Cambridge, Massachusetts. The race to stem the progression of Alzheimer’s comes as millions of people around the world are living with the disease. According to Alzheimer’s International, by 2050, 139 million people will be living with Alzheimer’s globally, if there is no effective treatment. This may change with the latest announcement of a promising new drug trial.
Top line drug research findings
Michel Vounatsos CEO of Biogen announced the topline results of an Alzheimer’s drug trial on the 27th of September 2022 in the US. The findings came from Eisaiβs large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab.Β
By all accounts, the experimental Alzheimer’s drug has significantly slowed cognitive and functional decline in a large trial of patients in the early stages of the disease. Media reports confirm that the findings represent an importantΒ breakthrough in a field littered with failed drugs.
Michel Vounatsos CEO of Biogen announces drug trial results.
What success will mean
βTodayβs announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimerβs disease, and provide a clinically meaningful impact on cognition and function,βΒ reports Vounatsos.
βImportantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease.β
Alzheimer’s drug slows the progress of the brain-wasting disease by 27%
According to Vounatsos, βThis is an investigational anti-amyloid beta (AΞ²) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimerβs disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.β
The Biogen announcement said lecanemab met the primary endpoint (CDR-SB: Clinical Dementia Rating-Sum of Boxes*) and all key secondary endpoints with highly statistically significant results.
The drug, lecanemab, slowed progress of the brain-wasting disease by 27% compared with a placebo, meeting the study’s main goal, and potentially offering hope for patients and their families desperate for an effective treatment.
A drug to defeat Alzheimer’s
Biogen are considered pioneers in neuroscience. Vounatsos believes defeating Alzheimer’s will require multiple approaches and treatment options.
βWe look forward to continuing the discussion about the significance of these findings with the patient, scientific, and medical communities.β
The announcement was shared by leading media worldwide, confirming the importance of the drug breakthrough.
According to a Reuters report, βEisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisaiβs FY2022, which ends March 31, 2023. β
Drug results to be presented at the Clinical Trials on Alzheimerβs Congress CTAD
Eisai will present the Clarity AD study results on November 29, 2022, at the Clinical Trials on Alzheimerβs Congress (CTAD), and will publish the findings in a peer-reviewed medical journal.
An important milestone in the Alzheimerβs disease community
“The positive result of the lecanemab, an anti-AΞ² protofibril antibody, pivotal study after almost 25 years since Ariceptβs launch is also an important milestone for Eisai in fulfilling the companies mission to meet the expectations of the Alzheimerβs disease community.”
Alzheimerβs disease not only presents a great challenge for patients and their families. It also negatively impacts society, including decreased productivity, increased social costs, and disease-related anxiety.Β
“We believe that helping to alleviate these burdens will positively impact society as a whole,β echoed Haruo Naito, Chief Executive Officer at Eisai.Β
Haruo Naito, Chief Executive Officer at Eisai shares thoughts on drug trial results.Β Photo credit: Esai.com
He added, βAdditionally, the lecanemab Clarity AD study results prove the amyloid hypothesis, in which the abnormal accumulation of AΞ² in the brain is one of the main causes of Alzheimerβs disease when targeted with a protofibril-binding therapy.”
Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimerβs disease as well as further activate innovation for new treatment options.Β
FDA update
Biogen’s press statement shared, βIn July 2022, the U.S. Food and Drug Administration (FDA) accepted Eisaiβs Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and granted Priority Review. The Prescription Drugs User Fee Act action date (PDUFA) is set for January 6, 2023. The FDA has agreed that the results of Clarity AD can serve as a confirmatory study to verify the clinical benefit of lecanemab.”
References
Read more technical details about the drug trial here:
Biogen news release =: Β https://investors.biogen.com/news-releases/news-release-details/lecanemab-confirmatory-phase-3-clarity-ad-study-met-primary
Eisai news release:Β https://www.eisai.com/news/2022/news202271.html
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