New funding opportunity for longevity clinical trials from National Institute on Aging emphasises preventing aging and age-related disease.
Longevity.Technology: Previously, the FDA has approved biotech interventions that address individual diseases, rather than tackling aging itself. However, this funding opportunity is available to researchers who want to treat multiple chronic conditions by modulating fundamental aging-related mechanisms. In short, those who want to target aging itself. This paradigm shift in approach is fantastic news for longevity research, as the US Government puts its federal dollars where its mouth is.
Applications are invited for Phase 1, 2a and 2b clinical trials of new compounds or re-purposed existing drugs, biologics (except stem cells), or supplements to treat multiple chronic conditions by modulating fundamental aging-related mechanisms. The funding is also available to test compounds that could affect individual diseases and conditions that disproportionally affect older adults, although this funding opportunity application is not intended to provide support for definitive efficacy and safety trials.
This funding is open to a range of organisations based in the US, including universities, government research facilities, hospital research departments and private corporations. Applications must be submitted by 17th June of this year, with an earliest start date of April 2022 indicated.
The NIA intends to commit $4,500,000 in total costs in FY 2022 to fund 4-6 awards which is low considering the costs associated with later-stage clinical trials: but it’s a welcome start.
The NIA is clear about the change in focus that that this funding brings. “There is significant interest in the identification and testing in clinical trials of compounds that could treat individual or multiple age-related conditions by modulating fundamental aging-related mechanisms,” states the invitation. “A variety of compounds that modulate these processes have been extensively tested in model organisms, but just a few have crossed the translational divide between late-phase preclinical studies and early-phase clinical trials.”
The NIA defines longevity clinical trial stages as:
Phase 1 – focusing on assessing safety and tolerability, characterising the dose-limiting adverse reactions, determining the maximum tolerated dose and studying the pharmacokinetics (PK) and pharmacodynamics of new and repurposed molecular entities in healthy volunteers or in target patient populations.
Phase 2a – proof-of concept pilot studies to determine effects on clinical outcomes or predictors of clinical outcomes, the degree and specificity of molecular and cellular target engagement, off-target effects, and interactions with co-existing conditions and medications. Safety and efficacy testing may be done in a small number of patients. In addition, the optimal frequency of dose can be also explored in these types of trials.
Phase 2b – using rigorous scientific designs to inform decisions about the need for and feasibility of future definitive efficacy trials.
The NIA states that 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, characterise 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
$4.5m is a good start towards getting clinical trials in humans that target aging and prevent and treat multiple diseases underway. Clinical trials aren’t cheap and can often trigger more questions than they answer, so Longevity.Technology hopes that this funding opportunity is the first of many and that it represents a paradigm shift in the treatment of aging. Let’s tackle aging, and age-related diseases, early, aggressively and intelligently and ensure that longevity, both in terms of extended lifespan and improved healthspan, is a reasonable aspiration for everyone.