Developing Therapies to Treat Aging is No Less Challenging than Other Areas of Biotech

The biotech industry experiences a high failure rate, if we wish to define failure as failing to achieve the original goals of the research program that gave rise to a company. The article noted here opens with many examples to give a sense of the prevalence of companies in the early aging-focused space that altered their course to give a return to their investors by other means, after it proved too challenging to achieve the original vision. This is par for the course: the development of novel medical biotechnology is both very difficult and highly regulated. The grail of producing new medicine that is accepted by the regulatory community is a rare success, but it is also true that there are other paths to generating some progress from programs that fail to achieve that goal.

The different strategies that past companies followed are common answers to the same constraint: there is no regulatory pathway to bring geroprotectors the market. So they either: (a) Develop pre-clinical assets and platform that may have value for other pharmaceutical and biotech companies. (b) Commit to the traditional biotech playbook and treat an age-related disease through a drug that targets a specific pathway or mechanism of aging, collect data to support claims for other indications and expand the label of the medicine over time. (c) Commercialise unproven products (supplements) or experimental treatments (gene therapies) in jurisdictions where the regulatory environments may allow such procedures.

The intrinsic scientific difficulties in translating early stage research into an approved treatment often stood in the way of commercialisation, despite the best efforts of companies and researchers. Some assets got acquired and abandoned and others are still on their path to the clinic. In a perfect world, nobody would forget on the shelf an asset that has the potential to slow down aging. But many factors beyond just the science can influence whether an asset continues along the development pipeline. Even the most promising early research can sometimes fail to translate into an approved product, due to the inherent challenges in drug development.

The company pivots to a different therapeutic area and the asset is no longer core to their strategy. Leadership changes at the company and new decision makers have different priorities, so they discontinue programs started under previous leaders. Patent life expires before the asset has progressed far enough to merit continued investment. Another company develops a similar or superior asset that displaces interest in theirs. The company runs out of funding to progress all assets and must make tough choices about which programs to shelve. Leadership simply loses conviction in the asset's potential for unclear reasons and turns attention elsewhere.

It may be possible to treat an age-related disease by targeting a mechanism of aging and I'm confident some companies will achieve that relatively soon. From an investment and commercial perspective, given the scientific and historical risks, a drug that targets a specific pathway or mechanism of aging to treat a disease has no superior value than any other drug. Unless that drug can slow down aging. But in more than 30 years, despite apparently promising science and significant funding raised, no single longevity biotech startup has succeeded to bring a product to market. Product as in: drug that has been approved by a regulatory agency following thorough clinical trials. So maybe it's time to consider a different strategy: assume the regulatory risk, target aging itself and be preventive instead of curative. Preventive drugs approved for several indications already exist. So bringing to market drugs that slow down the aging process and prevent all age-related diseases is just one step away.


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