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…

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Athira Pharma stock tanks after announcing results from Phase 2 Alzheimer’s study

The neurodegeneration-focused biopharma Athira Pharma (Nasdaq:ATHA) has seen its stock drop more than 90% since December 31, 2020. Today alone, the company’s share price was down 66.73%, falling to $2.81, in mid-day trading after the company announced disappointing results from the Phase 2 ACT-AD study focused on fosgonimeton in Alzheimer’s disease.

The company announced that the study failed to meet its primary endpoint, which involved a statistically significant change in event-related potential (ERP) P300 latency.

P300 is a measure of decision-making detected using electroencephalography (EEG).

Athira did note the suggestion of a positive effect in a pre-specified subgroup analysis in ERP P300 latency and Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at week 26 relative to placebo.

“Following compelling ERP P300 latency biomarker data from a small Phase 1b trial over eight days in Alzheimer’s…

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Nine out of ten U.S. neurologists have Aduhelm efficacy doubts

A recent physician survey found that 89% of neurologists in the U.S. have concerns about the efficacy of the controversial Alzheimer’s drug Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and Eisai Co. (TYO:4523). Nearly as many — 87% — were concerned about the drug’s safety profile.

The survey from the physician social media network Sermo (New York City) asked more than 50 neurologists about their view of the drug, which has failed to find widespread use, generating just $3 million in 2021. Only 11% of the neurologists surveyed reported prescribing the drug.

Despite low uptake, many patients are aware of the drug. A total of 62% of the surveyed neurologists reported that at least one patient had asked them about Aduhelm.

The drug has faced an array of challenges since it was FDA-approved in June 2021. Recently, Medicare decided to limit Aduhelm’s coverage of the drug to clinical trial participants, and other payers, including the Department of Veteran Af…

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Alzheimer’s group files FOIA request related to CMS decision on amyloid-targeting antibodies 

UsAgainstAlzheimer’s, a nonprofit organization committed to stopping Alzheimer’s disease, is hoping to get more information related to CMS’s national coverage determination related to coverage for Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and other monoclonal antibodies targeting amyloid to treat Alzheimer’s disease.

The organization has filed a Freedom of Information Act (FOIA) request for information about the decision.

UsAgainstAlzheimer’s is seeking information describing the potentially harmful impact of refusing to cover such monoclonal antibodies outside of clinical trials.

CMS announced their national coverage determination for Aduhelm and other similar future monoclonal antibodies last week.

UsAgainstAlzheimer’s concluded that CMS has denied access to millions of people in the U.S. living with Alzheimer’s.

“The National Coverage Determination is historic – and not in a good way. CMS has covered every FDA-approved drug, but now…

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CMS will limit coverage of Aduhelm to people in clinical trials

The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab).

Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval and, about a week later, nonprofit watchdog group Public Citizen called for high-profile resignations for FDA officials as a result of the approval.

In August 2021, the HHS Office of Inspector General announced that it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug.

Get the full story at our sister site, Pharmaceutical Processing World.

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CMS will limit coverage of Aduhelm to people in clinical trials

The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab).

Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval and, about a week later, nonprofit watchdog group Public Citizen called for high-profile resignations for FDA officials as a result of the approval.

In August 2021, the HHS Office of Inspector General announced that it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug.

Yesterday’s CMS policy stated that Aduhelm and any future monoclonal antibodies directed against amyloid approved by the FDA will be covered by Medicare under coverage with evidence development (CED). CMS will, as part of the decision, provide enhanced acces…

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Scientists find new potential drug targets for neurodegenerative diseases

Maria Clara “Maca” Franco, center, with Kyle Nguyen, left, and Lydia Bastian. Franco’s research investigates neurodegenerative diseases. Image courtesy of Oregon State University.

Researchers at Oregon State University (OSU) have discovered a new class of potential drug targets for diseases like Alzheimer’s, Parkinson’s and amyotrophic lateral sclerosis (ALS).

The scientists are working to identify the best method to attack the targets — oxidized proteins. The most potent oxidant of the bunch is peroxynitrite, which is produced in conditions involving inflammation. Oxidized proteins and free radicals can damage DNA, lipids and proteins implicated in neurodegenerative diseases and other conditions.

Peroxynitrite is produced thanks to the diffusion-limited reaction of nitric oxide and superoxide.

Peroxynitrite appears to be especially pernicious when it oxidizes heat shock prote…

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U.S. insurers hesitant to cover aducanumab

Health insurers in the U.S. are seeking more data from Biogen regarding its $56,000-per-year Alzheimer’s treatment Aduhelm (aducanumab) before agreeing to pay for the treatment, according to Bloomberg. None of the 25 large insurers that took part in a Bloomberg News survey found that the drug was “medically necessary.”

Humana Inc. is, however, covering Aduhelm for patients who are similar to those in the drug’s clinical trials.

Having won conditional FDA approval in June, aducanumab has failed to gain traction as a popular therapy.

Biogen developed the drug in collaboration with Eisai Co., Ltd. (Tokyo, Japan).

The drug has received a flurry of negative headlines in recent months.

FDA called for an OIG investigation into its own dealings when reviewing the drug, and two House committees have launched investigations into its approval as well.

This week, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHM…

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MoCA offers certification on cognitive assessment for early Alzheimer’s detection

Online training and certification is available for the 30-question Montreal Cognitive Assessment (MoCA) used to detect the earliest stages of Alzheimer’s and other cognitive disorders.

“Our goal has always been to offer the most advanced screening tools for the earliest detection of cognitive disorders,” MoCA test inventor and neurologist Dr. Ziad Nasreddine said in a news release. “Research has shown additional training to be helpful in reducing common administration errors and improving standardization, which limits risks for clinicians and patients, and improves quality of care.”

The test, which usually takes about 10 minutes to complete, is available in paper and digital formats and is widely used in clinical, research, and senior care settings across the globe. MoCA said more than 500 peer-reviewed studies have shown its test to be more sensitive and accurate than other commonly used assessments, including the Mini-Mental Stat…

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Athira Pharma CEO steps down in the wake of research misconduct allegations

Athira Pharma (NSDQ:ATHA) saw its stock jump 9.35% in mid-day trading after the company announced that its embattled CEO Leen Kawas was resigning.

Kawas will also give up her seat on the Bothell, Washington–based company’s board.

Facing allegations that she had doctored a series of images in research papers, Leen Kawas was placed on leave in June.

Several papers she co-authored at the Journal of Pharmacology and Experimental Therapeutics received expressions of concern regarding the possibility of manipulated images.

Mark J. Litton

An internal investigation recently concluded that Kawas had doctored images in several research papers she authored or co-authored while at Washington State University. Kawas received a Ph.D. from the university in molecular pharmacology in 2011.

Mark Litton will assume the CEO mantle of Athira. Litton was the company’s former chief operating officer an…

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Cassava Sciences reveals top-line results from Alzheimer’s trial interim analysis 

Cassava Sciences (NSDQ:SAVA) announced that its experimental Alzheimer’s drug simufilam was associated with an improved cognition score at 12 months. Specifically, recipients of the drug showed a 3.2 point improvement on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) from baseline to month 12.

Austin, Texas–based Cassava also announced that 68% of study participants demonstrated improved ADAS-Cog scores at 12 months. Among participants with improvement, the average increase in ADAS-Cog score was 6.8 points.

The data came from a pre-planned interim analysis of an open-label study.

“We look forward to the initiation of a randomized, double-blind, placebo-controlled pivotal Phase 3 clinical program with simufilam in people with Alzheimer’s disease,” said Remi Barbier, the company’s CEO, in a statement.

Investors were apparently unimpressed, sending SAVA shares down 1.04% apiece to $52.31. Sh…

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Could COVID-19 vaccines guard against dementia?

COVID-19 vaccines could potentially guard against dementia and Alzheimer’s disease, according to an op-ed in WSJ. 

COVID-19 infection itself can lead to long-term cognitive decline in some individuals and can accelerate Alzheimer’s symptoms, concluded an Alzheimer’s Association study. An Alzheimer’s Research & Therapy echoed those findings. 

Pointing to data suggesting that vaccinations against tetanus and flu lead to reduced Alzheimer’s incidence in seniors, the WSJ article notes that a systemic immune response from vaccines could lower brain inflammation and thus protect brain neurons. 

The thesis is not new. For example, a 2001 study in the Canadian Medical Association Journal theorized that prior vaccination against diphtheria or tetanus, poliomyelitis and influenza could protect against Alzheimer’s disease.

And last July, the Alzheimer’s Association published a study making similar claims. Researchers have correlated flu and pneumonia vac…

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