The National Institutes of Aging in the United States, a component of the National Institutes of Health, is funding clinical trials for interventions that directly affect the root causes of age-related diseases.
Direct funding for trials against aging
Probably the most important and interesting part of this Funding Opportunity Announcement (FOA) is that the NIA specifically mentions “multiple chronic conditions” caused by the processes of aging along with more conventional trials that are targeted directly at specific downstream effects of aging.
This wording represents an enormous change, and a potential enormous opportunity, for aging researchers seeking to test their products in human clinical trials, as it addresses one of the largest concerns: endpoints. Companies that are creating rejuvenation biotechnology interventions must develop their products to target individual diseases in order to be approved by the FDA. While that is still the case, this particular FOA is intended to promote broader research that does not necessarily target individual diseases as endpoints.
What is, and isn’t, this funding for?
This FOA does not apply to stem cells (which are already heavily researched), nor does it allow the funding of “definitive efficacy or safety trials”. It is intended for early-stage, investigative human clinical trials into the feasibility of interventions against the root causes of aging, including supplements, biologics, new drugs, and existing drugs.
The NIA intends to fund Stage 1 trials that assess safety and tolerability while analyzing the pharmacological effects of interventions, Stage 2a proof-of-concept pilot studies that determine on- and off-target effectiveness along with interactions with other drugs, and Stage 2b studies that will serve as the basis of future trials that determine efficacy more definitively.
This funding is open to a wide variety of groups based in the United States, including private corporations, state government entities, and public institutions such as universities.
Applicants are expected to propose trials of new and repurposed molecular entities in healthy volunteers or target patient populations that are designed to do the following:
- Assess safety and tolerability, characterize the dose-limiting adverse reactions, or determine the maximum tolerated dose
- Evaluate pharmacokinetics, pharmacodynamics, or interactions with co-existing conditions and medications
- Evaluate select characteristics of safety and efficacy such as dose-response and routes of administration
- Assess degree and specificity of molecular and cellular target engagement, and/or off-target effects
- Generate evidence of early clinical efficacy and safety of interventions on intermediate clinical outcomes and/or predictors of clinical outcomes
Conclusion
While we won’t see any results from any trials funded by this FOA for quite some time, as the earliest such a trial can begin is in April 2022, this is incredibly good news for the longevity community. Many people have been hoping that the federal government of the United States would directly fund research into human clinical trials of longevity itself, and that day appears to have come. While this FOA certainly does not equate to a full-throated endorsement of rejuvenation biotechnology nor life extension as a whole, it represents the fact that the NIA is now officially willing to put federal dollars towards truly solving a problem that causes tremendous harm and already soaks up an enormous percentage of the federal budget: aging.
