In this multipart special report, BioWorld explores the concept of extending lifespan, which is surprisingly well-validated by basic research. The team examined the latest science, the key biological drivers that can be targeted pharmacologically and the companies developing these potential “Fountain of Youth” candidate drugs. For the researchers and companies involved, the emphasis is on living longer in a healthy way. And that’s important since the global population of people 65 and older rose 468% between 1950 and 2020. In what could be a holy grail for humanity, anti-aging drugs would simultaneously reduce the risk of multiple age-related illnesses in one. BioWorld found that investments in life-extending drugs and the number of clinical trials are on the rise. The special report explores why it’s a waste of time to try to first cure Alzheimer’s, cataracts, strokes, and other diseases of aging. Instead, many forward-thinking scientists are focusing on the biology of aging. Can we hopscotch over those diseases? The impact could be staggering. Equitable access to drugs and therapies tackling aging could reduce health care costs in a major way and improve quality of life. 

Investments in lifespan-extending drugs, number of clinical trials are growing  

There is no drug that will halt the inevitable process of getting older each year. But biopharmaceutical research can have a positive impact on preventing diseases that come with aging, thereby extending life for the masses, and more importantly, extending quality of life. The number of clinical trials of therapeutics designed to interrupt the process that leads to cancer and cardiovascular disease, among other life-threatening conditions, appears to be increasing, as is the amount of money that investors are putting into this space.

Live long and prosper? Science says you can  

To most people, trying to prevent aging seems like a dream – maybe a pipe dream, in fact. But a dream for sure. To aging researchers, it seems like common sense. And if animal studies are any indication, maybe not that hard, either.

Preventing worse inequities

Altos Labs Inc. reportedly attracted Amazon founder Jeff Bezos as an investor when it launched in early 2022, with an eye-popping $3 billion in funding. That inevitably led to suggestions that biopharmas are looking to make billionaires immortal. According to companies that specialize in funding research into aging, the idea is to encourage health care systems and payers to evolve and focus more on preventing ill health. Nevertheless, there are important ways in which anti-aging research has the potential to make existing inequities worse.

For preventing aging, some decades old drugs?

In one sense, aging is indeed inevitable. But the best available data suggest that many of the diseases that come with aging could be avoided – that it is possible, in the words of American Federation for Aging Research (AFAR) scientific director Nir Barzilai, “to die young at a very old age.” The U.S. NIH’s National Institute on Aging’s Intervention Testing Program (ITP) has been searching for ways to extend lifespan for more than two decades by now. And in its animal studies, it has been successful multiple times.

How the ITP works  

Remarkably, the U.S. NIH’s National Institute on Aging’s Intervention Testing Program (ITP) has achieved its success rate while keeping to the highest standards of scientific rigor.

Beyond rapalogs and metformin, moonshots at the Fountain of Youth 

A lot of what goes on during aging remains too poorly understood for straightforward translation. There are hallmarks of aging, and researchers are getting a handle on its biological mechanisms. Nutrient sensing has repeatedly been implicated, as have inflammation and oxidative stress. Senescence is the newest belle of the aging ball. But in a basic sense, “we still don’t have much of an idea what causes aging,” Björn van Eyss told BioWorld. Aging affects everything, but identifying key biological drivers that could be targeted pharmacologically in that sea of changes is challenging work.

When big dreams meet big money, can science stay first-rate? 

In the biopharma industry, the sirtuins have been a cautionary tale of some of the challenges in translating aging research.

Aging is not an endpoint: New regulatory, reimbursement approaches needed 

If anti-aging drugs are to become widely available and adopted, especially in the U.S., they have some serious hurdles to overcome. And those hurdles aren’t all in the lab or clinic. With classes of anti-aging drugs already in the pipeline, “the biggest hurdle is FDA approval. Then reimbursement,” George Kuchel, a professor and director of the UConn Center on Aging at the University of Connecticut, told BioWorld. To succeed, developers of these drugs will need to find a regulatory sweet spot, he added.

Nestle banks on Enterome’s gut bacteria approach for IBD, food allergies

Microbiome specialist Enterome SA has out-licensed its lead human hormone mimetic, EM-1010, to Nestlé Health Sciences SA, in a deal that underlines the potential of its approach to generating novel drugs from proteins expressed by gut bacteria. EM-1010, the first program derived from Enterome’s Endomimics platform, is an orally available molecule that acts by promoting local release of interleukin 10 (IL-10) in the gut, with the aim of reducing inflammation. It is in development for the treatment of inflammatory bowel disease and food allergies and due to enter clinical trials in 2023. Under the terms of the deal, Paris, France-based Enterome will receive €40 million (US$40.5 million) up front in cash and equity and is eligible for clinical and commercial milestones plus royalties if the drug makes it to market. In addition, Enterome will generate further Endomimics as part of the collaboration.

Japan Tissue Engineering’s autologous cultured cartilage receives full MHLW approval after 7 years

Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.

User fee dream a nightmare in the making?

A “clean” user fee bill with no congressionally added riders – that’s been a biopharma and med-tech dream for years. But now that U.S. Sen. Richard Burr (R-N.C.) has introduced such a bill, it could prove a nightmare, given the tight timetable for reauthorizing the user fee programs before the clock winds down on the current agreements Sept. 30. Burr’s Food and Drug Administration Simple Reauthorization Act is in reaction to what the senator dubbed as “anti-innovation amendments” the Senate Health, Education, Labor and Pensions Committee added to the bipartisan bill he and committee Chair Patty Murray (D-Wash.) had spent months drafting. It’s also a reaction to the partisan reconciliation package, with its drug pricing controls, that Democrats are pushing through Congress.

Also in the news

Adverum, Bone, Canbridge, Codexis, Cstone, Endo, Escend, Eyepoint, Gilead, Global Blood, Hutchmed, Immune-Onc, Immunocore, Kalivir Immunotherapeutics, Lantern, Moderna, N4, Neuropath, Neximmune, Novartis, Noxxon, Omega, Oncternal, Paladin Labs, Pfizer, Pliant, Polpharma, Prescient, Roche, Scholar Rock, Serb, Siga, Sinovac, Soligenix, TME, Voltron, Xequel