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Newsletter Summer 2018 - from Kinexum Founder - A tale of Two Different Scientific worlds

A number of Kinexers, including me, are about to make the annual pilgrimage to the American Diabetes Association meeting where we will be immersed in the cacophony of basic science and clinical data, technologies spanning nutrition, drugs, biologics, devices, and digital products, and commercialism.  It is quite remarkable to behold the impact of a hormonal deficiency state on so many people and the responses of our professional, industrial, and commercial infrastructures to this disorder.  Diabetes is big business, big science and medicine, and once a year in the US, a big meeting.  I will go on from Orlando to a very different scene, the annual meeting of the American Association on Aging (AGE) and American Federation of Aging Research in Philadelphia, where I will address the assembly on “Blazing clinical development and regulatory pathways for healthspan interventions.”  See https://www.americanagingassociation.org/Meeting

The AGE meeting consists mainly of basic scientists who utilize in vitro and animal models to discover and characterize candidate agents for extending lifespan. It is a much smaller scientific community with little corporate support. It’s a much smaller meeting than ADA’s.  The diabetes and healthy lifespan worlds could not be more different even though virtually every older adult has keen interest in the subject of anti-aging treatments, and many products with a healthy aging message are on the market.  Some high-powered companies, like Google’s Calico, have signed up for a moonshot-like commitment to finding lifespan interventions. But, compared to diabetes, the anti-aging world has very limited R&D going on. 

The most important reason for this tale of two different scientific worlds is simply economic—lack of incentives for investing in an enterprise that will lead to valuable products. Development and regulatory pathways for drug-like, healthy lifespan products remain to be established.   Until they are, our society will continue to pay for a lot of products with a good story but little data for to support safety and effectiveness.  It is not an easy challenge to solve because lifespan therapies will require more time and money to show safety and effectiveness than treatments for diabetes or other chronic illnesses.   

There are ways forward.  One good example is the TAME trial (Targeting Aging with Metformin), led by Nir Barzilai and supported by Kinexum.  TAME serves as a model for combining multiple, age-related conditions together, including cancer, cardiovascular disease and Alzheimer’s disease, in a single composite efficacy endpoint that, if positive, could support a healthy lifespan indication.  Metformin has been around a long time. No one is going to make a lot of money on metformin, even if it is approved for this indication.  But, since we have abundant evidence of metformin’s safety and epidemiologic evidence of efficacy against each of those conditions, it represents the low hanging fruit among all the potential interventions for healthy aging.  A related example with great promise is NuSirt and its combination of approved agents with dramatic pharmacologic synergy in lowering blood glucose, lipids, hepatic fat, body weight and blood pressure.  NuSirt, also supported by Kinexum, is targeting the standard disease indications related to the above effects, but I believe a NuSirt product would perform very well in a TAME-like trial. 

New molecule entities will generally have to be approved or at least have data for disease indications before they can be aimed at lifespan indications, but TAME does present a development pathway.  Is that also a regulatory pathway?  We shall see, but we at Kinexum want to help in blazing that pathway.  Kinexum has and will continue to support this field in other ways.  We bring a wide range of expertise in scientific benchmarking, clinical trial design, measurement technology (functional and patient reported), and working with FDA and other stakeholders to address the key challenges.  Kinexum will also continue to advance the concept of Metabesity—the constellation of major chronic disorders (cancer, dementia, obesity-diabetes, cardiovascular disease and the aging process itself—with common, metabolic roots.  The London Metabesity Congress was a terrific start to what we envision as an annual multidisciplinary gathering of experts and stakeholders who come together to work for preventions of Metabesity. 

With summer about to officially begin, I wish our friends and colleagues a season of health and re-creation.