Anecdotal results for dietary supplement show significant improvements in biological age and major reductions in key blood biomarkers.
The Florida-based firm is focused on the core principle of using a polytherapy approach to increase healthspan by leveraging synergies between existing compounds that impact on aging.
We caught up with PDL founder and CEO, Thomas Weldon, a well-known entrepreneur and venture capitalist, who has founded more than a dozen companies in the medical sector.
PDL Health primarily targets three key factors of aging: chronic inflammation, including cardiovascular and neurological disease; the mTOR pathway, which regulates the aging pathway, and; damage to DNA, such as cellular senescence and cancer.
PDL Health favours using generally recognised as safe (GRAS), non-pharmaceutical compounds over drug compounds to simplify regulatory approval and ensure patient safety.
The company’s inaugural product, Rejuvant, is a dietary supplement coupled with a non-invasive DNA methylation test to give consumers an indicator of the product’s effect on their biological age.
“We believe that aging is a software problem, not a hardware problem,” says Weldon. “The genome is the hardware. The epigenome is the software. Aging is caused by changes to the epigenome, due to damage and the passage of time. Rejuvant appears to rebalance your epigenetic DNA methylation pattern to that of a younger you, resetting gene expression, thus reversing epigenetic aging.”
PDL Health’s relationship with Professor Kennedy came through the company’s scientific partnership with his lab at the renowned Buck Institute for Research on Aging, which has developed a deep institutional knowledge on physiologic processes associated with aging. The Buck’s expertise in animal models led to a research agreement that saw the Buck conduct experiments on mice that showed Rejuvant had a profound and statistically significant effect on both lifespan and healthspan.
“Lifespan was increased by an average of 12% while also compressing morbidity by an average of 46%,” says Weldon. “This had the effect of increasing healthy years of life by an average of 41%. By reducing the time span of frailty and suffering, we can potentially save significant end stage healthcare costs.”
Rejuvant was also statistically significant postponing the onset of a range of age-related conditions, including frailty, grey hair, hair loss and more.
The results of the mouse data compelled the company to launch a commercial dietary supplement called Rejuvant LifeTabs, with different formulations for men and women. Using non-pharmaceutical compounds, the product did not require pre-market approval from the FDA and is commercially available today.
“This is undoubtedly the first example of repeatable results that may demonstrate that the human aging process can possibly be reversed simply by taking a pill.”
Early human data
Weldon and some of his family members have now been using Rejuvant for at least a year, and all have shown clear improvements in biological vs chronological age when measured using DNA methylation (DNAm) data. Results range from a difference of 13 years younger to an incredible 34 years in the oldest family member. The biological age measurement is performed by TruMe Labs, an independent DNAm testing lab.
“DNAm is the scientific gold standard for determining biologic age as opposed to chronologic age,” says Weldon.
Sharing his own blood biomarker data over seven months of using Rejuvant, Weldon shows his total cholesterol has reduced by more than 50%, while LDL (bad) cholesterol has dropped by an incredible 70%.
“This is undoubtedly the first example of repeatable results that may demonstrate that the human aging process can possibly be reversed simply by taking a pill,” he says.
The results in mice and humans have led PDL Health to begin a placebo-controlled, randomised human clinical trial, at the Indiana University Medical Center in Indianapolis.
The study is intended to support specific marketing claims for the Rejuvant products and will include 80 volunteers, with measurements at inception, three months, six months and nine months.
“Yes, there is academic oversight, it is an independent trial,” says Weldon. “The primary endpoints are safety and a reduction in CRP. Secondary endpoints are a reduction in biologic age, as measured by DNAm testing and changes in typical blood phenotypes.”
The company has raised about $10 million to date, and Weldon is now in the process of actively raising around $10M more for a Series B round of funding.
“This will get us through the clinical trial, and well into next year,” he says.