Boston, Massachusetts-based biotech startup Life Biosciences announced that the first patient in a clinical trial received a cell-reprogramming injection designed to reverse age-related diseases. The injection was given with the experimental drug ER‑100 into the eyeball with glaucoma, which appears in people over 40 years of age.
During the first phase of trials, the safety and tolerability of ER-100 will be assessed, as well as additional endpoints related to the assessment of visual function, as specified in a press release from the developer company. The substance is designed to restore cellular function by returning the epigenetic code to younger patterns of gene expression.
Research has shown that aging is largely due to the loss of this epigenetic information, rather than irreversible damage, said David Sinclair, co-founder of Life Biosciences and professor of genetics at Harvard Medical School. The current stage of testing, according to the doctor, is an important moment for the entire field of biology of aging.
“This clinical trial is the first opportunity to test whether restoring this information can improve the condition of patients with various diseases,” Sinclair said.
The drug is the result of years of rigorous scientific development and applied research, said Sharon Rosenzweig-Lipson, chief scientific officer at Life Biosciences. Preclinical experiments have shown that the method can restore epigenetic patterns associated with healthy cellular function, improve tissue function and restore visual function in animals, the doctor says.
“The introduction of ER-100 into clinical practice is an important step toward establishing epigenetic therapies as a new class of drugs for age-related diseases,” said Rosenzweig-Lipson.
Vision loss from glaucoma and other eye diseases not only directly impacts patients' quality of life, but also increases the risk of loss of independence, severe falls, and depression and dementia due to social isolation, highlighting the need for therapy, Life Biosciences notes.
This is a turning point in the science of longevity and an opportunity to prove that the drug can actually slow down aging in real-world conditions, writes Business Insider.
The publication notes that Life Biosciences is not the only company working in this area. Billionaires including Jeff Bezos and Sam Altman, as well as pharmaceutical giants Merck and Eli Lilly, are increasingly investing in the idea.
Today's anti-aging efforts build on the work of scientist and surgeon Shinya Yamanaka, who was the first to successfully reprogram adult human cells in 2007, for which he received a Nobel Prize.
“Yamanaka factors,” as they are now called, are four specific proteins that can reprogram cells, restoring the ability of old cells to function in new ways, the business publication notes. The potential for cellular reprogramming is enormous, but there are also many problems, the main one being the high risk of cancer. During cell reprogramming studies in mice, some mice developed tumors.
“Critics are concerned that two of the four cellular reprogramming factors identified by Yamanaka are oncogenes that can divide indefinitely,” Business Insider points out.
For this reason, Life Biosciences uses only three of the four “Yamanaka Factors” and controls the therapy with doxycycline, a broad-spectrum antibiotic. Scientists who study longevity recognize that these treatments can have a significant impact on the aging process, much more than dietary supplements or repurposed generic drugs, that is, drugs that treat diseases or conditions for which they were not originally intended.
At the same time, the scientific community is cautious, and some of its representatives are skeptical about the method. Brian Kennedy, director of the Center for Healthy Longevity at the National University Health System in Singapore, noted that there is insufficient knowledge to safely and effectively carry out such procedures on people.
