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 …

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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…

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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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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…

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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, 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

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 …

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​​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 …

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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, …

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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…

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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 shares update on its ACT-AD and LIFT-AD studies of Alzheimer’s candidate ATH-1017

Athira Pharma (NSDQ:ATHA) announced that its lead development candidate, ATH-1017, had balanced baseline characteristics to date in two ongoing late-stage Alzheimer’s studies.

Presenting the data at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston, the company’s chief medical officer Dr. Hans Moebius said that the baseline characteristics are consistent between the ACT-AD and LIFT-AD studies.

Athira expects topline data from the ACT-AD to be available in the first half of 2022.

ACT-AD is a six-month double-blind Phase 2 trial while LIFT-AD is a six-month double-blind Phase 2/3 study.

ATH-1017 is a subcutaneously delivered small molecule drug that can cross the blood-brain barrier. The drug is designed to improve the activity of the hepatocyte growth factor (HGF) and its receptor, MET. The levels of both HGF and MET tend to be reduced in Alzheimer’s patients.

The company’s Aβ- and tau-…

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Roche’s amyloid-targeting gantenerumab wins breakthrough therapy designation for Azheimer’s 

Roche (OTCQX: RHHBY) has announced that its investigational anti-amyloid beta antibody gantenerumab for Alzheimer’s disease received breakthrough therapy designation from FDA. 

The agency has granted the status to a range of investigational Alzheimer’s, including lecanemab from Eisai and Biogen and donanemab from Eli Lilly. Biogen’s aducanumab had also received the designation before FDA approved it in June. 

Clinical trial data has shown that gantenerumab significantly reduced brain amyloid plaque, which accumulates in the brains of people with Alzheimer’s. 

The so-called amyloid hypothesis has led to the development of scores of failed experimental Alzheimer’s therapies. Biogen‘s (NSDQ:BIIB) aducanumab was the first to win FDA approval based on amyloid clearing.  

Showing convincing evidence of cognitive improvement, however, has remained more elusive for drug developers. A Phase 3 trial of gantenerumab did no…

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Report: Congressional committees have questions over Biogen’s Alzheimer’s drug

The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug.

According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by Sept. 16, having told the agency that the information “was helpful, but significant questions remain.”

Last month, the HHS Office of Inspector General said it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen and Eisai. FDA officials went on to defend the use of the accelerated approval pathway in correspondence in NEJM, arguing that amyloid reduction is a “reasonably likely” surrogate. 

The committees requested information regarding the …

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