Drug trials targeting human longevity will likely have endpoints focused on the accumulation of age-related diseases rather than survival to demonstrate an extended life span and improvements in health and quality of life (QoL), experts said. Trials designed around survival, however, would be challenging due to their expected high cost and likely long durations, they added.
A proposed longevity trial of diabetes drug metformin, entitled Targeting Aging with Metformin (TAME), is thought to be a future model for longevity studies, experts said. The US National Institute of Health (NIH) funding applications are in progress for the TAME trial, which will start once funding is in place at an unforeseen date, said Mark Espeland, professor, Biostatistical Sciences Center of Diabetes, Obesity and Metabolism, Wake Forest School of Medicine, Winston-Salem, North Carolina, who is involved in TAME's design. Metformin was likely targeted due to it's first-line treatment status in type 2 diabetes and its longevity association in rodent models, according to public information.
Whilst TAME is targeted for 3,000 patients, future longevity studies, depending on the outcomes, could range as large as 20,000-30,000 individuals for statistical and clinical significance, one expert said. Functional outcomes and disability-free years and mobility are thought to be strong secondary outcomes, experts discussed.
A number of companies are involved in longevity drug development, such as San Francisco, California-based Unity Biotechnology, Baltimore, Maryland-based Insilico Medicine, Bainbridge Island, Washington-based BioViva, San Diego, California-based Human Longevity and Calico - a company established by Google (NASDAQ:GOOGL) and partnered with AbbVie (NYSE:ABBV). Big pharma previously expressed interest in the space with human longevity drug developer Sirtris Pharmaceuticals being acquired by GlaxoSmithKline (LON:GSK), before eventually being shut down in 2013 and staff transferring to GSK.