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.
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.
The FDA approval, which McLaughlin said researchers in his industry have been waiting on for years, puts the lean Life Biosciences team (fewer than 20 people) ahead of the pack, as the longevity boom is increasingly being underwritten by billionaire money.
“The bad news is there’s absolutely nothing to treat [NAION], and the even worse news is that there’s about a 20-to-30% chance in the next two to three years it’s going to happen in the second eye,” he said.
While the company is first focused on helping patients with vision loss, McLaughlin isn’t ignorant about the potentially giant opportunity opening up thanks to a rapidly aging global population.
“Our population replacement is not there in the U.S. We’re well below population replacement,” said McLaughlin. “It’s worse in other parts of the world, and with a rapidly aging population, extending healthy human lifespan is critical, from an economic standpoint, and for society overall.”
Life Biosciences cofounder and Harvard geneticist Sinclair is the key behind the company’s FDA breakthrough. 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 modifying their epigenome, biochemical markers that tell genes when to turn on or off without altering the underlying DNA sequence.
Sinclair laid the foundation for his work using mice in preclinical trials, Life Biosciences then licensed the technology from Harvard and Sinclair’s lab to test on non-human primates to better match the human eye’s anatomy.
In those studies, McLaughlin said, Life Biosciences induced a NAION-like injury and then used the treatment to reverse the vision loss and restore it to that of a healthy primate.
Despite the increasing competition in the space, McLaughlin isn’t scared of competitors, and he said the large amount of money and activity in the longevity space is warranted. Following the FDA approval, more companies may even follow Life Biosciences’ footsteps and focus more on epigenetic reprogramming, he said, which could overall 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 generate evidence, evidence is only going to bring more people to the field.”
