The development of therapies for Alzheimer’s disease has always caused many developers to feel exhausted, and now AbbVie has also increased its investment in neurodegenerative diseases. AbbVie has agreed to spend $1.4 billion to acquire Aliada Therapeutics, whose main acquisition asset is Aliada’s authorized Alzheimer’s disease candidate drug ALIA-1758 from Johnson&Johnson. Its mechanism of action is still an anti beta amyloid protein (3pE-A β) antibody, but the unique feature of ALIA-1758 is that it can cross the blood-brain barrier, greatly improving the brain’s absorption rate. Aliada started a phase 1 trial among healthy volunteers in May, but AbbVie believes the timing is ripe for acquisition. Previously, AbbVie made the decision to abandon its internal Alzheimer’s disease asset ABBV-916. This anti beta amyloid antibody has no significant difference in safety and efficacy compared to the already marketed monoclonal antibody therapy for Alzheimer’s disease. Therefore, AbbVie decided to terminate the development ...
On September 25, NMPA released information on the delivery of drug certification documents, and the rivastigmine transdermal patch of Beijing Taide Pharmaceutical Co., Ltd. (hereinafter referred to as “Tide Pharmaceutical”), a subsidiary of Sino Biopharmaceutical, was approved for marketing. It is understood that the drug can be used to treat mild to moderate Alzheimer’s disease. Forecasts of the development trend of Alzheimer’s disease and other forms of dementia in China show that in 2030, 2040 and 2050, the number of AD patients in the population aged 60 and above in China will reach 19.11 million, 24.71 million and 27.65 million respectively. Under the influence of multiple factors such as the accelerated aging trend of the population in China and the increasing prevalence of major cardiovascular diseases and related factors, the prevalence and number of patients with Alzheimer’s disease have also shown an increasing trend year by year. Rivastigmine is an ...
Alzheimer’s disease impacts one in five women and one in ten men over their lifetimes, yet diagnostic tools are still often cumbersome and not widely accessible in primary care settings. Although specialized memory clinics frequently use advanced diagnostic methods like PET scans and cerebrospinal fluid tests, there is a significant need for simpler, quicker diagnostic tools that can be used in primary care. Now, a commercially available blood test for Alzheimer’s has demonstrated approximately 90% reliability in primary care settings, representing a major development for individuals seeking assistance for memory loss and suspected of having this neurological disease. Research on this innovative blood testing method, which evaluates levels of Plasma Phospho-Tau217, commenced in 2019 with studies showing that the blood test can detect Alzheimer ‘s-related changes even before symptoms appear and monitor the disease’s progression. Earlier this year, results indicated that this blood test is as reliable as, and ...
July 29, 2024 By Don Tracy, Associate Editor Approval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve tolerability and efficacy in treating Alzheimer disease, company says.The FDA has approved Alpha Cognition’s Zunveyl (benzgalantamine), an oral therapy for treating mild-to-moderate Alzheimer disease (AD). According to the company, the approval marks a significant advancement in the treatment of AD by offering a novel approach with a dual mechanism of action designed to improve tolerability and efficacy. Zunveyl is a prodrug of galantamine, an acetylcholinesterase inhibitor (AChEI), that works by preventing the breakdown of acetylcholine, a crucial neurotransmitter involved in memory and attention. Alpha Cognition stated that Zunveyl functions as an allosteric potentiator, enhancing the release of acetylcholine from presynaptic neurons.1 “I am very excited about the approval of Zunveyl, which we believe offers better tolerability for patients with Alzheimer’s disease. We have always believed in ...
Novo Holdings led Asceneuron’s $100 million Series C financing. The Merck Serono spinout’s lead program is an oral small molecule designed to prevent aggregation of tau protein in neurodegenerative disorders. By Frank Vinluan Alzheimer’s disease patients can now choose between new two intravenously infused therapies that work by breaking up plaques of amyloid protein in the brain. Asceneuron takes a different approach with oral therapies that address the buildup of tau, a protein that’s also associated with the neurodegenerative disorder. The biotech now has $100 million to advance its lead program to Phase 2 testing. The Series C financing announced Tuesday was led by Novo Holdings, the company that manages the assets of the Novo Nordisk Foundation, the controlling shareholder of metabolic drug giant Novo Nordisk. Using a drug to target and break up pathological proteins associated with Alzheimer’s has been validated by Eisai’s Leqembi, approved by the FDA last year, ...
The U.S. Food and Drug Administration has approved Eli Lilly’s Kisunla (donanemab-azbt) injection, a new treatment for Alzheimer’s disease. Targeted at adults in the mild cognitive impairment or mild dementia stage, Kisunla has shown significant promise in slowing clinical decline, offering a new beacon of hope for patients and their families. The approval comes after a double-blind, placebo-controlled, parallel-group study (Study 1, NCT04437511) in patients with Alzheimer’s disease. The patients had confirmed the presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease. 1736 patients were randomised 1:1 to receive 700 mg Kisunla every four weeks for the first 3 doses, and then 1400 mg every four weeks (N = 860) or placebo (N = 876) for a total of up to 72 weeks. The treatment was switched to placebo based on a prespecified reduction in amyloid levels measured by positron emission tomography (PET) at Week ...
By Don Tracy, Associate Editor Kisnula is the first amyloid plaque-targeting therapy that allows for stopping treatment upon plaque removal, company says. The FDA has approved Eli Lilly’s Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion) to treat adults with early symptomatic Alzheimer’s disease, including mild cognitive impairment and mild dementia with confirmed amyloid pathology. According to the company, Kisunla the first amyloid plaque-targeting therapy that allows for stopping treatment upon plaque removal, potentially reducing costs and infusion frequency. Approval was based on results from the Phase III TRAILBLAZER-ALZ 2 study.1 “Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis,” said Anne White, EVP, president, Lilly Neuroscience, Eli ...
Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy. By Frank VinluanEli Lilly Alzheimer’s disease drug has received its long-awaited FDA approval, bringing patients a treatment that works similarly to an Eisai medication for the neurodegenerative disorder but with dosing advantages that patients might prefer. The Tuesday regulatory decision comes less than a month after an FDA advisory committee voted unanimously that the benefits of the Lilly drug in slowing cognitive decline outweigh its safety risks. The approval covers the treatment of Alzheimer’s patients with mild cognitive impairment or mild dementia, the same population that was evaluated in clinical trials. Known in development as donanemab, Lilly will market its new Alzheimer’s ...
Don Tracy, Associate Editor Investment from the Alzheimer’s Drug Discovery Foundation (ADDF) aims to support the development of Coya 302, a therapeutic candidate for the treatment of frontotemporal dementia (FTD). Coya Therapeutics announced that it has received a $5 million strategic investment from the Alzheimer’s Drug Discovery Foundation (ADDF). According to the company, the investment consisted of 603,136 shares of stock at $8.29 per share. Coya intends to use the funding for supporting the development of Coya 302, its lead therapeutic candidate, mainly in an upcoming Phase II trial targeting frontotemporal dementia (FTD). Reportedly, the investment was made through a private placement under Section 4(a)(2) of the Securities Act of 1933 and Regulation D, aiming to file a registration statement with the SEC for resale of the securities.1 “We are grateful that a world-renowned organization like the ADDF has chosen to support our corporate mission as well as the clinical ...
Alzheimer’s disease is well known for its slow development over many years, which typically leads to treatment interventions only after the disease has advanced to stages where it may be nearly impossible to slow down its progression. The results of a groundbreaking study, recently published in the journal Nature Communications, have offered new hope for not only earlier diagnosis but also for potentially slowing the course of Alzheimer’s disease. A team of researchers from Aarhus University (Aarhus, Denmark) has identified a specific receptor found on immune cells that can bind and neutralize harmful “beta proteins”, which are closely linked with the development of Alzheimer’s disease. The study underscores the significant role that the peripheral immune system may play in defending the body against Alzheimer’s by preventing the build-up of these harmful proteins in the brain. This discovery paves the way for detecting the disease-related changes much earlier than current methodologies ...
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