Life Biosciences started enrolling Phase 1 patients this quarter for ER-100. Three Yamanaka factors (OCT4, SOX2, KLF4) delivered as gene therapy into damaged optic nerves of glaucoma and NAION patients. First partial epigenetic reprogramming therapy ever cleared by the FDA. Trial NCT07290244, IND granted January 15, primary readout expected inside twelve months.

The thesis that an old retinal ganglion cell could be instructed to act younger by rewriting its epigenome was a heresy in 2012, a Sinclair lab paper in 2020, a regulatory submission in late 2025. The aging field spent two decades arguing senescence was too entangled with metabolism, immunity, telomere dynamics, and tissue-specific decline to address through a defined intervention. The IND that cleared in January carries three transcription factors aimed at a target organ on a clinical timeline.

What enters first-in-human this quarter is gene therapy with a binary endpoint, an ophthalmologic readout, and a regulatory frame the FDA has been running for forty years. Either the trial restores vision in eyes the prior standard of care abandoned or it does not. Liver, hematopoietic, and neuronal indications wait on the same cellular machinery.

The hypothesis is on the trial schedule now.