Norn Group Explains Why Drugs That Target Aging Are Tested as Treatments for a Single Disease
Norn Group Explains Why Drugs That Target Aging Are Tested as Treatments for a Single Disease
On July 24, Norn Group and Effie Klimi published an essay titled “Sisyphus, MD.” on clinical trial design. The authors argue that an intervention may be intended to treat several age-related diseases, but clinical trials usually test it against a single diagnosis.
According to the authors, a therapy intended to affect several aging processes enters clinical development through a specific disease, such as heart failure, Alzheimer’s disease, or diabetes. The company enrolls patients with that diagnosis, selects a measurable outcome in advance, and compares the treatment with usual care. A narrowly defined group provides a clearer signal of benefit and risk, which is easier to discuss with regulators, clinicians, and investors.
The testing process therefore narrows the drug’s purpose to a single diagnosis from the outset. After the first approval, the limited period of market exclusivity reduces the incentive to fund trials in other diseases. Each additional trial requires more money, patients, and time. As a result, a therapy intended to alter the overall course of aging becomes a treatment for one disease.
The authors propose evaluating treatment using two different outcomes. The first is the time until the first age-related disease occurs. The second is whether a person remains mobile, avoids frailty, and preserves “intrinsic capacity,” meaning the combined set of physical and mental abilities. This approach could allow a trial to measure functional decline and several age-related risks rather than a single diagnosis.
Such trials require reliable ways to measure these outcomes. The ARPA-H PROSPR program is developing biochemical and physiological markers, methods for collecting data at home, and protocols intended to make it possible to assess age-related outcomes within three years. In the Norn Group essay, this work serves as an example of the infrastructure needed to test broad hypotheses about aging in humans.