{"id":37180,"date":"2025-06-09T16:00:00","date_gmt":"2025-06-09T16:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4705622_CN05622_0"},"modified":"2025-06-09T16:00:00","modified_gmt":"2025-06-09T16:00:00","slug":"eluminex-biosciences-announces-phase-1b-single-ascending-dose-study-results-of-a-novel-pentavalent-trispecific-fusion-antibody-eb-105-in-patients-with-diabetic-macular-edema-dme","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=37180","title":{"rendered":"Eluminex Biosciences Announces Phase 1b Single Ascending Dose Study Results of a Novel Pentavalent Trispecific Fusion Antibody (EB-105) in Patients with Diabetic Macular Edema (DME)"},"content":{"rendered":"<ul type=\"disc\">\n<li><i>EB-105 Targets VEGF-A, -B, PlGF, Ang-2, and IL-6R<\/i><\/li>\n<li><i>Improvements in Visual Acuity and Retinal Edema Observed at All Dose Levels<\/i><\/li>\n<li><i>No Safety Issues Observed Following a Single Intravitreal (IVT) Injection<\/i><\/li>\n<li><i>Multiple Ascending Dose Study Planned for Q3 2025 in DME<\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">MOUNTAIN VIEW, Calif.<\/span>, June 10, 2025 \/PRNewswire\/ &#8212; Eluminex Biosciences Limited, a clinical-stage protein therapeutics company announced positive topline safety, tolerability, and pharmacodynamic data from a first-in-human single ascending dose study evaluating EB-105 in patients with vision-threatening DME (<i>LOTUS<\/i> study, Part 1). The study results will be presented at the Clinical Trials at the Summit annual meeting in <span class=\"xn-location\">Las Vegas, NV<\/span> on <span class=\"xn-chron\">June 21, 2025<\/span>, by retinal specialist <span class=\"xn-person\">Veeral Sheth<\/span>, MD, Clinical Asst. Professor of Ophthalmology, <span class=\"xn-org\">University of Illinois<\/span>, and an investigator in the study.<\/span><\/p>\n<p>The <i>LOTUS<\/i> study (Part 1) was an open-label, multicenter, ascending dose study that evaluated a single IVT injection of EB-105 at low (1.6 mg\/eye, N=4), mid (4.0 mg\/eye, N=5), and high (8.0 mg\/eye, N=4) doses in all-comer DME patients (N=13) enrolled from four clinical sites in <span class=\"xn-location\">the United States<\/span>. Subjects received EB-105 on Day 1 and followed for 3 months. There were no reported drug-related adverse events, dose-limiting toxicities, or serious adverse events including ocular inflammation. The study demonstrated clinically relevant pharmacodynamic activities in all dose groups with sustained overall mean improvement in best-corrected visual acuity (BCVA) and reduction in central retinal subfield thickness (CST). At Month 3 after a single injection of EB-105, maximal reductions in CST from baseline of -103 to -429 mm with maximal gains in BCVA from baseline of +12 to +21 letters were observed across the three dose levels.<\/p>\n<p>&#8220;EB-105 has the potential to represent a new generation of tri-specific antibody therapeutics that will allow retinal specialists to treat a broad range of retinal diseases beyond DME in which IL-6-mediated inflammation plays a role including neovascular age-related macular degeneration, retinal vein occlusion, and uveitic macular edema,&#8221; said Dr. Sheth. Preparations are underway for Part 2 of the&nbsp;<i>LOTUS<\/i> study that will assess multiple IVT injections in patients with DME. &#8220;We are highly encouraged by the initial safety and sustained pharmacodynamic benefits observed in visual acuity improvements and retinal edema reduction following a single injection. Our hope is that multiple injections will provide even further clinical benefits with the added possibility to treat non-responders and increase dosing durability well-beyond the current 16-week benchmark by addressing unchecked IL-6 mediated inflammation<span id=\"spanHghlt961b\">,<\/span>&#8221; commented <span class=\"xn-person\">Wei Yong Shen<\/span>, MD, PhD, Chief Scientific Officer of Eluminex Biosciences.<\/p>\n<p><b>About the <i>LOTUS<\/i> Trial<\/b><\/p>\n<p><i>LOTUS<\/i>&nbsp;is a multicenter study being conducted in <span class=\"xn-location\">the United States<\/span>. Part 1 of the study was a single ascending dose study in patients with DME. Part 1 was conducted at five centers in <span class=\"xn-location\">the United States<\/span>. In addition to participation by Dr. Sheth were the following leading retinal surgeon investigators:&nbsp;Ashkan Abbey, MD, <span class=\"xn-location\">Dallas, TX<\/span>; <span class=\"xn-person\">David Almeida<\/span>, MD, <span class=\"xn-location\">Erie, PA<\/span>; <span class=\"xn-person\">Carl Awh<\/span>, MD, <span class=\"xn-location\">Nashville<\/span>, TN;&nbsp;and <span class=\"xn-person\">Charles Wyckoff<\/span>, MD, <span class=\"xn-location\">Houston<\/span>, TX.&nbsp;The <i>LOTUS<\/i> Part 2 study will be conducted with multiple ascending doses (\u2265 3 monthly IVT injections) in a similar DME population evaluating the same three dose levels as assessed in Part 1 and will be conducted at up to 10 sites in <span class=\"xn-location\">the United States<\/span>. The primary objectives of Part 2 will be safety, tolerability and pharmacodynamics and to potentially select a single dose level for Phase 2\/3 studies in the future.&nbsp; The study is anticipated to begin enrollment in Q3 2025.<\/p>\n<p><b>About Eluminex Biosciences<\/b><\/p>\n<p>Eluminex was founded in early 2020. The company headquarters, research and development (R&amp;D) center, and Good Manufacturing Practices (GMP) manufacturing facilities for recombinant human collagen-based aesthetic products are located in Suzhou Industrial Park BioBAY,&nbsp;China, and the US regional office is located in&nbsp;Mountain View, <span class=\"xn-location\">California<\/span>. For more information, refer to <a href=\"http:\/\/www.eluminexbio.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.eluminexbio.com<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EB-105 Targets VEGF-A, -B, PlGF, Ang-2, and IL-6R Improvements in Visual Acuity and Retinal Edema Observed at All Dose Levels No Safety Issues Observed Following a Single Intravitreal (IVT) Injection Multiple Ascending Dose Study Planned for Q3 2025 in DME MOUNTAIN VIEW, Calif., June 10, 2025 \/PRNewswire\/ &#8212; Eluminex Biosciences Limited, a clinical-stage protein therapeutics [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-37180","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Eluminex Biosciences Announces Phase 1b Single Ascending Dose Study Results of a Novel Pentavalent Trispecific Fusion Antibody (EB-105) in Patients with Diabetic Macular Edema (DME) - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=37180\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eluminex Biosciences Announces Phase 1b Single Ascending Dose Study Results of a Novel Pentavalent Trispecific Fusion Antibody (EB-105) in Patients with Diabetic Macular Edema (DME) - My Blog\" \/>\n<meta property=\"og:description\" content=\"EB-105 Targets VEGF-A, -B, PlGF, Ang-2, and IL-6R Improvements in Visual Acuity and Retinal Edema Observed at All Dose Levels No Safety Issues Observed Following a Single Intravitreal (IVT) Injection Multiple Ascending Dose Study Planned for Q3 2025 in DME MOUNTAIN VIEW, Calif., June 10, 2025 \/PRNewswire\/ &#8212; Eluminex Biosciences Limited, a clinical-stage protein therapeutics [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/transmediavictoria.net.au\/?p=37180\" \/>\n<meta property=\"og:site_name\" content=\"My Blog\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-09T16:00:00+00:00\" \/>\n<meta name=\"author\" content=\"admin_tony\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin_tony\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=37180#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=37180\"},\"author\":{\"name\":\"admin_tony\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\"},\"headline\":\"Eluminex Biosciences Announces Phase 1b Single Ascending Dose Study Results of a Novel Pentavalent Trispecific Fusion Antibody (EB-105) in Patients with Diabetic Macular Edema (DME)\",\"datePublished\":\"2025-06-09T16:00:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=37180\"},\"wordCount\":639,\"articleSection\":[\"Business News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=37180\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=37180\",\"name\":\"Eluminex Biosciences Announces Phase 1b Single Ascending Dose Study Results of a Novel Pentavalent Trispecific Fusion Antibody (EB-105) in Patients with Diabetic Macular Edema (DME) - 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