New data from LEQEMBI (lecanemab-irmb) phase 3 Clarity AD study and subcutaneous formulation presented at CTAD (2)

(Información remitida por la empresa firmante)

STOCKHOLM, Oct. 25, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today presented new data on the investigational subcutaneous formulation of LEQEMBI showing that it clears 14% more amyloid plaques as measured by PET compared to intravenous infusion (IV), with pharmacokinetics (AUC) 11% higher and similar ARIA rates. An additional analysis of the phase 3 Clarity AD data for LEQEMBI in the PET low tau population revealed that 76% of patients in the low tau population showed no decline and 60% showed clinical improvement at 18 months of treatment.

The data was presented in the Late Breaking Symposium 4 "Lecanemab for Early Alzheimer's Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration" at the 16^th annual Clinical Trials on Alzheimer's Disease (CTAD) conference held in Boston, Massachusetts, United States and virtually October 24-27, 2023. Eisai aims to submit a LEQEMBI subcutaneous formulation Biologics License Application (BLA) with the U.S. Food and Drug Administration by March 31, 2024.

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. BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

This release discusses investigational uses of an agent 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.

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

The information was released for public disclosure, through the agency of the contact persons below, on October 25, 2023, at 11.25 p.m. CET.

For further information, please contact: Oskar Bosson, VP Communications and IRE-mail: oskar.bosson@bioarctic.sePhone: +46 70 410 71 80

Jiang Millington, Director Corporate Communication and Social Media E-mail: jiang.millington@bioarctic.sePhone: +46 79 33 99 166

About lecanemab (generic name, U.S. and Japan brand name: LEQEMBI)Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. 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 US 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 US. 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. In Japan, Eisai received approval from the Ministry of Health, Labour and Welfare (MHLW) on September 25, 2023, to manufacture and market lecanemab as a treatment for slowing progression of MCI and mild dementia due to AD.

Please see full U.S. Prescribing Information, 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 currently being evaluated in the Clarity AD (Study 301) open-label extension (OLE) study. A maintenance dosing regimen has been evaluated as part of the Phase 2b study (Study 201).

Since July 2020 Eisai's 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 and Eisai.

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.

About the collaboration between BioArctic and EisaiSince 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody LEQEMBI back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has right to commercialize lecanemab in the Nordic under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.

About BioArctic ABBioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease-modifying treatments for neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and ALS. BioArctic focuses on innovative treatments in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala University, Sweden. Collaborations with universities are of great importance to the company together with its strategically important global partner Eisai in Alzheimer disease. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential. BioArctic's Class B share is listed on Nasdaq Stockholm Large Cap (ticker: BIOA B). For more information about BioArctic, please visit www.bioarctic.com.

^[1] Phase 3 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 open-label extension study (OLE) is being conducted after the core study. Subcutaneous dosing is currently being evaluated in the Clarity AD OLE.

^[2] 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).

^[3] 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.

^[4] One of the AD pathological features is the accumulation of clusters (plaques) of amyloid beta (A) in the brain. The formation of these plaques is the result of a continuous process by which individual A proteins join together, latching onto each other, one at a time, like adding links to a chain. In the early part of this process these small chains of A are soluble and are toxic to the nerves within the brain. The most toxic of the soluble chains is called a protofibril. Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of A, having a primary role in the cognitive decline associated with this progressive, debilitating condition. Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble A plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.

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