Monday, July 03, 2023

What is a longevity biotechnology company?


Nature Biotechnology
has this interesting Correspondence on defining a longevity biotechnology company.  An excerpt:

Basic research on the biology of aging has resulted in the discovery of more than 75 interventions that extend lifespan in rodents and many more that extend lifespan in Drosophila and Caenorhabditis elegans. The progression of this work to human trials was historically delayed by the misconception that interventions originally identified to extend rodent lifespan lacked a feasible translation strategy or were unattractive investment opportunities for investors and pharmaceutical companies. In the last 5 years, however, efforts to move those interventions into human experimentation have come to fruition. The biotechnology companies developing such treatments have created a new field of biopharmaceutical development: longevity biotechnology. Because longevity biotechnology represents a paradigm shift in therapeutic approach and faces unique challenges from the standpoint of clinical development, path to approval and patient population, it makes sense to define this rapidly advancing field and articulate standards that identify its bona fide constituents.

....The efficacy of a new intervention can only be rigorously demonstrated by a sufficiently powered clinical trial. Today, there are products on the market that claim to boost longevity but lack robust scientific evidence in humans to support these claims. Academic scientists, drug developers and entrepreneurs developing new drugs arising from aging research need to direct their efforts toward elucidating the mechanisms of action of potential interventions and conducting human trials. Similarly, investors, regulators, members of the media and others require a framework to evaluate the claims made by translational longevity biotechnology projects and their potential to demonstrate effectiveness of an intervention in humans.

....To fully realize the benefits of preventive medicines, the regulatory pathway will need to allow the testing of gerotherapeutics in younger individuals in relatively good health. Incorporating biomarkers of aging as surrogate endpoints in clinical trials, potentially including the use of algorithms trained on multi-omics data, will be crucial to advancing the field12. Until surrogate endpoints are validated by clinical data, composite outcome-based endpoints, as seen in the TAME trial blueprint — such as reducing the incidence or prevalence of multiple age-associated diseases — will remain best practice.

Cheers, 

Colin