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Gene Therapy: Lexeo Therapeutics’ LX1001 Shows Promise for APOE4-Associated Alzheimer’s Disease

<!DOCTYPE html> <html lang="en"> <head> <meta charset="UTF-8"> <title> Gene Therapy: Lexeo Therapeutics’ LX1001 Shows Promise for APOE4-Associated Alzheimer’s Disease </title> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <link rel="canonical" href="https://www.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/" /> <!-- Google tag (gtag.js) --> <script async src="https://www.googletagmanager.com/gtag/js?id=G-YK7FCK71TD"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'G-YK7FCK71TD'); </script> <meta name="description" content="Lexeo Therapeutics reveals promising interim results for LX1001, a gene therapy aimed at APOE4-linked Alzheimer’s, showcasing dose-dependent APOE2 expression and improved biomarkers." /> <meta name="keywords" content="Lexeo Therapeutics LX1001 APOE4-associated Alzheimer’s gene therapy Alzheimer’s disease treatment APOE2 expression tau biomarkers Clinical Trials on Alzheimer’s Disease (CTAD) Alzheimer’s research neurodegenerative disease therapy clinical trial results CNS gene therapy Alzheimer’s progression amyloid pathology AAVrh10" /> <!-- Twitter Card data --> <meta name="twitter:card" content="summary_large_image"> <meta name="twitter:title" content="Gene Therapy: Lexeo Therapeutics’ LX1001 Shows Promise for APOE4-Associated Alzheimer’s Disease"> <meta name="twitter:description" content="Lexeo Therapeutics reveals promising interim results for LX1001, a gene therapy aimed at APOE4-linked Alzheimer’s, showcasing dose-dependent APOE2 expression and improved biomarkers."> <meta name="twitter:image" content="https://www.biopharmatrend.com"> <!-- Open Graph data --> <meta property="og:type" content="article" /> <meta property="og:url" content="https://www.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/" /> <meta property="og:title" content="Gene Therapy: Lexeo Therapeutics’ LX1001 Shows Promise for APOE4-Associated Alzheimer’s Disease" /> <meta property="og:description" content="Lexeo Therapeutics reveals promising interim results for LX1001, a gene therapy aimed at APOE4-linked Alzheimer’s, showcasing dose-dependent APOE2 expression and improved biomarkers." /> <meta property="article:published_time" content="2024-10-31T16:30:42+00:00"> <meta property="article:modified_time" content="2024-10-31T16:30:42+00:00"> <meta name="author" content="Roman Kasianov"> <meta property="og:image" content="https://www.biopharmatrend.com"> <script type="application/ld+json">{ "@context": "https://schema.org", "@type": "NewsArticle", "headline": "Gene Therapy: Lexeo Therapeutics\u2019 LX1001 Shows Promise for APOE4-Associated Alzheimer\u2019s Disease", "datePublished": "2024-10-31T16:30:42+00:00", "dateModified": "2024-10-31T16:30:42+00:00", "description": "Lexeo Therapeutics\nrecently presented interim findings from its ongoing Phase 1/2 trial of\nLX1001\n, a gene therapy targeting Alzheimer\u2019s disease in patients with two copies of the APOE4 allele, at the Clinical Trials on Alzheimer\u2019s Disease (\nCTAD\n) conference. This allele is associated with a higher risk and faster progression of the disease.", "image": "https://www.biopharmatrend.com", "url": "https://www.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://www.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/" }, "publisher": { "@type": "Organization", "name": "BiopharmaTrend", "url": "https://www.biopharmatrend.com", "logo": { "@type": "ImageObject", "url": "https://www.biopharmatrend.com/static/img/bpt_logo.png" } }, "author": [ { "@type": "Person", "name": "Roman Kasianov", "url": "https://www.biopharmatrend.com/contributor/743/" } ] }</script> <style type="text/css"> .ap-chart-load svg { width: 100%; } .post-meta .author-linkein-icon { width: 1em; vertical-align: baseline; } .text-miniblock { display: inline-block; box-shadow: 0 0 6px -1px forestgreen; 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Digital</a></li> <li><a href="/topic/startups/">Startups &amp; Deals</a></li> <li><a href="/topic/neurotech/">NeuroTech</a></li> <li><a href="/topic/clinical-trials/">Clinical Trials</a></li> <li><a href="/topic/synbio/">Biotech</a></li> <li><a href="/topic/tools-methods/">Tools &amp; Methods</a></li> </ul> </nav> </div> </div> <!-- <header id="main-header" class="brand-block"> <div class="container clearfix"> </div> </header> --> <div id="main-content" class="container"> <main id="content" class="col-lg-9 col-md-8 col-sm-12 col-xs-12"> <div class="mobile-only"> </div> <article id="post-997" class="post "> <header> <h1>Gene Therapy: Lexeo Therapeutics’ LX1001 Shows Promise for APOE4-Associated Alzheimer’s Disease</h1> </header> <footer class="post-meta"> <div class="tooltip"> <span class="glyphicon glyphicon-pencil"></span> by <a href="/contributor/743/">Roman&nbsp;Kasianov</a> </span> &nbsp;&nbsp; <span style="white-space: nowrap;"> <span class="glyphicon glyphicon-folder-open"></span>&nbsp;&nbsp; News </span> <div class="tooltip-text"> <div class="tooltip-close" onclick="this.parentElement.parentElement.classList.toggle('tooltip-show');"></div> <p><b>Disclaimer</b>: All opinions expressed by Contributors are their own and do not represent those of their employers, or BiopharmaTrend.com. <br> Contributors are fully responsible for assuring they own any required copyright for any content they submit to BiopharmaTrend.com. This website and its owners shall not be liable for neither information and content submitted for publication by Contributors, nor its accuracy.</p> </div> </div> <div> <span class="glyphicon glyphicon-calendar" title="Published on"></span> <time datetime="2024-10-31">Oct. 31, 2024</time> &nbsp;&nbsp; </em> </div> <div class="tags"> <b>Topics: </b> <a href="/topic/clinical-trials/">Clinical Trials</a> &nbsp;&nbsp; </div> <div> <strong>Share: </strong> &nbsp; <a target="_blank" rel="nofollow" href="https://www.linkedin.com/sharing/share-offsite/?url=https%3A%2F%2Fwww.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/"> <img alt="Share in LinkedIn" src="/static/img/soc-in.7bc286fd757e.png" width="28" height="28"></a>&nbsp; <a target="_blank" rel="nofollow" href="https://www.reddit.com/submit?url=https%3A%2F%2Fwww.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/"> <img alt="Share in Reddit" src="/static/img/soc-reddit.342e87a07115.png" width="28" height="28"></a>&nbsp; <a target="_blank" rel="nofollow" href="https://twitter.com/intent/tweet?url=https%3A%2F%2Fwww.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/"> <img alt="Share in X" src="/static/img/soc-x.3c80e8291cba.png" width="28" height="28"></a>&nbsp; <a target="_blank" rel="nofollow" href="https://news.ycombinator.com/submitlink?u=https%3A%2F%2Fwww.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/"> <img alt="Share in Hacker News" src="/static/img/soc-y.587f16a5f3f3.png" width="28" height="28"></a>&nbsp; <a target="_blank" rel="nofollow" href="https://www.facebook.com/sharer/sharer.php?u=https%3A%2F%2Fwww.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/&display=page"> <img alt="Share in Facebook" src="/static/img/soc-fb.3031a5a810f0.png" width="28" height="28" /></a>&nbsp; <a target="_blank" rel="nofollow" href="mailto:?subject=Biopharmatrend.com&body=https%3A%2F%2Fwww.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/"> <img alt="Send by email" src="/static/img/soc-mail.41ce3608f438.png" width="28" height="28"></a> &nbsp;&nbsp;|&nbsp;&nbsp;<a href="/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/pdf/" target="_blank" rel="nofollow"> <span style="vertical-align: text-top; color: deepskyblue; font-size: 1.5em;" class="glyphicon glyphicon-print"></span></a> </div> </footer> <section> <p><a href="http://www.lexeotx.com/">Lexeo Therapeutics</a> recently presented interim findings from its ongoing Phase 1/2 trial of <a href="http://www.lexeotx.com/programs/cns-programs/alzheimers/">LX1001</a>, a gene therapy targeting Alzheimer&rsquo;s disease in patients with two copies of the APOE4 allele, at the Clinical Trials on Alzheimer&rsquo;s Disease (<a href="http://www.ctad-alzheimer.com/">CTAD</a>) conference. This allele is associated with a higher risk and faster progression of the disease.</p> <p><strong>Detailed Findings: Dose-Dependent APOE2 Expression and Biomarker Changes</strong></p> <p>LX1001 is designed to deliver the APOE2 gene into the central nervous system (CNS) of APOE4 homozygous patients, who otherwise produce only the APOE4 protein, linked to increased Alzheimer&rsquo;s risk. The study included 15 patients across four dose cohorts, all with either mild cognitive impairment or mild-to-moderate Alzheimer&rsquo;s. Findings reveal that:</p> <ul> <li><strong>APOE2 Protein Expression:</strong> All participants showed increases in APOE2 protein in cerebrospinal fluid (CSF) that were both dose- and time-dependent, with durability observed out to 12 months in earlier cohorts.</li> <li><strong>Tau Reduction:</strong> Key Alzheimer&rsquo;s-related tau biomarkers, including CSF T-tau, P-tau181, P-tau217, and P-tau231, saw reductions in over two-thirds of participants when compared to baseline. Reductions in tau PET signal were observed at 6 months in 5 out of 6 participants evaluated.</li> <li><strong>Amyloid Stability:</strong> The study showed minimal change in amyloid biomarkers (A&szlig;42/40 ratio and amyloid PET imaging) across participants, indicating stabilization of amyloid pathology.</li> </ul> <blockquote> <p>See also: <a href="https://www.biopharmatrend.com/post/401-ups-and-downs-of-adenovirus-and-adeno-associated-virus-vectors-in-gene-therapy/">Ups and Downs of Adenovirus and Adeno-Associated Virus Vectors in Gene Therapy</a></p> </blockquote> <p><strong>Safety Profile</strong></p> <p>LX1001 has demonstrated a favorable safety profile, with no reports of amyloid-related imaging abnormalities (ARIA), a concern in other Alzheimer&rsquo;s treatments, particularly in APOE4 carriers. While four serious adverse events were noted, only one, mild-to-moderate sensorineural hearing loss, was possibly related to treatment and is under further review.</p> <p><strong>Patient Outcomes and Next Steps</strong></p> <ul> <li><strong>Best Responses in Moderate AD Participants:</strong> The patients with moderate Alzheimer&rsquo;s disease (n=4) generally showed the strongest biomarker responses across tau and amyloid measures, hinting at a dose-response relationship.</li> </ul> <p>Lexeo is now in discussions with the FDA regarding these initial results and anticipates sharing updates in 2025 as they continue with further cohort analysis and follow-ups. These findings contribute to the growing evidence on the potential of LX1001 as a gene therapy that may shift the underlying mechanisms of Alzheimer&rsquo;s in high-risk populations.</p> <p>Clinical trial: <a href="https://clinicaltrials.gov/study/NCT03634007">Gene Therapy for APOE4 Homozygote of Alzheimer&#39;s Disease</a></p> <div class="product-list"> </div> <p> <b>Topics: </b> <a href="/topic/clinical-trials/">Clinical Trials</a> &nbsp;&nbsp; </p> </section> </article> <div style="margin: 1em 0 2em; padding: 0.5em 0;"> <strong>Share: </strong> &nbsp; <a target="_blank" rel="nofollow" href="https://www.linkedin.com/sharing/share-offsite/?url=https%3A%2F%2Fwww.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/"> <img alt="Share in LinkedIn" src="/static/img/soc-in.7bc286fd757e.png" width="28" height="28"></a>&nbsp; <a target="_blank" rel="nofollow" href="https://www.reddit.com/submit?url=https%3A%2F%2Fwww.biopharmatrend.com/post/997-gene-therapy-lexeo-therapeutics-lx1001-shows-promise-for-apoe4-associated-alzheimers-disease/"> <img alt="Share in Reddit" src="/static/img/soc-reddit.342e87a07115.png" width="28" height="28"></a>&nbsp; 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