Life Biosciences Secures FDA Approval For ER-100, The First Cellular Rejuvenation Therapy Using Epigenetic Reprogramming To Enter Human Trials For Vision Loss

Life Biosciences, Inc., a biotechnology company focused on developing cellular rejuvenation therapies to prevent and reverse a range of age-related diseases, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for ER-100. This clearance marks an important step forward in advancing Life Bio’s work in aging science and enables the Company to begin clinical testing of its lead program.

With the IND approved, Life Bio can now launch its first clinical study to evaluate the safety of ER-100 and explore its potential to improve vision in patients living with optic neuropathies. The Phase 1 trial (NCT07290244) will enroll individuals diagnosed with open-angle glaucoma and non-arteritic anterior ischemic optic neuropathy. The study will focus on understanding the therapy’s safety profile, tolerability, immune responses, and its effects across a range of visual assessments.

ER-100 was developed from Life Bio’s Partial Epigenetic Reprogramming platform. This platform is designed to help aged or damaged cells regain more youthful characteristics by adjusting the cell’s epigenome—biochemical markers that influence how genes are expressed without altering the DNA itself. The approach uses a controlled method to express three of the four Yamanaka factors—OCT-4, SOX-2, and KLF-4, collectively known as OSK. In multiple preclinical models, especially where the therapy was injected into the eye, ER-100 has shown promising safety and early signs of restoring function. It is also the first epigenetic reprogramming-based cellular rejuvenation therapy ever cleared by the FDA to enter human clinical trials.

Sharon Rosenzweig-Lipson, Ph.D., Chief Scientific Officer at Life Biosciences, said that reaching this point is the result of extensive research and development. She explained that years of optimization and studies in nonhuman primates have shown controlled OSK expression, restoration of key methylation patterns, and improvements in visual function. She added that these findings supported the IND application and helped open the door to evaluating ER-100 in humans for the first time. According to her, the Company’s goal is to bring forward therapies that meaningfully improve the lives of people affected by serious age-related diseases, beginning with conditions that cause vision loss.