Life Biosciences, a biotech company founded by Harvard genetics professor David Sinclair, SAYS On Wednesday it won approval for a Phase 1 clinical trial that aims, 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, the researchers try to turn back the biological clock in the damaged cells of a person’s eye by directly injecting them. This allows the therapy to reach the 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 in the next few months, with results likely by the end of the year or early next year, CEO Jerry McLaughlin said. luck.

McLaughlin, a former pharmaceutical industry veteran Merck and venture-backed biotechs such as Neos Therapeutics and AgeneBio said the approval was groundbreaking: “This is a transformational day, in my opinion, for general science, for Life Biosciences, for the field of partial epigenetic reprogramming,” he said.

The FDA approval, which McLaughlin says researchers in his industry have been waiting for for years, puts the lean Life Biosciences team (fewer than 20 people) ahead of the pack, as the longevity boom is largely underwritten by billionaire cash.

Altos Labs, one of the highest profile bet on cell rejuvenationlaunched with $3 billion in funding in 2022 and reportedly counting Amazon founder and fourth richest man in the world Jeff Bezos as a early supporter. Meanwhile, NewLimit, the longevity startup founded by the billionaire Coinbase CEO Brian Armstrong last year raised $130 million in Series B financingto continue epigenetic reprogramming. Even Elon Musk, Tesla The CEO and the richest man in the world, recently entered the longevity chat, saying in Davos aging is a “very solvable problem.”

Deal with vision loss first

Instead of focusing on whole-body de-aging, Life Biosciences’ takes a “staged approach” to de-aging, first dealing with optic neuropathies, conditions where damage to the optic nerve can destroy vision. The trial aims to restore some vision to both patients with glaucoma and NAION—both of which can cause blindness. Glaucoma is the second leading cause of blindness worldwide, according to the Centers for Disease Control and Prevention, and it especially because it is widespread in adults between the ages of 64 and 84. NAION, on the other hand, is “the most common acute, optic neuropathy” in people over 50. McLaughlin said the company chose to focus on these diseases because of their huge impact on patients.

“The bad news is that there is no perfect treatment (NAION), and the worse news is that there is about a 20-to-30% chance in the next two to three years that it will occur in the second eye,” he said.

McLaughlin said Life Biosciences is already applying its epigenetic reprogramming to help treat other conditions. The company has previously seen success in the treatment of liver fibrosis, or MASHwhich he says reflects the company’s approach to “transcending organs.”

While the company is primarily focused on helping patients with vision loss, McLaughlin is not ignorant of the potentially huge opportunity that will open up thanks to a rapidly aging world population.

“Our population replacement is not where it is in the U.S. We’re way below population replacement,” McLaughlin said. “It’s worse in other parts of the world, and with a rapidly aging population, extending healthy human life is important, from an economic point of view, and for society as a whole.”

The world’s cumulative fertility rate has been declining for years, but the US fertility rate, in particular, has hit a record low. in 2024at 1.6 children per woman, below the replacement level of 2.1 children per woman. The country’s fertility rate is on par with other advanced economies, such as Iceland and the United Kingdom, according to data from the World Bank. Some came even lower, such as Japan, which recorded a fertility rate of 1.15 children per woman in 2024, according to a local government agency.

The science behind Life Biosciences

Life Biosciences cofounder and Harvard geneticist Sinclair was key behind the company’s FDA collapse. Previously Sinclair, who earned a Ph.D. in molecular genetics from the University of New South Wales, led pioneering research on partial epigenetic reprogramming, partially de-aging cells by changing their epigenome, biochemical markers that tell genes when to turn on or off without changing the underlying DNA sequence.

Sinclair’s research shows that, by using three of the four proteins that the Nobel prize-winning Japanese scientist Shinya Yamanaka which was previously found to completely reset the age of a stem cell in pluripotency-or a blank state-researchers can regenerate cells without completely resetting them so that they “forget” their original function. The partial reset of cells has more potential for therapeutic uses because these cells “maintain” their identity, because they are partially aged, unlike the complete reset of cells that “forget” their function and become tumors.

Sinclair laid the groundwork for his work using mice in preclinical tests, Life Biosciences then licensed technology from Harvard and Sinclair’s lab to test nonhuman primates to better match the anatomy of the human eye.

In those studies, McLaughlin said, Life Biosciences induced NAION-like damage and then used treatment to reverse vision loss and restore it to healthy monkeys.

Despite the growing competition in the space, McLaughlin is not afraid of competitors, and he said that the large amount of money and activity in the long-lived space is necessary. After the FDA approval, more companies will be able to follow the steps of Life Biosciences and focus more on epigenetic reprogramming, he said, which in general will be positive for the field.

“We believe this has some of the highest prospects, best prospects, in aging science—partial epigenetic reprogramming,” he said. “As we continue to build evidence, the evidence will only bring more people to the field.”