Life Biosciences announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ER-100.

The IND clearance allows Life Bio to initiate a clinical programme evaluating ER-100’s safety and potential to improve vision in patients with optic neuropathies. The phase-I first-in-human study (NCT07290244) will enroll individuals with Open-Angle Glaucoma (OAG) and Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) to assess safety, tolerability, immune responses and impact on multiple visual assessments.

ER-100 originated from Life Bio’s Partial Epigenetic Reprogramming (PER) platform, which aims to restore aged or injured cells to a younger state by modifying the epigenome of cells, biochemical markers that regulate gene expression without altering the underlying DNA sequence. Life Bio’s approach allows for the controlled expression of three of the four Yamanaka factors, the transcription factors OCT-4, SOX-2 and KLF-4 (OSK), and has demonstrated safety and efficacy in multiple pre-clinical animal models by local injection into the eye (intravitreally). ER-100 is the first-ever cellular rejuvenation therapy using epigenetic reprogramming to receive FDA clearance to enter human clinical trials.

“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 has 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,” said Sharon Rosenzweig-Lipson, PhD, Chief Scientific Officer, Life Biosciences.