Eluminex Biosciences Limited has reported positive topline results from its first-in-human Phase 1b single ascending dose study of EB-105, a novel pentavalent trispecific fusion antibody designed to treat diabetic macular edema (DME). The LOTUS study demonstrated clinically relevant improvements in visual acuity and retinal edema reduction across all dose levels, with no safety concerns following a single intravitreal injection.
Study Design and Patient Population
The LOTUS Part 1 study was an open-label, multicenter, ascending dose trial that enrolled 13 all-comer DME patients from four clinical sites in the United States. Participants received a single intravitreal injection of EB-105 at three dose levels: low (1.6 mg/eye, N=4), mid (4.0 mg/eye, N=5), and high (8.0 mg/eye, N=4). Subjects were followed for three months post-injection to assess safety, tolerability, and pharmacodynamic activity.
Mechanism of Action and Clinical Outcomes
EB-105 represents a new generation of trispecific antibody therapeutics that simultaneously targets five key components involved in retinal diseases: VEGF-A, VEGF-B, PlGF, Ang-2, and IL-6R. This comprehensive targeting approach addresses multiple pathways contributing to DME pathogenesis.
The study demonstrated sustained overall mean improvement in best-corrected visual acuity (BCVA) and reduction in central retinal subfield thickness (CST) across all dose groups. At Month 3 following a single injection, maximal reductions in CST from baseline ranged from -103 to -429 mm, while maximal gains in BCVA from baseline reached +12 to +21 letters across the three dose levels.
Safety Profile
The study reported no drug-related adverse events, dose-limiting toxicities, or serious adverse events, including ocular inflammation. This favorable safety profile supports the continued development of EB-105 for retinal diseases.
Expert Commentary and Broader Therapeutic Potential
Dr. Veeral Sheth, a retinal specialist and Clinical Assistant Professor of Ophthalmology at the University of Illinois who served as an investigator in the study, highlighted the broader therapeutic potential of EB-105. "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," Dr. Sheth stated.
Future Development Plans
Wei Yong Shen, MD, PhD, Chief Scientific Officer of Eluminex Biosciences, expressed optimism about the initial results and outlined the company's development strategy. "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," Dr. Shen commented.
The company is preparing for Part 2 of the LOTUS study, which will evaluate multiple ascending doses with a minimum of three monthly intravitreal injections in DME patients. This phase will be conducted at up to 10 sites in the United States and is anticipated to begin enrollment in Q3 2025. The primary objectives of Part 2 include assessing safety, tolerability, and pharmacodynamics, with the goal of potentially selecting a single dose level for future Phase 2/3 studies.
Company Background
Founded in early 2020, Eluminex Biosciences Limited is a clinical-stage protein therapeutics company dedicated to developing innovative treatments for ophthalmic diseases. The company operates research and development facilities and Good Manufacturing Practices (GMP) facilities in Suzhou Industrial Park, China, while maintaining an office in Mountain View, California.
