Life Biosciences (Life Bio) has received US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application, allowing it to begin a clinical trial of ER-100 for optic neuropathies.
The Phase I first-in-human trial will evaluate both the safety and the therapeutic potential of ER-100 to improve vision in people affected by these conditions.
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It will recruit patients with non-arteritic anterior ischaemic optic neuropathy (NAION) and open-angle glaucoma (OAG).
The objective of this trial is to assess the immune responses, tolerability, safety and impact of ER-100 on various visual assessments in these patient groups.
Participants will be given a single ER-100 dose and undergo safety evaluations, which include a comprehensive eye examination and laboratory tests.
They will also provide samples of bodily fluids such as tears, saliva, faeces and urine to assist researchers in understanding the drug’s processing and elimination from the body.
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By GlobalDataThe study participants will also complete questionnaires regarding their quality of life and will be monitored for a duration of up to five years to assess long-term health and vision outcomes.
ER-100 is derived from Life Bio’s Partial Epigenetic Reprogramming (PER) platform that seeks to restore cells affected by age or injury to a youthful state by altering cell epigenomes and biochemical markers.
Life Biosciences chief scientific officer Sharon Rosenzweig-Lipson said: “This important milestone in reaching the clinic is the result of years of research, optimisation, and comprehensive non-human primate studies demonstrating controlled OSK expression, restoration of methylation patterns, and improved visual function, all of which have culminated in this IND clearance.
“These results have paved the way for first-in-human evaluation of our cellular rejuvenation approach with the goal of improving the lives of people facing debilitating age-related disease, starting with optic neuropathies.”
Optic neuropathies result from the irreversible death of retinal ganglion cells (RGCs), which connect the eye to the brain.
