Conditional approval for new Alzheimer’s drug

A new Alzheimer’s therapy has been granted conditional approval in China.

Conditional approval for new Alzheimer’s drug

It’s been almost two decades since any Alzheimer’s drug was approved, but a new compound has now been granted conditional approval in China.

Decades of research has failed to deliver any concrete developments, but drug maker Shanghai Green Valley Pharmaceuticals has reported positive results from a phase three trial involving about 800 Alzheimer’s patients.

The company said its drug, Oligomannate, which is derived from seaweed, improved cognitive function in patients with mild to moderate Alzheimer’s compared to placebo participants, “with benefits seen in patients as early as week four and persisting throughout the 36 weeks of the trial”.

The announcement has been met with caution and an eagerness from clinicians around the world to see the full data.

Complete trial results have not yet been made available, but the conditional approval for Oligomannate could mean it will be on the market in China by the end of the year, statnews.com reports.

Reuters says the next step for Green Valley is to submit additional research on the drug’s long-term safety and effectiveness to China’s National Medical Products Administration.

Meanwhile, Green Valley says it will launch a global phase three trial next year with the aim of marketing the product outside China.

Alzheimer’s Research UK research director Carol Routledge said in a statement: “It’s good to see that drug regulators in China are prioritising emerging treatments for Alzheimer’s, but we do still need to see more evidence that this drug is safe and effective. For any potential drug to gain a stamp of approval by regulators in the UK, we’ll need to see larger trials in countries around the world to back up the evidence from China.”

Other international experts said they were keen to examine the complete data to see how cognitive function improved for patients on the drug as opposed to those on the placebo.

Statnews.com says that Oligomannate was developed “to modulate the connection between the brain and the bacterial communities in the gut known as the microbiome”. This is in contrast to other research which has been seeking a way to sweep away protein build-up in the brain.

“The connection between the microbiome and overall health is the subject of a relatively new and evolving field of research, with some scientists seeking to understand how bacteria can influence the emergence of disease, including Alzheimer’s,” the report says.

Alzheimer’s Association’s chief science officer Maria Carrillo said the development of Oligomannate reflected how the field had expanded beyond drugs that targeted the accumulation of protein in the brain and was “the first necessary step toward a combination approach to treat Alzheimer’s dementia and all dementia.”

Dr Joy Snider, a neurologist at Washington University in St Louis, said she hoped the next trial would include more people than the roughly 800 enrolled in the earlier phase three trial.

“We’re always excited to have a new potential treatment,” Dr Snider said, “but I certainly would not prescribe it to my patients based on a single study or another country’s approval until we know more about it.”

Dr Jeffrey Cummings, of the Cleveland Clinic, has been an adviser to Green Valley for about two years. He said: “We are in a period of global innovation that we’re not quite used to. This is a global disease and a challenge to the health and dignity of the elderly around the world.

“We need to be open to these ideas at the same time as we need to hold them to a thorough level of scrutiny.”

Would you be prepared to try this drug based on the existing trials?

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    COMMENTS

    To make a comment, please register or login
    KSS
    7th Nov 2019
    2:34pm
    Far more evidence is needed. This may be 'promising' but Australia's TGA woould need a whole lot more data to consider listing it here.
    musicveg
    7th Nov 2019
    11:47pm
    Interesting it is derived from seaweed, maybe it is the iodine in seaweed or the many nutrients in seaweed.


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