A startup cofounded by a renowned Harvard geneticist has taken a step toward cracking the human body’s biological breakdown by securing FDA approval to test its cutting-edge gene therapy on humans.
Life Biosciences, a biotech company cofounded by Harvard genetics professor David Sinclair, said Wednesday it had secured approval for a Phase 1 clinical trial aiming, in part, to restore vision in people with eye conditions such as glaucoma and non-arteritic anterior ischemic optic neuropathy (NAION) through “partial epigenetic reprogramming.” During the trial, researchers will attempt to turn back the biological clock on damaged cells in a person’s eye by directly injecting it. This allows the therapy to reach damaged retinal ganglion cells and deliver “rejuvenation instructions” directly to the target cells to help restore their function and potentially reverse vision loss.
The company will enroll its first patients over the next couple of months, with results potentially coming by the end of the year or early next year, CEO Jerry McLaughlin told Fortune.
McLaughlin, a pharmaceutical industry veteran who previously worked at Merck and at venture-backed biotechs such as Neos Therapeutics and AgeneBio said the approval was groundbreaking: “It’s a transformational day, I think, for science overall, for Life Biosciences, for the field of partial epigenetic reprogramming,” he said.
