Better with metformin? (Image: Plainpicture)
ANTI-AGEING pills are no longer drugs of the future 鈥� the first trial in people could begin as early as next year.
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Last month, the scientists behind the trial began talks with the US Food and Drug Administration to hammer out the practicalities. The trial aims to test whether a diabetes drug called metformin also delays death and age-related conditions such as heart disease, cancer and mental decline.
It would be the first time a medicine has been tested specifically for delaying ageing in a human trial. 鈥淚t鈥檚 groundbreaking,鈥� says Sue Peschin of the US-based non-profit organisation . 鈥淚t鈥檚 significant that the FDA has opened their doors to researchers about the idea.鈥�
鈥淚t鈥檚 groundbreaking. This is the first time a drug has been tested for delaying ageing in humans鈥�
For a long time the field of lifespan extension has had a flaky reputation, with most of the ideas mooted being either unappealing or impractical, such as near-starvation diets or somehow lengthening the tips of our chromosomes.
Drug regulators do not even officially recognise ageing as a condition in need of treatment, which could make it hard to get medicines approved. But this isn鈥檛 an insurmountable problem and repurposing an existing drug could help, because we already have long-term safety data.
Metformin has been used to treat type 2 diabetes for decades. That means the researchers could go straight to large-scale testing in people. New drugs typically have to be tested on animals first and then small groups of people. This one aims to follow 3000 people in their 70s for five years, and positive results should be enough for the FDA to approve it, says lead researcher of the Albert Einstein College of Medicine in New York.
The chief hurdle is a lack of funding, to the tune of $50 million. The is supporting the planning stages, and the team is in talks with several potential backers, including the US National Institutes of 午夜福利1000集合, so Barzilai is confident. 鈥淲e have interest from multiple sources, so one way or another this trial is going on,鈥� he says. After all, if the drug is approved, there is likely to be huge demand for it.
After meeting with the FDA in June, Barzilai says the regulator had only 鈥渕inor suggestions鈥� and was supportive in principle. The trial does not actually need FDA permission to go ahead, but talking to the agency now means it can be designed to smooth the path to licensing later on.
To begin the trial, all Barzilai needs is the go-ahead from the various ethics committees involved. He says this should be relatively easy as metformin is seen as such a safe drug.
The compound helps people with diabetes by reducing how much glucose the liver makes. Its most common side effects are nausea and diarrhoea, but these can be lessened by raising the dose slowly and taking it with meals.
Interest in metformin鈥檚 possible anti-ageing effects arose because diabetics taking the drug have lower rates of cancer and heart disease and, in one study, .
The explanation is unclear as the compound has multiple effects on cells but one theory is that it mimics the effects of calorie restriction, which delays ageing in many animals. When food is scarce, cells shift into energy-conserving mode, and this seems to have knock-on effects on lifespan.
The proposed metformin trial is not the only sign of progress in the anti-ageing field. This month a trial in dogs is due to begin of a drug called rapamycin. This is already used in people to suppress the immune system, for example, after an organ transplant, but at lower doses it may also mimic calorie restriction.
Unusually, the study鈥檚 subjects are not lab animals but , partly to reduce the time and expense of a trial involving large, long-lived animals. Team member of the University of Washington in Seattle thinks that dogs could gain an extra two to five years of life.
The work will likely be popular, Peschin says: 鈥淚t鈥檚 going to have a warm and fuzzy effect that mice studies simply don鈥檛 have鈥� 鈥� which may help attract money for follow-up work.
of the University of Brighton, UK, who researches the mechanisms of ageing, another recent boost to the field has been the arrival of drug giant Novartis. Last year the firm reported results showing an anti-ageing effect in a drug called everolimus, which works in a similar way to rapamycin.
It was a trial of the medicine鈥檚 ability to enhance older people鈥檚 response to flu vaccination 鈥� which it did 鈥� but it also suggests that the drug could prolong life by reducing the normal decline of the immune system with age.
Faragher thinks Novartis鈥檚 involvement shows anti-ageing is a field to be taken seriously. 鈥淲e are not trying to be immortal,鈥� he says. 鈥淎ll we are trying to do is make sure that we have some extra years without disease.鈥�
Not just for old people
While the first planned test of metformin as an anti-ageing pill will be in people over 70, the benefits might be maximised by starting it earlier in life.
But there鈥檚 a stumbling block in the way of testing life-extending drugs in young or middle-aged people. Because they are likely to be healthy, it could take decades to see a drop in their rates of death or disease. One option is to measure their rate of ageing using blood tests to pick up age-related chemicals like cholesterol, and measurements such as blood pressure.
This week, researchers at Duke University in North Carolina reported that of a group of 1000 New Zealanders. Although they were all 38, the test revealed that their biological ages ranged from 28 to 61. 鈥淣ow we have tools to validate how well [anti-ageing] therapies work in a much shorter timescale,鈥� says co-author .
This article appeared in print under the headline 鈥淭he age of the longevity drug鈥�
