STOCKHOLM, Nov. 4, 2021 /PRNewswire/ — BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) and associate Eisai in the present day introduced that they’ll maintain a number of oral shows revealing new information on lecanemab, on the 14th Medical Trials on Alzheimer’s Illness (CTAD) convention, November 9-12, 2021, in Boston, Massachusetts and just about. The shows will present deeper insights into lecanemab’s potential as a remedy for early Alzheimer’s illness.
Eisai lately initiated a rolling submission of a Biologics License Software (BLA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the remedy of early AD, to the U.S. Meals and Drug Administration (FDA) below the accelerated approval pathway. Eisai expects the rolling utility to be accomplished through the first half of 2022.
“CTAD is among the three key Alzheimer’s illness congresses yearly, and it is encouraging to see the good progress in each blood biomarkers and therapeutics of potential profit to sufferers. I am trying ahead to presenting new information on lecanemab compared with different anti-amyloid antibodies,” stated Lars Lannfelt, co-founder of BioArctic.
CTAD 2021 shows regarding lecanemab
Session, Time (Jap Commonplace Time)
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Title, Presenter/Writer
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Oral communication (onsite), Roundtable 5
Wednesday, November 10; 2:00 – 2:30 p.m.
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Evaluation of the Medical Results of Lecanemab, the Correlation of Plasma Aβ 42/40 Ratio with Adjustments in Mind Amyloid PET SUVr, and Security from the Core and Open Label Extension of the Part 2 Proof-of-Idea Examine, BAN2401-G000-201, in Topics with Early Alzheimer’s Illness
Presenters: Chad J. Swanson, Dr. Jeffrey Cummings, Dr. Randall Bateman and Dr. Christopher van Dyck
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Oral presentation (onsite), OC9
Wednesday, November 10; 2:45 – 3:00 p.m.
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Binding profiles to completely different amyloid-beta species of lecanemab, aducanumab and gantenerumab, the three most developed antibodies for Alzheimer’s illness
Presenter: Dr. Lars Lannfelt
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Oral communication (onsite), LB9
Thursday, November 11; 11:20 – 11:35 a.m.
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Consistency of Efficacy Assessments Throughout Numerous Statistical Strategies from the Lecanemab Part 2 Proof-of-Idea Examine, BAN2401-G000-201, in Topics with Early Alzheimer’s Illness
Presenter: DA Berry
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Oral communication (onsite), LB4
Thursday, November 11; 9:35 – 9:50 a.m.
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Introduction of Plasma Biomarker Screening for the AHEAD 3-45 Examine
Presenter: R. Sperling
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Oral communication (digital), ROC22
Friday, November 12; On-demand from 8:00 a.m.
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Baseline Traits for CLARITY-AD: A Part 3 Placebo-Managed, Double-Blind, Parallel-Group, 18-Month Examine Evaluating Lecanemab (BAN2401) in Early Alzheimer’s Illness
Presenter: C. Swanson
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Oral communication (digital), ROC23
Friday, November 12; On-demand from 8 a.m.
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A Stepwise Tier-Primarily based Method for Figuring out Affected person Eligibility in CLARITY AD: A Part 3 Placebo-Managed, Double-Blind Examine to Affirm the Security and Efficacy of Lecanemab (BAN2401) 10 mg/kg Biweekly in Sufferers with Early Alzheimer’s Illness
Presenter: M. Gee
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Since 2005, BioArctic has a long-term collaboration with Eisai relating to the event and commercialization of medicine for the remedy of Alzheimer’s illness. Eisai is chargeable for the scientific improvement, utility for market approval and commercialization of lecanemab for Alzheimer’s illness. BioArctic has no improvement prices for lecanemab in Alzheimer’s illness and is entitled to funds in reference to regulatory filings, approvals, and gross sales milestones.
“We’re very impressed with our associate Eisai’s development of lecanemab together with the rolling BLA below the accelerated approval pathway to the FDA, the confirmatory Part 3 Readability AD scientific trial, initiation of a lecanemab subcutaneous dosing Part 1 examine and the continued Part 3 AHEAD 3-45 examine in folks with pre-symptomatic Alzheimer’s illness. We’re trying ahead to the congress and deeper insights into lecanemab’s potential to assist sufferers with early Alzheimer’s illness,” stated BioArctic’s CEO Gunilla Osswald.
This launch discusses investigational makes use of of an agent in improvement and isn’t supposed to convey conclusions about efficacy or security. There isn’t any assure that any investigational makes use of of such product will efficiently full scientific improvement or achieve well being authority approval.
For additional info, please contact:
Gunilla Osswald, CEO
E-mail: gunilla.osswald@bioarctic.se
Telephone: +46 8 695 69 30
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Telephone: +46 70 410 71 80
This info is info that BioArctic AB (publ) is obliged to reveal pursuant to the EU Market Abuse Regulation. The data was launched for public disclosure, by the company of the contact individuals above, on November 4, 2021, at 08:00 a.m. CET.
Observe to editors
About lecanemab (BAN2401)
Lecanemab is an investigational humanized monoclonal antibody for Alzheimer’s illness (AD) that’s the results of a strategic analysis alliance between Eisai and BioArctic. Lecanemab selectively binds to, neutralize and get rid of soluble poisonous Aβ aggregates (protofibrils) which can be thought to contribute to the neurodegenerative course of in AD. As such, lecanemab could have the potential to affect illness pathology and to decelerate the development of the illness. Eisai obtained the worldwide rights to review, develop, manufacture, and market lecanemab for the remedy of AD pursuant to an settlement concluded with BioArctic in December 2007. In March 2014, Eisai and Biogen entered right into a joint improvement and commercialization settlement for lecanemab. Presently, lecanemab is being studied in a pivotal Part 3 scientific examine in symptomatic early AD (Readability AD), following the end result of the Part 2b scientific examine (Examine 201). In July of 2020, the Part 3 scientific examine, AHEAD 3-45, for people with preclinical (asymptomatic) AD, that means they’re clinically regular and have intermediate or elevated ranges of mind amyloid, was initiated. AHEAD 3-45 is performed as a public-private partnership between the Alzheimer’s Medical Trial Consortium, funded by the Nationwide Institute on Getting old, a part of the Nationwide Institutes of Well being and Eisai. In June 2021, FDA granted lecanemab Breakthrough Remedy designation and in September 2021, Eisai initiated a rolling submission for the US FDA Biologics license utility of lecanemab for early Alzheimer’s illness below the accelerated approval pathway.
In regards to the collaboration between BioArctic and Eisai
Since 2005, BioArctic has long-term collaboration with Eisai relating to the event and commercialization of medicine for the remedy of Alzheimer’s illness. An important agreements are the Growth and Commercialization Settlement for the lecanemab antibody, which was signed in December 2007, and the Growth and Commercialization settlement for the antibody BAN2401 back-up for Alzheimer’s illness, which was signed in Might 2015. Eisai is chargeable for the scientific improvement, utility for market approval and commercialization of the merchandise for Alzheimer’s illness. BioArctic has no improvement prices for lecanemab in Alzheimer’s illness and is entitled to funds in reference to regulatory filings, approvals, and gross sales milestones.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma firm specializing in disease-modifying remedies and dependable biomarkers and diagnostics for neurodegenerative illnesses, similar to Alzheimer’s illness and Parkinson’s illness. BioArctic focuses on progressive remedies in areas with excessive unmet medical wants. The corporate was based in 2003 primarily based on progressive analysis from Uppsala College, Sweden. Collaborations with universities are of nice significance to the corporate along with its strategically vital world companions within the Alzheimer (Eisai) and Parkinson (AbbVie) tasks. The challenge portfolio is a mixture of totally funded tasks run in partnership with world pharmaceutical firms and progressive in-house tasks with vital market and out-licensing potential. BioArctic’s Class B share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B). For extra details about BioArctic, please go to www.bioarctic.com
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