Eluminex Biosciences (Eluminex), a China-based clinical stage, privately held biotechnology company involved the development of advanced protein therapeutics for vision-threatening diseases, announced on Monday that it has started dosing in the phase 1b Lotus trial of the novel trispecific fusion antibody EB 105 in subjects with Diabetic Macular Edema (DME).
The LOTUS trial, a first-in-human, open-label, multicentre, single injection, dose-escalation study of EB-105, the company's lead ophthalmology asset, is being carried out at four sites in the United States. It is intended to assess three dose levels of EB105 in subjects with centre-involved diabetic macular edema and will enrol approximately 12 patients (four per dose level). The primary objectives of the study 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 expected in 2025. Topline data from the current single injection study is expected in the first half of 2025. Vial, Inc, a clinical research organisation (CRO) based in San Francisco, is facilitating the study. EB-105 has been shown in preclinical studies to potently inhibit VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R signalling.
Charles Semba, MD, Eluminex's chief medical officer, 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.'
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