Life Biosciences Announces FDA Clearance of IND Application for ER-100 in Optic Neuropathies
IND clearance marks the first ever cellular rejuvenation therapy using partial epigenetic reprogramming to reach human clinical trials
BOSTON, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Life Biosciences, Inc., (“Life Bio”) a biotechnology company pioneering cellular rejuvenation therapies to reverse and prevent multiple diseases of aging, today announced that the U.S. 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 program evaluating ER-100’s safety and potential to improve vision in patients with optic neuropathies. The Phase 1 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 preclinical 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, optimization, and comprehensive nonhuman primate studies demonstrating controlled OSK expression, restoration of methylation patterns, and improved visual function, all of which has culminated in this IND clearance,” said Sharon Rosenzweig-Lipson, Ph.D., Chief Scientific Officer, Life Biosciences. “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.”
About Optic Neuropathies
Optic neuropathies are a group of disorders characterized by the irreversible death of retinal ganglion cells (RGCs), the primary neurons connecting the eye to the brain. Because RGCs cannot naturally regenerate, their loss results in permanent vision impairment. Open-angle glaucoma (OAG) is a chronic neurodegenerative disease and a leading cause of blindness. While often associated with elevated intraocular pressure, RGC damage frequently continues despite treatment, and some patients suffer from OAG despite normal intraocular pressure. Non-arteritic anterior ischemic optic neuropathy (NAION), often termed “stroke of the eye," is the most common acute optic neuropathy in adults over fifty. It involves sudden, painless vision loss due to insufficient blood flow, for which there are currently no approved treatments. Prevalence and incidence of both of these diseases rise with age, creating a growing global burden. Yet current standards of care fail to address the underlying neuronal degeneration, leaving a significant unmet medical need for disease-modifying therapies that can directly protect or regenerate RGCs to restore or preserve sight.
About Life Biosciences
Life Bio is a clinical-stage biotechnology company pioneering cellular rejuvenation therapies to reverse and prevent multiple diseases of aging. The company’s proprietary Partial Epigenetic Reprogramming (PER) platform utilizes three transcription factors—OCT4, SOX2, and KLF4—to restore older and damaged cells to a younger and healthier state. This innovative approach targets a root cause of aging at the epigenetic level, thereby offering the potential to address a wide range of serious age-related diseases. Life Bio’s lead program, ER-100, in development for optic neuropathies, including open-angle glaucoma (OAG) and non-arteritic anterior ischemic optic neuropathy (NAION), with a Phase 1 clinical trial initiated in the first quarter of 2026 for both indications. Beyond ER-100, the company is strategically broadening its therapeutic pipeline to address additional age-related diseases, underscoring the platform’s versatility and transformative potential. For more information, visit www.lifebiosciences.com or follow Life Bio on Twitter (X) and LinkedIn.
Media Contact
Jason Braco, PhD
LifeSci Communications
lifebio@lifescicomms.com
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