Chinese biotechnology company Eluminex Biosciences has dosed the first patient with its trispecific fusion antibody, EB-105, in the Phase I LOTUS trial for the treatment of diabetic macular oedema (DME).
The first-in-human, open-label trial is being conducted across four sites in the US and involves a single injection and dose-escalation of EB-105.
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Eluminex chief medical officer Charles Semba said: “EB-105 represents a significant advance in the rapidly emerging science of polyvalent protein engineering.
“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.”
EB-105 has demonstrated potent inhibition of VEGF-A/VEGFR-2, Ang-2/Tie-2 and IL-6/IL-6R signalling pathways in preclinical studies.
These pathways are critical to the development of retinal diseases, with increased vitreous levels of inflammatory cytokine IL-6 being associated with vascular leakage in conditions such as diabetic retinopathy, DME and neovascular age-related macular degeneration.
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By GlobalDataThe LOTUS trial aims to evaluate the safety, tolerability and pharmacodynamics of three dose levels of EB-105 in patients with centre-involved DME.
Approximately 12 patients are planned to be enrolled, with four patients for each dose level.
The trial’s primary goal is to determine the optimal doses for a subsequent repeat injection study, which is due to be carried out next year.
Eluminex anticipates topline data from the current single injection study in the first half of next year.
The study’s team of retinal surgeon investigators includes Carl Awh from Tennessee Retina in Nashville, Tennessee; Veeral Sheth from University Retina in Lemont, Illinois; and Charles Wyckoff from Retina Consultants of Houston, Texas.
Clinical research organisation Vial is facilitating the trial.
Based in Suzhou, Eluminex is a biotechnology company supported by Lilly Asia Ventures, Quan Capital, Hillhouse BioVenture, Cenova Capital and 3E BioVentures among other backers.
The company has raised more than $100m in Series B+ financing to date.
