Eluminex Begins Phase 1b LOTUS Trial of EB-105 for Diabetic Macular Edema

Eluminex Biosciences, a clinical-stage biotechnology firm specializing in advanced protein therapeutics for vision-threatening conditions, has announced the first administration of EB-105 to patients with diabetic macular edema (DME) as part of the LOTUS study. EB-105 is noteworthy as the first pentavalent trispecific antibody that targets five different molecules: VEGF-A, VEGF-B, PlGF, Ang-2, and IL-6R. The LOTUS study marks the initial clinical evaluation of this novel therapy and is being conducted at four centers in the United States.

The LOTUS trial is designed as an open-label, multicenter, single injection, dose-escalation study. The primary goal is to evaluate the safety, tolerability, and pharmacodynamics of EB-105 in patients with center-involved DME. Approximately 12 patients will be enrolled, with around four patients receiving each of the three escalating doses. Imaging and visual acuity assessments will be used to measure pharmacodynamics, and the study aims to identify the two optimal doses for a subsequent repeat injection study anticipated in 2025. Topline data from this single injection study is expected in the first half of 2025.

EB-105 has shown significant efficacy in preclinical studies, effectively inhibiting VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R signaling pathways. IL-6 is an inflammatory cytokine that plays a crucial role in endothelial cell barrier dysfunction, which leads to vascular leakage—a common issue in retinal diseases such as DME, diabetic retinopathy, neovascular age-related macular degeneration, and retinal vein occlusion.

Dr. Ashkan Abbey, the Director of Clinical Research at Texas Retina Associates, was the first retinal surgeon to administer EB-105 in a clinical setting. He emphasized the importance of introducing IL-6 pathway inhibition for managing difficult-to-treat patients. "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 noted.

Eluminex's Chief Medical Officer, Charles Semba, MD, highlighted the significance of EB-105 in the evolving field of polyvalent protein engineering. "EB-105 represents a significant advance in the rapidly emerging science of polyvalent protein engineering," he stated. "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."

The LOTUS trial involves several leading retinal surgeons, including Dr. Carl Awh from Tennessee Retina in Nashville, Dr. Veeral Sheth from University Retina in Lemont, and Dr. Charles Wyckoff from Retina Consultants of Houston. The study is being coordinated by Vial, Inc., a clinical research organization based in San Francisco.

Eluminex Biosciences was founded in early 2020 and is headquartered in Suzhou Industrial Park BioBAY, China. The company also operates a research and development center and Good Manufacturing Practices (GMP) manufacturing facilities at the same location. Their US regional office is situated in Mountain View, California. Eluminex has garnered substantial financial support from prominent venture groups including Lilly Asia Ventures, Quan Capital, Hillhouse BioVenture, Cenova Capital, and 3E BioVentures. The company has raised over $100 million through Series B+ financing.

This development signifies a promising step forward in the treatment of vision-threatening conditions, potentially offering new hope to patients suffering from complex retinal diseases.