Chinese clinical-stage protein therapeutics company Eluminex Biosciences Limited on Monday reported positive topline safety, tolerability, and pharmacodynamic data from a first-in-human single ascending dose study evaluating EB-105 in patients with vision-threatening diabetic macular edema (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 21 June 2025 by retinal specialist Veeral Sheth, MD, clinical assistant professor of Ophthalmology, University of Illinois, and an investigator in the study.

The LOTUS study Part 1 was an open-label, multicentre, 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 were followed for 3 months. The company says that 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.

The LOTUS Part 2 study will be conducted with multiple ascending doses (3 or more 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. Primary objectives 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 enrolment in Q3 2025.