STOCKHOLM, March 11, 2022 /PRNewswire/ — BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) introduced as we speak that the corporate and its collaboration associate Eisai will each current knowledge regarding its investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401), on the sixteenth Worldwide Convention on Alzheimer’s and Parkinson’s Illnesses and associated neurological problems, AD/PD™ 2022 in Barcelona and on-line.
The Worldwide Convention on Alzheimer’s and Parkinson’s Illnesses and associated neurological problems is a key scientific occasion with a concentrate on enhancing the therapy of Alzheimer’s, Parkinson’s and different associated neurodegenerative illnesses.
BioArctic’s founder Professor Lars Lannfelt, might be presenting on the subject of the science of the amyloid-beta cascade in addition to the distinct mechanisms of motion of lecanemab. His presentation will even embody knowledge on lecanemab compared with different late-stage anti-amyloid antibodies.
Eisai will current knowledge from the Part 2b research of lecanemab in early Alzheimer’s illness and the continuing open-label extension research, together with new biomarker knowledge. Eisai will even replace on the scientific improvement of lecanemab together with subcutaneous improvement and the Dominantly Inherited Alzheimer’s Community Trials Unit (DIAN-TU) Tau Nexgen research, the place lecanemab might be used as a background therapy together with an investigational tau remedy.
Lecanemab was granted Breakthrough Remedy and Quick Monitor designations by the U.S. Meals and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates finishing lecanemab’s rolling submission of a Biologics License Utility for the therapy of early AD to the FDA beneath the accelerated approval pathway within the second quarter 2022. Moreover, the readout of the Part 3 confirmatory Readability AD scientific trial is predicted by finish of September 2022. Eisai initiated a submission to the Prescribed drugs and Medical Units Company (PMDA) of software knowledge of lecanemab beneath the prior evaluation session system in Japan in March 2022.
Session, date and time (CET), presenter |
Matter
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Symposium: Advances in AD, PD and LBD drug improvement Thursday March 17 Lecture Time: 10:25 AM – 10:40 AM Presenter: Lon S. Schneider |
Dominantly Inherited Alzheimer’s Community Trials Unit (DIAN-TU) Tau Nexgen Platform Trial of the Anti-tau Antibody, E2814 with Background Lecanemab Remedy
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Symposium: Aβ focusing on therapies in AD 2 Friday March 18 Lecture time: 05:15 PM – 05:40 PM Presenter: Lars Lannfelt |
Science of the amyloid-β cascade and distinct mechanisms of motion of lecanemab
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Symposium: Aβ focusing on therapies in AD 2 Friday March 18 Lecture time: 05:40 PM – 05:55 PM Presenter: Marwan Sabbagh |
Key trial design elements and scientific outcomes of the lecanemab section 2 trial and open-label extension in early Alzheimer’s illness
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Symposium: Aβ focusing on therapies in AD 2 Friday March 18 Lecture Time: 05:55 PM – 06:10 PM Presenter: Eric McDade |
Biomarker outcomes from the lecanemab section 2 research: linking illness development to persistent amyloid therapy
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Symposium: Aβ focusing on therapies in AD 2 Friday March 18 Lecture Time: 06:10 PM – 06:25 PM Presenter: Michael C. Irizarry |
Replace on lecanemab scientific improvement, together with new subcutaneous (SC) formulation
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Symposium: Aβ and different focusing on therapies in AD Sunday March 20 Lecture Time: 09:05 AM – 09:20 AM Presenter: Antonio Cabal |
Quantitative Programs Pharmacology Amyloid Platform: Multiscale Computational Modeling of Aβ Biology and Its Interplay with Lecanemab Pharmacology
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On demand presentation Presenter: Arnaud Charil |
Baseline Tau in Readability AD: A Part 3 Placebo-Managed, Double-Blind, Parallel-Group, 18-Month Research Evaluating Lecanemab in Early Alzheimer’s Illness
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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 data, please contact:
Gunilla Osswald, CEO, BioArctic AB
E-mail: gunilla.osswald@bioarctic.se
Telephone: +46 8 695 69 30
Oskar Bosson, Vice President Communications and Investor Relations, BioArctic AB
E-mail: oskar.bosson@bioarctic.se
Telephone: +46 70 410 71 80
This data was submitted for publication at 08:00 a.m. CET on March 11, 2022.
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 remove soluble poisonous Aβ aggregates (protofibrils) which might be thought to contribute to the neurodegenerative course of in AD. As such, lecanemab might have the potential to impact illness pathology and to decelerate the development of the illness. Eisai obtained the worldwide rights to review, develop, manufacture, and market lecanemab for the therapy 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 research in symptomatic early AD (Readability AD), following the result of the Part 2b scientific research (Research 201). As well as, the Part 3 scientific research, AHEAD 3-45, for people with preclinical (asymptomatic) AD, which means they’re clinically regular and have intermediate or elevated ranges of mind amyloid, is ongoing. AHEAD 3-45 is carried out as a public-private partnership between the Alzheimer’s Medical Trial Consortium, funded by the Nationwide Institute on Ageing, 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 software of lecanemab for early Alzheimer’s illness beneath the accelerated approval pathway. In December 2021, FDA granted lecanemab Quick monitor designation and the second a part of the rolling software was submitted. Eisai expects the rolling submission to be accomplished throughout the second quarter 2022.
Concerning the collaboration between BioArctic and Eisai
Since 2005, BioArctic has long-term collaboration with Eisai concerning the event and commercialization of medicine for the therapy of Alzheimer’s illness. Crucial 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, software 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 therapies and dependable biomarkers and diagnostics for neurodegenerative illnesses, equivalent to Alzheimer’s illness and Parkinson’s illness. BioArctic focuses on progressive therapies 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 essential international companions within the Alzheimer (Eisai) and Parkinson (AbbVie) tasks. The challenge portfolio is a mixture of totally funded tasks run in partnership with international 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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SOURCE BioArctic