STOCKHOLM, Sept. 28, 2022 /PRNewswire/ — BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) accomplice Eisai as we speak introduced constructive topline outcomes for the massive world Phase 3 confirmatory Clarity AD study in 1,795 topics. The study met the primary endpoint (CDR-SB1: Clinical Dementia Rating-Sum of Boxes) exhibiting a extremely statistically important discount of scientific decline. All key secondary endpoints had been additionally met demonstrating extremely statistically important outcomes. Clarity AD is a scientific trial of lecanemab (improvement code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the therapy of delicate cognitive impairment (MCI) as a result of Alzheimer’s disease (AD) and delicate AD (collectively often called early AD), with confirmed presence of amyloid pathology in the mind. The relative danger in Clarity AD of the primary facet impact related with anti-amyloid therapies, ARIA, was inside expectations. Eisai will focus on this knowledge with regulatory authorities in the U.S., Japan and Europe with the intention to file for conventional approval in the US and for advertising and marketing authorization functions in Japan and Europe by the tip of the primary quarter of 2023. Additionally, Eisai will current the Clarity AD study outcomes on November 29, 2022, on the Clinical Trials on Alzheimer’s Disease convention (CTAD) and publish the findings in a peer-reviewed medical journal.
Lecanemab therapy met the primary endpoint and lowered scientific decline on the worldwide cognitive and purposeful scale, Clinical Dementia Rating-Sum of Boxes (CDR-SB) in contrast with placebo at 18 months by 27%, which represents a therapy distinction in the rating change of -0.45 (p=0.00005) in the evaluation of Intent-to-treat (ITT) inhabitants. Starting as early as six months, throughout all time factors, the therapy confirmed extremely statistically important modifications in CDR-SB from baseline in comparison with placebo (all p-values had been lower than 0.01). All key secondary endpoints had been additionally met with extremely statistically important outcomes in contrast with placebo (p<0.01). Key secondary endpoints had been the change from baseline at 18 months in contrast with placebo of therapy in amyloid ranges in the mind measured by amyloid positron emission tomography (PET), the AD Assessment Scale-cognitive subscale14 (ADAS-cog 14), AD Composite Score (ADCOMS) and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL).
The incidence of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an hostile occasion related with anti-amyloid antibodies, was 12.5% in the lecanemab group and 1.7% in the placebo group. The incidence of symptomatic ARIA-E was 2.8% in the lecanemab group and 0.0% in the placebo group. The ARIA-H (ARIA cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis) price was 17.0% in the lecanemab group and 8.7% in the placebo group. The incidence of symptomatic ARIA-H was 0.7% in the lecanemab group and 0.2% in the placebo group. There was no imbalance in remoted ARIA-H (i.e., ARIA-H in sufferers who didn’t additionally expertise ARIA-E) between lecanemab (8.8%) and placebo (7.6%). The complete incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group. Overall, the relative danger profile of ARIA for lecanemab was inside expectations
Clarity AD was a worldwide confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 individuals with early AD. The therapy group was administered lecanemab 10 mg/kg bi-weekly, with contributors allotted in a 1:1 ratio to obtain both placebo or lecanemab. The baseline traits of each placebo and lecanemab teams was related and properly balanced. Eligibility standards allowed sufferers with a broad vary of comorbidities/comedications: hypertension, diabetes, coronary heart disease, weight problems, renal disease, anti-coagulants, and so forth. Eisai’s recruitment technique for the Clarity AD scientific trial ensured larger inclusion of ethnic and racial populations in the U.S., ensuing in roughly 25% of the full U.S. enrollment together with Hispanic and African American individuals residing with early AD. Due to the inclusive eligibility standards and the profitable recruitment of various ethnic and racial populations in the U.S., Clarity AD’s inhabitants is usually similar to the nation’s Medicare inhabitants.
“We are very excited about the great lecanemab Phase 3 results in early Alzheimer’s disease announced by our partner Eisai today. It brings hope to millions of people around the world who are fighting Alzheimer’s disease every day. The Clarity AD results fully meet all our expectations, both in terms of highly statistical significance and in the consistency over primary and all key secondary endpoints. This is a huge accomplishment by our employees and our partner Eisai who have worked tirelessly for almost two decades to make this project a success. We are proud that our founder Lars Lannfelt’s discoveries has the potential to fundamentally improve the treatment of Alzheimer’s disease, where there currently are very limited options,” mentioned BioArctic’s CEO Gunilla Osswald. “The results are also a confirmation of our technology platform and strengthens our hope to also be able to help improve the treatment of other neurodegenerative diseases such as Parkinson’s disease, ALS and others.”
In July 2022, the U.S. Food and Drug Administration (FDA) accepted Eisai’s Biologics License Application (BLA) for lecanemab underneath the Accelerated Approval Pathway and granted Priority Review. The Prescription Drugs User Fee Act motion date (PDUFA) is ready for January 6, 2023. The FDA has agreed that the outcomes of Clarity AD can function the confirmatory study to confirm the scientific advantage of lecanemab. In an effort to safe conventional FDA approval for lecanemab as quickly as doable, Eisai submitted the BLA via the FDA’s Accelerated Approval Pathway in order that the company may full its evaluate of all lecanemab knowledge with the exception of the info from the confirmatory Clarity AD study.
In March 2022, Eisai started submitting utility knowledge, with the exception of Clarity AD knowledge, to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) underneath the prior evaluation session system with the intention of acquiring early approval for lecanemab so that individuals residing with early AD could have entry to the remedy as quickly as doable.
Eisai goals to file for conventional approval in the U.S., and to submit advertising and marketing authorization functions in Japan and Europe by the tip of the primary quarter 2023.
This launch discusses investigational makes use of of an agent in improvement. There is not any assure that any investigational makes use of of such product will efficiently achieve well being authority approval.
This info is info that BioArctic AB (publ) is obliged to reveal pursuant to the EU Market Abuse Regulation. The info was launched for public disclosure, via the company of the contact individuals above, on September 28, 2022, at 01:30 a.m. CET.
For additional info, please contact:
Gunilla Osswald, CEO
E-mail: [email protected]
Phone: +4686956930
Oskar Bosson, VP Communications and IR
E-mail: [email protected]
Phone: +46704107180
About Clarity AD
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Study title |
A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer’s Disease (Clarity AD)
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Study inhabitants |
1,795 contributors of delicate cognitive impairment (MCI) as a result of Alzheimer’s disease (AD) and delicate AD (collectively often called early AD) with confirmed presence of amyloid pathology in the mind in the worldwide study, and an extra 111 topics ongoing in China.
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Treatment administered |
10 mg/kg bi-weekly of lecanemab or placebo
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Duration of therapy |
18 months
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Study areas |
Japan, the U.S., Europe and China
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Primary endpoint |
Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months
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Key secondary endpoints |
Change From Baseline in:
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About lecanemab (BAN2401)
Lecanemab is an investigational humanized monoclonal antibody for Alzheimer’s disease (AD) that’s the results of a strategic analysis alliance between BioArctic and Eisai. Lecanemab selectively binds to neutralize and eradicate soluble poisonous Aβ aggregates (protofibrils) which are thought to contribute to the neurodegenerative course of in AD. As such, lecanemab could have the potential to impact disease pathology and to decelerate the development of the disease. Currently, lecanemab is being developed as the one late-stage anti-Aβ antibody that can be utilized for the therapy of early AD with out the necessity for titration, enabling full therapy impact from day one.
The Clarity AD open-label extension is underway with therapy initiated after completion of the Core interval to additional consider the protection and efficacy of lecanemab. In addition, the lecanemab Phase 3 scientific study AHEAD 3-45 is ongoing for people with preclinical (asymptomatic) AD, which means they’re clinically regular and have intermediate or elevated ranges of mind amyloid. AHEAD 3-45 is carried out as a public-private partnership between the Alzheimer’s Clinical Trial Consortium, funded by the National Institute on Aging, a part of the National Institutes of Health, and Eisai. In 2021, lecanemab was chosen for the Tau NexGen scientific study for Dominantly Inherited Alzheimer’s disease (DIAD), as a background anti-amyloid therapy when exploring mixture therapies with anti-tau therapies. The study, which is ongoing, is carried out by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis. Furthermore, Eisai has carried out a lecanemab subcutaneous dosing Phase 1 study and the subcutaneous formulation is presently being evaluated in the Clarity AD open label extension study.
About Amyloid Related Imaging Abnormalities (ARIA)
ARIA is a vital hostile occasion of amyloid-lowering therapies that’s crucial to observe and handle throughout therapy. ARIA is mostly seen as short-term swelling/effusion (ARIA-E) in areas of the mind that normally resolves over time. Some individuals can also have small spots of bleeding in or on the floor of the mind (ARIA-H; cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis) in isolation or with the swelling. Although most individuals with ARIA should not have signs, some individuals could have signs equivalent to: headache, confusion, dizziness, imaginative and prescient modifications, and nausea.
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai relating to the event and commercialization of medication for the therapy of Alzheimer’s disease. The most essential agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed in December 2007, and the Development and Commercialization settlement for the antibody BAN2401 back-up for Alzheimer’s disease, which was signed in May 2015. In March 2014, Eisai and Biogen entered right into a joint improvement and commercialization settlement for lecanemab. Eisai is answerable for the scientific improvement, utility for market approval and commercialization of the merchandise for Alzheimer’s disease. BioArctic has proper to commercialize lecanemab in the Nordic underneath sure situations and is presently making ready for commercialization in the Nordics collectively with Eisai. BioArctic has no improvement prices for lecanemab in Alzheimer’s disease and is entitled to funds in connection with regulatory filings, approvals, and gross sales milestones in addition to royalties on world gross sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma firm specializing in disease-modifying therapies for neurodegenerative illnesses, equivalent to Alzheimer’s disease, Parkinson’s disease and ALS. BioArctic focuses on progressive therapies in areas with high unmet medical wants. The firm was based in 2003 based mostly on progressive analysis from Uppsala University, Sweden. Collaborations with universities are of nice significance to the corporate collectively with its strategically essential world accomplice Eisai in Alzheimer disease. The challenge portfolio is a mixture of totally funded tasks run in partnership with world pharmaceutical firms and progressive in-house tasks with important 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.
1 CDR-SB is a numeric scale used to quantify the varied severity of signs of dementia. Based on interviews of individuals residing with AD and household/caregivers, certified healthcare professionals assess a cognitive and purposeful efficiency in six areas: reminiscence, orientation, judgment and drawback fixing, neighborhood affairs, residence and hobbies, and private care. The complete rating of the six areas is the rating of CDR-SB, and CDR-SB can be used as an applicable merchandise for evaluating the effectiveness of therapeutic medicine focusing on early levels of AD.
2 ADAS-cog is the most typical cognitive evaluation instrument used in Alzheimer’s disease scientific trials all over the world. ADAS-cog14 consists of 14 competencies: phrase recall, instructions, constructional praxis, object and finger naming, ideational praxis, orientation, phrase recognition, remembering phrase recognition directions, comprehension of spoken language, phrase discovering issue, spoken language potential, delayed phrase recall, quantity cancellation, and maze process. ADAS-cog has been used in trials for earlier levels of AD together with MCI.
3 Developed by Eisai, combines objects from the ADAS-cog scale for assessing cognitive features, MMSE and the CDR scale for evaluating the severity of dementia to allow extremely delicate detection of modifications in scientific features of early AD signs and modifications in reminiscence
4 ADCS-MCI-ADL assesses the competence of sufferers with MCI in actions of every day residing (ADLs), based mostly on 24 inquiries to the affected person’s accomplice about precise latest actions of every day residing.
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