Metformin, a widely used drug for treating diabetes, has shown promise in epidemiological studies for preventing age-related conditions such as heart attacks, cancer, and Alzheimer’s disease. Despite this potential, a pivotal trial investigating its effects on aging, the TAME (Targeting Aging with Metformin) trial, faces significant funding challenges.
The TAME Trial: Aims and Objectives
Nir Barzilai, head of the Institute for Aging Research at the Albert Einstein College of Medicine, has been spearheading efforts to conduct a clinical trial that targets aging. The TAME trial aims to track 3,000 elderly individuals over five years to determine if metformin can delay the onset of cardiovascular disease, cancer, cognitive decline, and mortality. The trial's design is based on the premise that metformin can address multiple comorbidities associated with aging, potentially paving the way for the FDA to recognize aging as a treatable indication.
Regulatory Hurdles and Innovative Trial Design
The FDA's traditional "one disease, one drug" model poses a significant obstacle to developing drugs that target aging. Since aging is not recognized as a disease, there is no clear regulatory pathway for approval. To overcome this, Barzilai's approach involves using biomarkers as proxies, similar to how statins were approved based on changes in cholesterol levels rather than direct prevention of heart attacks. The TAME trial seeks to demonstrate that metformin can delay the onset of multiple age-related diseases simultaneously.
Funding Challenges and Philanthropic Interests
Despite receiving FDA agreement in 2015, the TAME trial has struggled to secure the necessary funding, estimated between $30 million and $50 million. While the National Institutes of Health provided a portion of the funds for biomarker screening, the remaining amount has been difficult to raise from philanthropists. Barzilai notes that many wealthy donors prefer funding high-impact, innovative projects rather than supporting trials involving generic drugs like metformin. James Peyer, CEO of Cambrian Biopharma, emphasizes the potential of the TAME trial to create a framework for biotechnology companies, but laments the lack of progress due to funding constraints.
Seeking Alternative Funding Sources
Barzilai has been exploring alternative funding sources, including engaging with crypto-millionaires and Hevolution, a nonprofit research organization founded by the Saudi Arabian royal family. While Hevolution has expressed interest in funding projects related to aging, no firm commitments have been made to the TAME trial. The ongoing funding challenges highlight the difficulties in supporting research that targets aging as a whole, despite its potential to address multiple age-related diseases.
