Le Lézard
Classified in: Health, Covid-19 virus
Subjects: PDT, TRI

EISAI PRESENTS NEW LEQEMBI® (LECANEMAB-IRMB) INVESTIGATIONAL SUBCUTANEOUS FORMULATION INTERIM STUDY RESULTS AND CLINICAL IMPROVEMENT DATA IN EARLIER STAGES OF EARLY ALZHEIMER'S DISEASE FROM ADDITIONAL ANALYSES OF CLARITY AD AT THE CLINICAL TRIALS ON ALZHEIMER'S DISEASE (CTAD) CONFERENCE


INVESTIGATIONAL SUBCUTANEOUS FORMULATION CLEARS 14% MORE PLAQUE THAN IV, PHARMACOKINETICS (AUC) 11% HIGHER, AND SIMILAR ARIA RATES TO IV

76% OF PATIENTS SHOWED NO DECLINE AND 60% SHOWED CLINICAL IMPROVEMENT AT 18 MONTHS IN LOW-TAU SUBPOPULATION IN ADDITIONAL ANALYSIS OF CLARITY AD

DUAL-ACTING LEQEMBI SUPPORTS BRAIN NEURON FUNCTION BY REMOVING HIGHLY TOXIC PROTEINS (PROTOFIBRILS) THAT CAN CONTINUE TO CAUSE NEURONAL INJURY AND DEATH EVEN AFTER PLAQUE REMOVAL, OFFERING EARLY AD PATIENTS THE OPPORTUNITY FOR CONTINUED BENEFIT

TOKYO and CAMBRIDGE, Mass., Oct. 25, 2023 /CNW/ - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that Eisai presented new data for LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous (IV) use, in the Late Breaking Symposium 4 "Lecanemab for Early Alzheimer's Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration" at the 16th annual Clinical Trials on Alzheimer's Disease (CTAD) conference held in Boston, Massachusetts, United States and virtually October 24-27, 2023.

U.S. journalists may experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9211051-eisai-at-ctad2023

1. Subcutaneous Formulation Interim Data; Safety And Effects On Brain Amyloid

1) Weekly subcutaneous (SC) administration showed 14% greater amyloid plaque removal than biweekly IV administration as suggested in a preliminary analysis using amyloid PET at 6 months of treatment.

2) SC Pharmacokinetics (AUC) Higher Than IV By 11%

3) Lower Systemic Injection Reaction Rates With SC As Compared To IV

4) ARIA Rates Of IV Formulation In Clarity AD Core Study Consistent With Rates In First-Time LEQEMBI Patients Entering The SC Substudy In Clarity AD OLE

Eisai aims to submit a LEQEMBI SC formulation Biologics License Application (BLA) with the U.S. Food and Drug Administration by March 31, 2024.

2. Latest Data From Tau Pet Longitudinal Substudy, Including A Post-Hoc Analysis Of The Low And Intermediate + High-Tau Subpopulations In The Clarity AD 18 Month Core Study

1) 76% of patients showed no decline and 60% showed clinical improvement at 18 months in low-tau / earlier stage early AD population.

2) Tau PET Substudy Showed LEQEMBI Slows Development Of Tau Tangles In Early AD; Tau Spread In The Brain Is A Hallmark Of Disease Progression.

3. Efficacy Results From LEQEMBI Clarity AD Open-Label Extension Study

1) LEQEMBI Patients Continued to Show Benefit at 24 Months of Treatment 

4. The Mechanism-Based Rationale Of LEQEMBI Treatment In Early AD

1) Dual-Acting LEQEMBI3 Continues To Support Brain Neuron Function3,4,5 By Removing Highly Toxic Proteins (Protofibrils****)2,4 That Can Cause Neuronal Injury And Death Even After Plaque Removal,5-8 Offering Patients The Opportunity For Continued Benefit. 

Eisai is hosting a live webcast of the scientific session featuring the LEQEMBI presentations, which can be viewed on the investors section of the Eisai Co., Ltd. website. The content will be available on demand afterward.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

*Phase III Clarity AD study is a placebo-controlled, double-blind, parallel-group, randomized study to evaluate the efficacy and safety of LEQEMBI 10 mg/kg bi-weekly for 18 months in 1,795 people living with early AD (core study). An OLE is being conducted after the core study. SC dosing is currently being evaluated in the Clarity AD OLE.

**Using the MK6240 tau PET probe, tau accumulation in the brain was defined as low tau accumulation group (MK6240 cutoff value <1.06, 141 subjects), intermediate accumulation group (MK6240 cutoff value between 1.06 and 2.91, 191 subjects), and high accumulation group (MK6240 cutoff value >2.91, 10 subjects).

***Multiple endpoints: CDR-SB, a numeric scale used to quantify the severity of symptoms of dementia; ADAS-Cog14, common cognitive assessment instrument used in AD clinical trials all over the world; and ADCS MCI-ADL, a scale to assess the parties' activities of daily living.

****Protofibrils:

INDICATION

LEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

WARNING: AMYLOID RELATED IMAGING ABNORMALITIES (ARIA)

  • Monoclonal antibodies directed against aggregated forms of amyloid beta, including LEQEMBI, can cause
    amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with
    hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs
    early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.
    Serious intracerebral hemorrhages >1 cm, some of which have been fatal, have been observed in patients
    treated with this class of medications.
    • Apolipoprotein E ?4 (ApoE ?4) Homozygotes: Patients who are ApoE ?4 homozygotes
      (approximately 15% of Alzheimer's disease patients) treated with this class of medications,
      including LEQEMBI, have a higher incidence of ARIA, including symptomatic, serious, and severe
      radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE ?4 status should
      be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing,
      prescribers should discuss with patients the risk of ARIA across genotypes and the implications of
      genetic testing results. Prescribers should inform patients that if genotype testing is not performed,
      they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE ?4
      homozygotes and at higher risk for ARIA.
  • Consider the benefit of LEQEMBI for the treatment of Alzheimer's disease and potential risk of serious
    adverse events associated with ARIA when deciding to initiate treatment with LEQEMBI

CONTRAINDICATION

LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients of LEQEMBI. Reactions have included angioedema and anaphylaxis.

WARNINGS AND PRECAUTIONS

Amyloid Related Imaging Abnormalities

ARIA Monitoring and Dose Management Guidelines

Incidence of ARIA

ApoE ?4 Carrier Status and Risk of ARIA

Radiographic Findings

Intracerebral Hemorrhage

Concomitant Antithrombotic Medication:

Other Risk Factors for Intracerebral Hemorrhage:

Hypersensitivity Reactions

Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred in LEQEMBI-treated patients. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction, and initiate appropriate therapy.

Infusion-Related Reactions

ADVERSE REACTIONS

Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.

MEDIA CONTACTS

 


Eisai Co., Ltd.

Public Relations
Department

TEL: +81 (0)3-3817-5120

 

Eisai Inc. (U.S.)

Libby Holman

+ 1-201-753-1945

[email protected]

 

Eisai Europe, Ltd.

(UK, Europe, Australia,
New Zealand and Russia)

EMEA Communications
Department

+44 (0) 786 601 1272

[email protected]

 

Biogen Inc.

Jack Cox

+ 1-781-464-3260

[email protected] 

INVESTOR CONTACTS

 


Eisai Co., Ltd.

Investor Relations
Department

TEL: +81 (0) 3-3817-5122

Biogen Inc.

Chuck Triano

+ 1-781-464-2442

[email protected]


[Notes to editors]

1. About Lecanemab (generic name, U.S. brand name: LEQEMBI®),

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (A?). In the U.S., LEQEMBI was granted traditional approval by the U.S. Food and Drug Administration (FDA) on July 6, 2023. LEQEMBI is an amyloid beta-directed antibody indicated as a disease-modifying treatment for Alzheimer's disease (AD) in the U.S. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. In Japan, Eisai received approval from the Ministry of Health, Labour and Welfare (MHLW) on September 25, 2023 to manufacture and market of lecanemab as a treatment for slowing progression of MCI and mild dementia due to AD.

Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING.

Eisai has also submitted applications for approval of lecanemab in EU, China, Canada, Great Britain, Australia, Switzerland, South Korea and Israel. In China and Israel, the applications have been designated for priority review, and in Great Britain, lecanemab has been designated for the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time to market for innovative medicines.

Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing is still being evaluated in the Clarity AD (Study 301) open-label extension (OLE). A maintenance dosing regimen has been evaluated as part of Study 201.

Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen.

Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

2. About the Collaboration between Eisai and Biogen for AD

Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

3. About the Collaboration between Eisai and BioArctic for AD

Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market LEQEMBI for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody LEQEMBI back-up was signed in May 2015.

4. About Eisai Co., Ltd.

Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on XLinkedIn and Facebook.

5. About Biogen

Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer's disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media ? XLinkedInFacebookYouTube.

Biogen Safe Harbor

This news release contains forward-looking statements about the potential clinical effects of LEQEMBI; the potential benefits, safety and efficacy of LEQEMBI; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including LEQEMBI; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial, AHEAD 3-45 study and SC substudy; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including LEQEMBI; actual timing and content of submissions to and decisions made by the regulatory authorities regarding LEQEMBI; uncertainty of success in the development and potential commercialization of LEQEMBI; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements.

References

  1. van Dyck, C., Irizarry, M., Johnson, K., & Sperling, R. (2023, October 24-27). Lecanemab for Early Alzheimer's Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration [Conference Presentation]. Clinical Trials on Alzheimer's Disease Conference, Boston, MA, United States.
  2. Hampel, H., Hardy, J., Blennow, K. et al. The Amyloid-? Pathway in Alzheimer's Disease. Mol Psychiatry. 2021;26:5481?5503. https://doi.org/10.1038/s41380-021-01249-0.
  3. LEQEMBI US Prescribing Information.
  4. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer's disease. N Engl J Med. 2023;388(1):9-21.
  5. Brendza RP, et al. Anti-A? antibody treatment promotes the rapid recovery of amyloid-associated neuritic dystrophy in PDAPP transgenic mice J Clin Invest. 2005;115(2):428-433. https://doi.org/10.1172/JCI23269.
  6. Ono K, Tsuji M. Protofibrils of Amyloid-? are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. Doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
  7. Söderberg L, et al. Lecanemab, Aducanumab, and Gantenerumab ? Binding Profiles to Different Forms of Amyloid?Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer's Disease. Neurotherapeutics (2023) 20:195?206 https://doi.org/10.1007/s13311-022-01308-6 Accessed October 12, 2023.
  8. Hartley DM, Walsh DM, Ye CP, Diehl T, Vasquez S, Vassilev PM, Teplow DB, Selkoe DJ. Protofibrillar intermediates of amyloid beta-protein induce acute electrophysiological changes and progressive neurotoxicity in cortical neurons. J Neurosci. 1999;19(20):8876-84. doi: 10.1523/JNEUROSCI.19-20-08876.1999. PMID: 10516307; PMCID: PMC6782787.
  9. Alzheimer's Association. (2022). Brain Tour Part 2 - Alzheimer's Effect. Retrieved September 27, 2023, from https://www.alz.org/alzheimers-dementia/what-is-alzheimers/brain_tour_part_2.
  10. Chen, Gf., Xu, Th., Yan, Y. et al. Amyloid beta: structure, biology and structure-based therapeutic development. Acta Pharmacol. 2017;38:1205. https://doi.org/10.1038/aps.2017.28.
  11. Habashi M., Vulta S., Tripathi K., et al. Early diagnosis and treatment of Alzheimer's disease by targeting toxic soluble A? oligomers. Biophysics and Computational Biology. 2022;10.1073. https://www.pnas.org/doi/epdf/10.1073/pnas.2210766119.
  12. Amin L, Harris DA. A? receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z.

SOURCE Eisai Canada


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