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news.Lpath has announced that the FDA, after review of the company's April 2008 investigational new drug submittal, has allowed Lpath to administer iSONEP to patients suffering from exudative age-related macular degeneration in a Phase I clinical trial.
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The Phase I protocol calls for a multi-center, open-label, single-arm, dose-escalation trial in the US. Investigators will assess the safety and tolerability of an intravitreal injection of iSONEP in subjects with choroidal neovascularization secondary to age-related macular degeneration (AMD). Other endpoints include pharmacokinetics, immunogenicity, and visual acuity. Subjects will receive a single dose of iSONEP in one eye, with doses escalating from 0.2mg to 1.8mg.
According to the company, iSONEP is the first ocular drug candidate ever to target a bioactive lipid. iSONEP, generated via Lpath’s proprietary ImmuneY2 drug discovery engine, is a humanized monoclonal antibody that neutralizes sphingosine 1-phosphate, a bioactive lipid that contributes to the inflammation, scarring, and angiogenesis that are characteristic of exudative AMD patients.
Although Lpath will conduct this Phase I trial in wet AMD patients, the company considers iSONEP, with its multiple mechanisms of action, to be a potential treatment for a broad range of ocular diseases, including dry AMD, diabetic retinopathy, glaucoma-related surgeries, proliferative retinopathy, and other therapeutic areas with significant unmet medical needs.