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GLP-1

典晶生物宣布其在美国进行的首个EB-105 临床试验圆满结束

典晶生物

06/11

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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 9, 2025 /PRNewswire/ -- 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 (LOTUS study, Part 1). The study results will be presented at the Clinical Trials at the Summit annual meeting in Las Vegas, NV on June 21, 2025, by retinal specialist Veeral Sheth, MD, Clinical Asst. Professor of Ophthalmology, University of Illinois, and an investigator in the study.

The LOTUS 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 the United States. 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 µm with maximal gains in BCVA from baseline of +12 to +21 letters were observed across the three dose levels.

"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," said Dr. Sheth. Preparations are underway for Part 2 of the LOTUS study that will assess multiple IVT injections in patients with DME. "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," commented Wei Yong Shen, MD, PhD, Chief Scientific Officer of Eluminex Biosciences.

▍About the LOTUS Trial

LOTUS is a multicenter study being conducted in the United States. Part 1 of the study was a single ascending dose study in patients with DME. Part 1 was conducted at five centers in the United States. In addition to participation by Dr. Sheth were the following leading retinal surgeon investigators: Ashkan Abbey, MD, Dallas, TX; David Almeida, MD, Erie, PA; Carl Awh, MD, Nashville, TN; and Charles Wyckoff, MD, Houston, TX. The LOTUS Part 2 study will be conducted with multiple ascending doses (≥ 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 the United States. 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. The study is anticipated to begin enrollment in Q3 2025.

▍About Eluminex Biosciences

Eluminex was founded in early 2020. The company headquarters, research and development (R&D) center, and Good Manufacturing Practices (GMP) manufacturing facilities for recombinant human collagen-based aesthetic products are located in Suzhou Industrial Park BioBAY,China, and the US regional office is located in Mountain View, California. For more information, refer to www.eluminexbio.com.

▍Contact for Investors/Media:

info@eluminexbio.com

▲如需转载，请注明来源——典晶生物。