A ‘GAME-changing’ drug which could slow down Alzheimer’s disease is being considered for potential use on the NHS.
The daily medication, called hydromethylthionine mesylate (HMTM), was developed by British firm TauRX in Aberdeen.
HMTM works by preventing the build-up of tau protein clumps in the brain, which can damage neurons and lead to cognitive decline.
Regulators are set to make a decision on the drug in April.
If approved by both the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health and Care Excellence (Nice), it would mark the most significant advancement in NHS dementia treatment in decades.
The development follows the rejection of two other Alzheimer’s drugs earlier this year on cost grounds.
HMTM could offer significant cost advantages over existing treatments like lecanemab and donanemab, which require regular hospital visits for intravenous administration.
NHS officials believe the pill, that can be taken at home, could reduce healthcare costs compared to treatments requiring two or four-weekly hospital sessions.
The drug was developed from methylene blue, a medicine previously used to treat malaria.
Professor Alistair Burns, former NHS clinical director for dementia, called the trial results “great news for people with Alzheimer’s disease, their families and carers.
“We have reached an exciting time in the field of Alzheimer’s disease treatment.
“After no new therapies for a generation, we are on the threshold of having a range of new treatments, including a tau-targeted oral therapy, which have the real potential to slow the disease process.”
Trial results suggest HMTM has a better safety profile than other treatments, with fewer adverse side effects.
However, experts are divided on the drug’s effectiveness, with concerns about unpublished and non-peer-reviewed clinical trial data.
A source close to the regulatory process claimed TauRX had provided limited evidence beyond the drug’s effects of “making your urine turn green and your poo turn blue”.
The source added that the company’s case was “very difficult to understand” and appeared to be “trying to be complicated and confusing”.
The company has reportedly refused to accept previous trial results showing the drug performed no better than placebo.
This raises the possibility of HMTM becoming the third consecutive Alzheimer’s treatment to face NHS rejection.
At the Alzheimer’s Disease International conference in 2024, trial results showed no overall benefit over placebo on memory and cognitive decline, which the company attributed to unexpected placebo effects.
Dr Richard Oakley from Alzheimer’s Society noted that in a small subset of participants with mild cognitive impairment, HMTM showed beneficial effects.
He highlighted that HMTM didn’t cause the brain bleeding or swelling associated with drugs like donanemab or lecanemab.
However, Dr Oakley emphasised that without peer-reviewed publication of the phase 3 study results, it remains difficult to assess the drug’s effectiveness.
It comes after Donanemab was hailed as the “best ever” medicine for dementia after studies showed it slowed the memory-robbing illness by 35 per cent – better than any previous treatments.
It was given the green light by the Medicines and Healthcare Products Regulatory Agency (MHRA).
This means the medicine is safe and effective for people in the early stages of the disease and can now be prescribed privately in Britain for the first time.
But in a cruel twist, the NHS spending watchdog has ruled the benefits of the drug “too small” to justify the cost to the health service.
The draft guidance from the National Institute for Health and Care Excellence (NICE), means patients will only be able to get the drug from private clinics.
The decision on donanemab – the second drug found to slow the progress of Alzheimer’s disease – mirrors one taken in August when lecanemab, the first breakthrough treatment for the condition.
While experts have warned that dementia diagnoses in England have reached record numbers, there have been a number of recent advances against brain robbing diseases.
From “game-changing” drugs gaining approval to blood tests that can spot the condition years before symptoms, here are other major Alzheimer’s breakthroughs.
