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New LEQEMBI CompanionTM program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more LEQEMBI IQLIK, approved by the U.S. FDA in August 2025, is the first and only anti-amyloid treatment to offer an at-home injection after initial treatment of 18 months TOKYO and CAMBRIDGE, Mass., Oct. 6, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIKTM) is now available in the U.S. as a maintenance dosing regimen for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). After 18 months of LEQEMBI (lecanemab-irmb) intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector. Continue Reading LEQEMBI IQLIK product photo Eisai and Biogen have also launched the LEQEMBI CompanionTM program, an initiative rooted in both companies' commitment to providing access to LEQEMBI and resources for people living with early Alzheimer's disease. The program aims to provide expanded resources that support patients throughout their LEQEMBI treatment journey, from initiation through maintenance therapy. In addition to the current resources already provided (e.g., help with understanding insurance coverage and potential out-of-pocket costs and identifying financial support programs), the new LEQEMBI Companion program will now offer patients: Injection education through Nurse Educators either in-person or virtually to provide patients with training on injecting their maintenance dose using the LEQEMBI IQLIK (nurse educators train on the device only; patients should discuss any treatment-related questions with their doctor). A welcome kit that includes educational resources to help patients and care partners know what to expect, prepare for at-home injections, and more. Designed to serve as a digital solution to help support patients and care partners along their treatment journey, the LEQEMBI Companion app was developed with Medisafe, a digital patient engagement and medication management platform. From educational information about the injection process to a tool for tracking where and when injections occur, the LEQEMBI Companion app offers resources and more all in one place. Patients can visit LEQEMBI.com/CompanionAppSignUp to get started. To further support access to LEQEMBI for certain patients who need help paying for their medicines, Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured and underinsured patients, who meet financial need and other program criteria. To learn more, or if you are already enrolled and have questions, visit LEQEMBI.com/PatientSupport or call 1-833-4-LEQEMBI (1-833-453-7362), Monday-Friday, 8 a.m. to 8 p.m. Eastern Time. AD is a progressive, relentless disease characterized by formation of protein deposits known as plaques made of amyloid-beta aggregates and neurofibrillary tangles made of tau protein in the brains of people living with AD. It is caused by a continuous underlying neurotoxic process that begins before amyloid plaque accumulation and continues after plaque removal.1-3 The data show that amyloid-beta protofibrils and tau tangles play roles in the neurodegeneration process,4-6 and only LEQEMBI fights AD in two ways – targeting both amyloid plaque and protofibrils*, which can impact tau downstream. Due to the reaccumulation of AD biomarkers and return to placebo rate of decline after therapy is stopped,4-5 continuing maintenance treatment after the initial 18-month therapy is essential to slow the progression of AD and extend the therapeutic benefits, helping patients maintain who they are for longer. The availability of LEQEMBI IQLIK in the U.S. offers patients and care partners the ability to use the device at home, shortening treatment time, and providing an option to continue treatment without having to worry about visiting an infusion center. The LEQEMBI IQLIK also has the potential to reduce healthcare resources associated with IV maintenance dosing, such as preparation for infusion and nurse monitoring, while increasing infusion capacity for new eligible patients to begin initiation treatment and streamlining the overall AD treatment pathway. Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. * Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.6 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.5 INDICATION LEQEMBI® is indicated for the treatment of Alzheimer's disease (AD). 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. IMPORTANT SAFETY INFORMATION C ONTRAINDICATION Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis. WARNINGS AND PRECAUTIONS AMYLOID-RELATED IMAGING ABNORMALITIES Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time. Incidence of ARIA Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo. Incidence of ICH ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed. Risk Factors of ARIA and ICH ApoE ε4 Carrier Status Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers. Radiographic Findings of CAA Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE ε4 allele is also associated with CAA. The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH. Concomitant Antithrombotic or Thrombolytic Medication In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo. Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent. Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI. Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA. Radiographic Severity With LEQEMBI Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%). Monitoring and Dose Management Guidelines Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment. HYPERSENSITIVITY REACTIONS Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. 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 (IRR s) IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation. IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids. ADVERSE REACTIONS The most common adverse reactions reported in ≥5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%) Safety profile of LEQEMBI IQLIK for maintenance treatment was similar to LEQEMBI infusion. Patients who received LEQEMBI IQLIK experienced localized and systemic (less frequent) injection-related reactions (mild to moderate in severity) LEQEMBI (lecanemab-irmb) is available: Intravenous infusion: 100 mg/mL Subcutaneous injection: 200 mg/mL Please see full Prescribing Information for LEQEMBI, including Boxed WARNING. Notes to Editors 1. About lecanemab (generic name, brand name: LEQEMBI ® ) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab has been approved in 50 countries and is under regulatory review in 8 countries. In January 2025, the supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing of the treatment was approved in the U.S., and application have been filed in nine (9) countries and regions. LEQEMBI's approvals in these countries was based on Phase 3 data from Eisai's, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo (difference, −0.45; 95% confidence interval [CI], −0.67 to −0.23; P<0.001). In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted a statistically significant benefit of 37% compared to placebo. The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was −3.5 in the lecanemab group and −5.5 in the placebo group (difference, 2.0; 95% CI, 1.2 to 2.8; P<0.001). The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall. The subcutaneous maintenance dosing approval is based on LEQEMBI subcutaneous (SC) sub-studies of the Phase 3 Clarity AD open-label extension (OLE) trial in individuals with early AD which evaluated a range of subcutaneous doses. Data shows that transitioning to the weekly LEQEMBI IQLIK autoinjector after 18 months of the initiation dose (10 mg/kg IV every two weeks) maintains clinical and biomarker benefits comparable to continued IV dosing. The safety of LEQEMBI IQLIK autoinjector was studied in over 600 patients at a range of doses as part of the Clarity AD OLE. Across all subcutaneous doses, the safety profile was similar to that of the IV maintenance treatment with one key difference: systemic reactions were much less common with subcutaneous dosing—less than 1% compared to approximately 26% with IV infusions. ARIA rates in patients who received a weekly 360 mg subcutaneous maintenance dose were similar to ARIA rates reported in patients who continued with the IV dose after 18 months and are similar to the background rates of ARIA in patients without treatment. 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 lecanemab 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 lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab 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 (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit and Eisai EMEA LinkedIn. 5. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. The company routinely posts information that may be important to investors on its website at . Follow Biogen on social media – Facebook, LinkedIn, X, YouTube. Biogen Safe Harbor This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); 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 lecanemab; and risks and uncertainties associated with drug development and commercialization. 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Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned "Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. References LEQEMBI (lecanemab-irmb) injection, for intravenous use [package insert]. Nutley, NJ: Eisai Inc. Iwatsubo T, Irizarry M, van Dyck C, Sabbagh M, Bateman RJ, Cohen S. Clarity AD: a phase 3 placebo-controlled, double-blind, parallel-group, 18-month study evaluating lecanemab in early Alzheimer's disease. Presented at: CTAD Conference; November 29-December 2, 2022; San Francisco, CA. Hampel H, Hardy J, Blennow K, et al. The amyloid-? pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z Ono K, Tsuji M. Protofibrils of Amyloid-β 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. Morris JC. Neurology. 1993;43(11):2412-4. SOURCE Eisai Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Lyon & Caen, France, September 22, 2025 – Lys Therapeutics, a French biotechnology company pioneering an innovative approach targeting the blood-brain barrier (BBB) to treat neurodegenerative and neurovascular diseases, today announces the renewed support and the grant award of USD $5 million from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to accelerate the clinical development of LYS241, its first-in-class monoclonal antibody for the treatment of Parkinson’s disease and other neurodegenerative disorders. This significant new funding, part of MJFF’s Therapeutic Pipeline Program, will support the completion of preclinical development and the launch of first-in-human clinical trials, marking a major milestone in Lys Therapeutics’ mission to bring transformative treatments to patients suffering from neurological diseases. “We are honored by the continued trust of The Michael J. Fox Foundation. This grant is both a strong validation of the science behind LYS241 and a powerful catalyst for our development program. It enables us to move with confidence toward clinical evaluation, with the goal of offering patients a truly novel therapeutic option.” said Dr. Manuel Blanc, CEO and co-founder of Lys Therapeutics. LYS241 is a monoclonal antibody designed to neutralize the pathological mechanisms associated with BBB dysfunction, a central process in many neurological diseases. Impairment of the BBB promotes the entry of toxic molecules and inflammatory cells into the central nervous system, leading to neuroinflammation, excitotoxicity, and neuronal death. Specifically, LYS241 is designed to block the interaction between tissue plasminogen activator (tPA) and the NMDA receptor (NMDAr) in the vascular compartment — a key driver of BBB dysfunction, neuroinflammation, and dopaminergic neuron degeneration in Parkinson’s disease. Unlike conventional therapeutic approaches that must cross the BBB to reach their target, LYS241 works from within the blood vessels. By restoring vascular NMDA receptor function, it re-establishes BBB integrity, halts the infiltration of harmful immune cells into the brain, and interrupts a cascade of events leading to neurodegeneration, a hallmark of disease progression in Parkinson’s and other neurological disorders. This approach tackles a fundamental cause of disease progression instead of limiting treatment to symptom control. “Our collaborative work with Lys Therapeutics and INSERM in France has shown that the tPA–NMDAr interaction plays a central role in Parkinson’s pathology. By blocking this mechanism, LYS241 targets a root cause of disease progression rather than simply managing symptoms — representing a true paradigm shift,” said Prof. Daniel A. Lawrence, Department of Internal Medicine and Department of Molecular & Integrative Physiology at the University of Michigan, USA. The MJFF award comes as Lys Therapeutics advances its “pipeline-in-a-drug” strategy — developing LYS241 for multiple neurological diseases driven by BBB dysfunction and neuroinflammation. Beyond Parkinson’s disease, LYS241 has demonstrated potent disease-modifying effects in validated preclinical models of multiple system atrophy, ischemic stroke, and multiple sclerosis, underscoring its multi-indication potential and transformative impact. These findings have been featured in peer-reviewed publications, showcased at major international scientific congresses, and recognized with substantial non-dilutive funding, including previous MJFF support, competitive public grants, and private investment. Following the positive Scientific Advice from national drug agencies, Lys Therapeutics is now accelerating its regulatory studies to complete its dossier in preparation for clinical trial initiation. The company is fully financed to progress through early-stage clinical development, strengthened by this MJFF grant and a significant equity capital increase in 2024. “The Michael J. Fox Foundation continues its pursuit toward our singular and urgent mission of delivering improved therapies and a cure for patients living with Parkinson’s disease,” said Dr. Jessica Tome Garcia, MJFF’s lead scientific program manager. “This work with Lys Therapeutics on a novel approach targeting neuroinflammation is an example of the field’s robust pipeline of new class treatments that goes beyond symptom management by targeting the underlying disease biology.” About Parkinson’s Disease Parkinson’s disease is a progressive neurodegenerative disorder affecting more than 10 million people worldwide. It is characterized by motor symptoms (tremor, bradykinesia, rigidity) and non-motor complications (cognitive decline, sleep disorders, mood disturbances). Despite available treatments, there is currently no cure or approved disease-modifying therapy. About LYS241 LYS241 is a fully humanized IgG1 monoclonal antibody with an Fc-silent backbone, designed to neutralize key pathological mechanisms underlying blood-brain barrier dysfunction—a central driver of many neurological disorders. When the BBB is compromised, toxic molecules and inflammatory cells can infiltrate the central nervous system, triggering neuroinflammation, excitotoxicity, and ultimately neuronal death. By restoring BBB integrity and protecting brain tissue, LYS241 addresses both acute and chronic neurological conditions, truly embodying a pipeline-in-a-drug. Its mechanism of action offers therapeutic benefits across multiple indications: in ischemic stroke, whether administered alone or alongside standard thrombolytic agents (alteplase or tenecteplase), LYS241 counteracts tPA-induced vascular injury, preserves BBB integrity, enhances reperfusion, and reduces the risk of hemorrhage and inflammation; in neurodegenerative diseases such as Parkinson’s disease, multiple sclerosis, and other severe inflammatory disorders, it holds strong potential to slow or halt disease progression. Lys Therapeutics is advancing an ambitious clinical development program to fully unlock the broad therapeutic potential of LYS241. About Lys Therapeutics First-in-class biotherapies against neurological diseases. Lys Therapeutics is a biotechnology company developing first-in-class monoclonal antibodies to treat patients suffering from neurodegenerative and neurovascular diseases with high unmet medical needs. Its lead candidate, LYS241, is a vascular-targeting immunotherapy with a unique mode of action restoring BBB integrity by blocking the pathological interaction between tPA and vascular NMDA receptors. This mechanism is central to the pathogenesis of several major neurological disorders, including Parkinson’s disease, ischemic stroke, and multiple sclerosis. With operations in Lyon and Caen (France), and strategic collaborations with international research institutions, Lys Therapeutics is advancing a robust and versatile pipeline, supported by prestigious funding partners including The Michael J. Fox Foundation, Bpifrance, and private investors. Lys Therapeutics’ approach of targeting neuroinflammation to combat neurodegeneration represents a promising avenue in the search for effective treatments for these debilitating disorders. More information on lystherapeutics.com