Acumen Pharmaceuticals has presented positive topline results from an early-stage study of its investigational Alzheimer’s disease therapy at this year’s Alzheimer’s Association International Conference (AAIC). The drug, ACU193, works by targeting and binding to amyloid beta oligomers, a toxic and soluble version of the amyloid protein that forms brain plaques associated with Alzheimer’s disease. Results from the phase 1 randomised, placebo-controlled INTERCEPT-AD study of 62 patients with early Alzheimer’s disease showed the candidate was generally well tolerated throughout both single-ascending and multiple-ascending dose cohorts. Patients who received higher doses of the drug also showed a reduction in amyloid plaque after six to 12 weeks, the company said, adding that the study suggests the drug can be given as a monthly intravenous infusion. Commenting on the positive results, Acumen’s president and chief executive officer, Daniel O’Connell, said: “ACU193’s observed dose-related central target engagement, rapid reduction of ...
Alzheimer’s disease patients in the earliest stages of their disease benefited the most from Eli Lilly drug donanemab, which is expected to receive an FDA decision by the end of 2023. Full results from the drug’s pivotal study were presented during the during the Alzheimer’s Association International Conference. Eli Lilly has submitted its Alzheimer’s disease drug candidate for FDA review, and the pharmaceutical giant is now revealing a more complete look at the clinical data supporting an application that could make the therapy the second anti-amyloid antibody to win full regulatory approval. Lilly had previously said its drug, donanemab, led to a 35% slowing in the decline associated with Alzheimer’s. Those results were for patients with intermediate levels of tau, another protein that’s also characteristic of Alzheimer’s progression. In patients with low-to medium-levels of tau, representing an earlier stage of the disease, treatment with the Lilly drug led to a ...
Sales of the Alzheimer’s drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S. Wall Street is chewing over the Food and Drug Administration’s Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn’t a cure. Leqembi, from drugmakers Eisai and Biogen, is the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. Medicare on Thursday announced it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, broadening access for those who can’t afford the drug’s hefty $26,500-a-year price tag. But coverage comes with several conditions. Analysts believe certain Medicare requirements and new guidance on Leqembi’s prescription label could potentially weigh on sales of the ...
The US Food and Drug Administration (FDA) has granted traditional approval for Eisai and Biogen’s Leqembi (lecanemab-irmb) 100mg/mL injection to treat Alzheimer’s disease (AD) in adults. With the approval of the supplemental biologics licence application (sBLA), Leqembi becomes the first therapy to slow disease progression rate and cognitive and functional decline in AD patients. This development is based on findings from the Phase III portion of Eisai’s Clarity AD clinical trial. Trial data showed that the product met the Leqembi primary endpoint and all crucial secondary endpoints, and also demonstrated clinical benefit. In January 2023, the regulatory agency granted accelerated approval for Leqembi. Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and amyloid beta’s (Aβ) insoluble forms. Eisai CEO Haruo Naito stated: “The FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown ...
By Kristen Rogers, CNN Having a fluctuating cholesterol level has been linked with higher risk of Alzheimer’s disease, a new study has found. coldsnowstorm/iStockphoto/Getty Images Editor’s Note: Sign up for CNN’s Eat, But Better: Mediterranean Style. Our eight-part guide shows you a delicious expert-backed eating lifestyle that will boost your health for life. CNN — The fact that having high cholesterol can cause health problems is well known. But a total cholesterol level that fluctuates a lot — either up or down within a five-year period — might also be problematic by raising the risk of later dementia, a new study found. “This study adds to a growing body of evidence showing that addressing certain modifiable risk factors and promoting healthy behaviors can reduce the risk of cognitive decline, possibly reduce the risk of dementia, and protect cognitive health,” said Christopher Weber, director of global science initiatives at the ...
By David Adam Pictured: Person holding a cell phone in front of computer with stock data/iStock The release of positive topline results Thursday from the Phase III trial of BioXcel Therapeutics’ Alzheimer’s-related agitation treatment was overshadowed by disclosures to the SEC about fabricated email correspondences pertaining to the study’s safety data. In a Thursday SEC filing, BioXcel said that a trial site’s principal investigator—who enrolled 40% of the study participants at that site—was found to have fabricated email correspondences related to the timing of the filing for a serious adverse event (SAE) with the company’s vendor responsible for the monitoring of drug safety. The adverse event occurred in a subject in the placebo arm, the company said. In May 2023, it “came to the company’s attention that this same principal investigator in the TRANQUILITY II clinical trial may have fabricated email correspondence purporting to demonstrate that the investigator timely submitted ...
Companies will incorporate cells and technology to create a ‘clinical trial in a dish’ Axol Bioscience – a stem cell technology provider – has reached an agreement with StrataStem to access and commercialise its collection of Alzheimer’s disease (AD) patient samples. Under the terms, Axol will reprogramme the samples into ‘induced pluripotent stem cells’ (iPSCs) that can subsequently be separated into an extensive range of brain cells. These include neurons and neuroinflammatory cells. Formed in vitro, the cells can provide patient-specific human brain models from a cohort of AD patients, ultimately creating a ‘clinical trial in a dish’. The research concentrates on sporadic AD (sAD) – the most prevalent form of the disease, accounting for over 95% of all cases. sAD has no specific family link and is triggered by a combination of genetics, the environment and an individual’s lifestyle. Meanwhile, StrataStem’s collection of donor materials, including blood samples and ...
Two Democratic lawmakers are calling on Medicare to provide more information on how the program will make good on its promise to cover Alzheimer’s treatments for seniors. Rep. Anna Eshoo, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan said Medicare has failed to answer basic questions about how its coverage plan will work. The lawmakers told Chiquita Brooks-LaSure, who heads the Centers for Medicare and Medicaid Services (CMS), in a letter Monday that it is still “very unclear” how seniors will access the new treatments. Medicare has promised to cover Alzheimer’s antibody treatments on the same day the medications receive full approval by the Food and Drug Administration. The federal health program will cover the treatments through Part B of the program for seniors. Part B typically covers treatments that seniors can’t administer at home on their own, such as infusions. Under this policy, seniors ...
Medicare Part B will cover treatments for Alzheimer’s disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors. Anyone who has Medicare Part B and meets “eligibility criteria” will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday. Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions. The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline. But patients will have to participate in so-called registries that collect real-world data on how the drugs work. Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer’s antibody treatment. The FDA ...
By Rachel Cohrs CMS Administrator Chiquita Brooks-LasureCHIP SOMODEVILLA/GETTY IMAGES WASHINGTON — Despite pressure from Congress and advocates, Medicare isn’t changing its coverage plan for new Alzheimer’s drugs anytime soon. Medicare on Thursday issued a statement reiterating its intent to require patient registries to collect data about how medications perform even after they gain full Food and Drug Administration approval. Eisai’s Leqembi could gain full approval within the next month, so time is running short for the agency to solidify details. Right now, Leqembi and Biogen’s Aduhelm only have accelerated approval from the FDA, and are subject to even more restrictive coverage limits that require patients to be enrolled in a clinical trial to receive the medications. If Leqembi wins full approval, those restrictions will relax slightly, but providers would still need to collect data about all patients who receive the drugs in a patient registry. Medicare had previously announced ...
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