US-based biotechnology company Ocugen has dosed the first subject in a multicentre Phase I trial of OCU200 for diabetic macular oedema (DMO) treatment.
The open-label, dose-escalation trial will explore dosage levels of 0.025mg, 0.05mg and 0.1mg across three cohorts.
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It will assess the safety of the therapy, which will be administered through intravitreal injection.
Participants in the trial will be administered two intravitreal injections of the drug six weeks apart, with subject follow-up taking place up to three months after the final injection.
OCU200 is a recombinant fusion protein that comprises tumstatin and transferrin, joined by a linker.
Tumstatin serves as an anti-inflammatory and anti-vascular endothelial growth factor (VEGF) agent by targeting integrin receptors while transferrin aims the drug towards the choroid and retina via transferrin receptors binding on endothelial cells.
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By GlobalDataThese mechanisms are anticipated to decrease inflammation, neovascularisation and vascular permeability, which are key factors in the pathophysiology of DMO, diabetic retinopathy (DR) and wet age-related macular degeneration (AMD).
Ocugen chairman, co-founder and CEO Dr Shankar Musunuri said: “OCU200 has the potential to change the treatment landscape for DMO, DR and wet AMD with its unique mechanism of action, binding the active component—tumstatin—to integrin receptors that play a crucial role in disease pathogenesis.
“OCU200 holds the promise to benefit all DME patients, including the 30-40% of patients who do not respond to current anti-VEGF therapies.”
Ocugen aims to secure approval for the therapy to be used as a first-line treatment for these conditions, which collectively affect nearly 12 million individuals in the US and 130 million worldwide.
Last April, the company finished dosing in the second cohort of its Phase I/II ArMaDa trial for OCU410, its modifier gene therapy candidate.
OCU410 is a modifier gene therapy candidate designed for treating geographic atrophy, an advanced stage of dry AMD.
