Global research and development-based pharmaceutical company Eisai Co. Ltd. (ESALY:OTC;ESALY:OTCMKTS) and Biogen Inc. (BIIB:NASDAQ), yesterday announced positive topline data from the Phase 3 Clarity AD clinical trial of lecanemab conducted by Eisai Co.
The companies advised that the global study enrolled a total of 1,795 participants who were diagnosed with early Alzheimer's Disease (AD). The confirmatory study was designed to evaluate the effectiveness of lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for use in treating both mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD. The report noted that together these conditions are referred to as "early AD," accompanied by amyloid pathology in the brain.
The firm stated that it plans to discuss the results from the large global study with regulatory agencies in it the U.S. to seek traditional approval and hopes to file requests for marketing authorization applications in Japan and the EU before the end of March 2023.
Eisai stated that in the study, Lecanemab successfully achieved the primary endpoint based upon the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale, which is used to calculate the severity of dementia-related symptoms. In addition, the company mentioned that it also met all key secondary endpoints with highly statistically significant results as well.
The firm stated that it plans to discuss the results from the large global study with regulatory agencies in it the U.S. to seek traditional approval and hopes to file requests for marketing authorization applications in Japan and the EU before the end of March 2023.
In the Phase 3 Clarity AD clinical trial, subjects treated with lecanemab demonstrated a 27% reduction in clinical decline at 18 months versus the control group as measured by the global cognitive and functional CDR-SB scale. The company advised that "starting as early as six months, across all time points, the treatment showed highly statistically significant changes in CDR-SB from baseline compared to placebo."
Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimer's disease as well as further activate innovation for new treatment options.
The firm stated that all key secondary endpoints were also met with highly statistically significant results when compared to the participants who were given a placebo. The firm listed that these secondary endpoints included changes from baseline at 18 months in amyloid levels in the brain and improvement in results from several AD cognitive impairment assessment tests.
The company indicated that the Phase 3 Clarity AD trial was a double-blind, randomized study of 1,795 individuals identified as having early AD. The treated group was given bi-weekly 10 mg/kg doses of lecanemab.
Eisai's CEO Haruo Naito commented, "Since Eisai launched Aricept in the U.S. and Japan in the late 1990s and obtained its approval in over 100 countries, Eisai has provided the drug to people living with dementia while building empathy for them and their families through disease education efforts and community involvement. The positive result of the lecanemab, an anti-Aβ protofibril antibody, pivotal study after almost 25 years since Aricept's launch is an important milestone for Eisai in fulfilling our mission to meet the expectations of the Alzheimer's disease community."
"The lecanemab Clarity AD study results prove the amyloid hypothesis, in which the abnormal accumulation of Aβ in the brain is one of the main causes of Alzheimer's disease when targeted with a protofibril-binding therapy. Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimer's disease as well as further activate innovation for new treatment options," Naito added.
Biogen's CEO Michel Vounatsos remarked, "Today's announcement gives patients, and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer's disease and provide a clinically meaningful impact on cognition and function … Importantly, 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."
According to the report, Eisai's Biologics License Application (BLA) for lecanemab was accepted by the U.S. Food and Drug Administration (FDA) in In July 2022, and "a Prescription Drugs User Fee Act action date (PDUFA) is set for January 6, 2023."
The company explained that "lecanemab is an investigational humanized monoclonal antibody for AD that selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD." Eisai believes that lecanemab shows great promise for affecting disease pathology and slowing down AD progression.
The report pointed out that Eisai and Biogen have been working together to develop and commercialize AD treatments since 2014. Eisai is tasked with the responsibility of leading lecanemab development and regulatory submissions worldwide, with both firms assuming co-marketing and promotion efforts.
In December 2007, prior to teaming up with Biogen, Eisai obtained the global rights from BioArctic to study, develop, manufacture, and market lecanemab for the treatment of AD. The report listed that later it signed a development and commercialization agreement relating to the antibody lecanemab in May 2015.
Eisai Co. Ltd. is a research and development-based pharmaceutical firm headquartered in Tokyo, Japan. The firm strategically focuses on the areas of neurology and oncology and operates a global network of R&D facilities, manufacturing sites, and marketing subsidiaries. The firm mentioned it is also dedicated to eliminating neglected tropical diseases.
Biogen is a biopharmaceutical company based in Cambridge, Mass. The company has a market cap of about US$29 billion and specializes in discovering and developing therapies for use in treating serious neurological and neurodegenerative diseases. The firm's portfolio includes medicines for use in treating multiple sclerosis, spinal muscular atrophy, and Alzheimer's disease.
Eisai Co. Ltd. started yesterday off with a market cap of around US$11.42 billion with approximately 286.9 million shares outstanding. ESALY ADR shares opened 56% higher yesterday at US$62.00 (+$22.21, +55.82%) over the previous day's US$39.79 closing price. The stock traded between US$62.00 and US$68.00 per share yesterday and closed for trading at US$62.72 (+22.93, +57.63%). It is currently trading at US$58.13.
| Want to be the first to know about interesting Biotechnology / Pharmaceuticals investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter. | Subscribe |
Disclosures:
1) Stephen Hytha wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
