Eluminex Biosciences Announces First Patient Dosed in the Phase 1b LOTUS Trial of the Novel Trispecific Fusion Antibody EB-105 in Diabetic Macular Edema (DME)

News provided by

Jul 15, 2024, 11:00 ET

EB-105 is the world's first pentavalent trispecific antibody targeting VEGF-A, VEGF-B, PlGF, Ang-2 and IL-6R in DME
LOTUS study is the initial clinical trial of Eluminex's EB-105 being conducted in the United States

SAN FRANCISCO and SUZHOU, China, July 15, 2024 /PRNewswire/ -- Eluminex Biosciences (Eluminex), a clinical stage, privately held biotechnology company focused on the development of advanced protein therapeutics for vision-threatening diseases announced the first dosing of EB-105 in patients with DME. The LOTUS trial is a first-in-human, open-label, multicenter, single injection, dose-escalation study of EB-105, Eluminex's lead ophthalmology asset being conducted at four sites in the United States. EB-105 has been shown in preclinical studies to potently inhibit VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R signaling. Vitreous levels of IL-6, an inflammatory cytokine known to play a role in endothelial cell barrier dysfunction leading to vascular leakage, are elevated in patients with retinal disease including DME, diabetic retinopathy, neovascular (wet) age-related macular degeneration, and retinal vein occlusion.

Dr. Ashkan Abbey, MD, Director of Clinical Research at Texas Retina Associates was the first retinal surgeon in the world to administer EB-105 treatment in the clinic. "Retina specialists welcome the addition of IL-6 pathway inhibition. We are in need of newer agents for these often difficult to manage patients. It is our hope that EB-105 will translate into incremental improvements in visual acuity, durability of response, and improved drying of the retina," he commented. "EB-105 represents a significant advance in the rapidly emerging science of polyvalent protein engineering," stated Charles Semba, MD, Eluminex's Chief Medical Officer. "For patients, it offers the promise of broader coverage of known biologic pathways associated with diabetic retinopathy and potentially better outcomes beyond currently available therapies," he added.

About the LOTUS Trial

LOTUS is a multicenter, single intravitreal (IVT) injection dose escalation study that will evaluate three dose levels of EB-105 in patients with center-involved diabetic macular edema and will enroll approximately 12 patients (4 per dose level). The primary objectives are safety, tolerability and pharmacodynamics (as assessed by imaging and visual acuity assessments) and to select the two best doses for a separate repeat injection study that is anticipated in 2025. Topline data from the current single injection study is anticipated in 1H 2025. In addition to Dr. Abbey are the following leading retinal surgeon investigators: Carl Awh, MD, Tennessee Retina, Nashville, TN; Veeral Sheth, MD, University Retina, Lemont, IL, and Charles Wyckoff, MD, Retina Consultants of Houston, Houston, TX. The study is being facilitated by the clinical research organization (CRO) Vial, Inc., based in San Francisco, CA.

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 are located in Suzhou Industrial Park BioBAY, China, and the US regional office is located in Mountain View, California. Eluminex is currently supported by leading venture groups including Lilly Asia Ventures, Quan Capital, Hillhouse BioVenture, Cenova Capital, and 3E BioVentures and has raised over $100M (USD) through Series B+ financing. For more information: www.eluminexbio.com.

SOURCE Eluminex Biosciences