research misconduct allegations, and Athira’s then-chief operating officer, Mark Litton, assumed the mantle of CEO.

In June 2021, the company announced they had put Kawas on leave. After the announcement, its stock dipped 39%.

In the recent news announcement, Athira said that participants in the LIFT-AD or ACT-AD studies could elect to join the open-label extension that provides up to …

IntelGenx doses first patient in Phase 2a Alzheimer’s study

IntelGenx Corp. (TSX:IGX/OTCQB:IGXT) has dosed the first patient in a resumed Phase 2a clinical trial involving an oral film of montelukast for Alzheimer’s disease (AD).

The COVID-19 pandemic previously interrupted the study for more than one year.

In 2019, the company initially announced that the study would enroll roughly 70 individuals with mild-to-moderate AD and test a montelukast buccal film.

The company issued a temporary recruitment hold in the second quarter of 2020 and resumed patient screening in October 2021.

Intelgenx produces oral, oral-topical and transmucosal films as well as transdermal patches.

Previously covered by U.S. Patent No. 5,565,473 that expired in 2012, montelukast (Singulair) from Merck & Co. first won FDA approval in 1998.

A 2017 article published in Open Neurology Journal found that the drug appeared to improve memory in a limited number of patients with cognitive impairment. In addition, …

EMA gives thumbs down to Biogen’s Alzheimer’s drug aducanumab

Biogen (NSDQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) have announced that the European Medicines Agency (EMA) has given its marketing authorization application for Aduhelm (aducanumab) a “negative trend vote.”

The Committee for Medicinal Products for Human Use (CHMP) with the EMA will likely adopt a formal opinion on the application during meetings scheduled for December 13-16.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Dr. Priya Singhal, head of global safety & regulatory sciences and interim head of R&D at Biogen, in a press release.

In the U.S., aducanumab has seen several setbacks in recent months.

In August, the Department of Veterans Affairs (VA) decided not to include aducanumab in its drug formulary. The VA…