Lilly drug slows Alzheimer's by 35%

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Written by northsouth

Category: Science

Published: 04 May 2023

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CHICAGO - An experimental Alzheimer's drug developed by Eli Lilly and Co slowed cognitive decline by 35% in a late-stage trial, the company said on Wednesday, providing what experts say is the strongest evidence yet that removing sticky amyloid plaques from the brain benefits patients with the fatal disease.

Lilly's drug, donanemab, met all goals of the trial, the company said. It slowed progression of Alzheimer's by 35% compared to a placebo in 1,182 people with early-stage disease whose brains had deposits of two key Alzheimer's proteins, beta amyloid as well as intermediate levels of tau, a protein linked with disease progression and brain cell death.

The study also evaluated the drug in 552 patients with high levels of tau and found that when both groups were combined, donanemab slowed progression by 29% based on a commonly used scale of dementia progression known as the Clinical Dementia Rating Scale (CDR-SB).

Using that scale, experts said Lilly's findings were roughly on par with Eisai Co Ltd and Biogen Inc's lecanemab, sold under the brand name Leqembi, which reduced cognitive decline by 27% in patients with early Alzheimer's in a study published last year.

The results drove Lilly's shares to a record high, up more than 6% at $429.85.

Dr. Ronald Petersen, an Alzheimer's researcher at Mayo Clinic, said Lilly's trial is the third to show removing amyloid from the brain slows progression of the disease, which could put to rest some lingering doubts about the benefits of drugs in the class and the amyloid-lowering theory.

"It's modest, but I think it's real," he said of the benefit, "and I think it's clinically meaningful."

Dr. Erik Musiek, a Washington University neurologist at Barnes-Jewish Hospital, said the efficacy looks as good or better than lecanemab.

"The evidence is really starting to build up that these drugs do work," he said.

Musiek said the findings also offer some of the first evidence for the benefit of earlier treatment. "It really does suggest that you need to remove these plaques early, before the tau really gets going," he said.

'RISK THAT NEEDS TO BE CONSIDERED'

In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of participants, with 6.1% experiencing symptoms. Brain bleeding occurred in 31.4% of the donanemab group and 13.6% of the placebo group.

In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants.

Lilly said the incidence of serious brain swelling in the donanemab study was 1.6%, including two deaths attributed to the condition, and a third, after an incident of serious brain swelling.

A research note by SVB Securities analyst David Risinger was headlined: "Donanemab Succeeds, But Safety Remains a Concern".

"Clearly, one saw benefits here, but there is some risk that needs to be considered," said Dr. Eric Reiman, executive director of the Banner Alzheimer's Institute, which is running a study of donanemab in presymptomatic patients.

Lilly said it plans to file for traditional U.S. approval by the end of June, and with regulators from other countries shortly thereafter. A company spokesman said a U.S. approval decision should come by year-end or early 2024.

Alzheimer's experts said they were eager to see full results of the study, including data on how the drug performs in people who carry an Alzheimer's risk gene known as APOE4, who have been prone to increased risk of side effects in prior trials.

Those results are set to be presented at an Alzheimer's meeting in Amsterdam this summer.

Study participants received a monthly intravenous infusion of donanemab. At 12 months, half had no evidence of amyloid plaques, the company said.

It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

Lilly's drug is poised to become the third in its class on the market following U.S. approval of two similar medicines developed by partners Eisai and Biogen - Leqembi as well as Aduhelm, which failed to gain traction with doctors or insurers after showing little evidence that it slowed cognitive decline.

Both were approved under the FDA's accelerated review program, based on their ability to remove amyloid plaques.

Leqembi is currently undergoing the FDA's standard reviewprocess, with a decision due by July 6.

Lilly is still working on finalizing the price for donanemab, and plans for it to be in the same range as other similar therapies, CEO David Ricks told CNBC.

More than 6 million Americans are living with Alzheimer's,and that number is projected to rise to nearly 13 million by 2050, according to the Alzheimer's Association.

New Alzheimer’s drug hailed as ‘beginning of the end’

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Written by northsouth

Category: Science

Published: 30 November 2022

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LONDON - Experts have hailed the “beginning of the end” in the search for effective Alzheimer’s treatments after a new drug reduced memory decline among patients with early stages of the disease.

Lecanemab, which is designed to target and clear amyloid – one of the proteins that builds up in the brains of people with Alzheimer’s – was found to slow decline in patients’ memory and thinking.

The phase three clinical trial results have been reported by Eisai, a Tokyo-based pharmaceutical company that has partnered with US biotech firm Biogen to develop lecanemab.

Eisai reported initial results in September from a trial on 1,795 participants with early Alzheimer’s disease.

Scientists found that after 18 months the drug slowed the disease progression by 27% compared with patients taking the placebo.

Full results from the study have since been published in The New England Journal of Medicine, with experts hailing it as long-awaited proof that Alzheimer’s disease can be treated.

“This trial is an important first step, and I truly believe it represents the beginning of the end,” said Professor John Hardy, group leader at the UK Dementia Research Institute at University College London.

“The amyloid theory has been around for 30 years so this has been a long time coming. It’s fantastic to receive this confirmation that we’ve been on the right track all along, as these results convincingly demonstrate, for the first time, the link between removing amyloid and slowing the progress of Alzheimer’s disease.

“The first step is the hardest, and we now know exactly what we need to do to develop effective drugs. It’s exciting to think that future work will build on this, and we will soon have life-changing treatments to tackle this disease.”

Prof Bart De Strooper, director at the institute, added: “The overall conclusion is extremely positive. This trial proves that Alzheimer’s disease can be treated.”

Prof Nick Fox, director of the Dementia Research Centre, said: “I believe, it confirms a new era of disease modification for Alzheimer’s disease.

“An era that comes after more that 20 years of hard work on anti-amyloid immunotherapies – by many many people – and many disappointments along the way.”

Dr Richard Oakley, associate director of research at Alzheimer’s Society, said the results had the potential to be “game-changing”.

“They give us hope that in the future people with early Alzheimer’s disease could have more time with their loved ones,” he said.

However, experts warned that UK officials have much to do to prepare to deliver the drug, provided it gets regulatory approval.

There are two ways to tell whether there is amyloid on the brain – a brain scan or biomarker test which is currently done through lumbar puncture.

While a blood test is on the horizon, dementia services must rely on current tests which are expensive and can have big waiting lists.

Private patients and those living near to big dementia services can access these diagnostic tests, but the vast majority of the public cannot, experts said.

They warned that unless there are big changes in diagnostic services, people could become ineligible for lecanemab treatment while on the waiting list for diagnosis because it can only be given to patients with mild disease – if their disease progresses to a moderate stage while on the waiting list, they will no longer be eligible for treatment.

Prof De Strooper said: “The participants of this trial were all people with very early-stage Alzheimer’s disease, which raises the question of how we ensure that people can access these drugs at the right stage in their disease course.

“In parallel, we must focus on making early diagnosis easier and more accessible, so that treatments can be administered when they are most likely to have a positive impact, before amyloid levels are too high and start to cause damage to the brain.”

Experts also stressed that more work still needed to be done to investigate the drug’s side effects.

“The trial results have shown us that there is a risk of side effects, including brain bleeds in a small number of cases,” Prof Hardy said.

“This doesn’t mean the drug can’t be administered, but that will be important to have rigorous safety monitoring in place for people receiving lecanemab, and further trials to fully understand and mitigate this risk.”

Scientists may have found something massive living under Antarctica

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Written by northsouth

Category: Science

Published: 26 November 2022

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LONDON - The new study was published on Nov. 17 in 'Frontiers'. Researchers say they've discovered a living world beneath the ice in Antarctica that may span 5 million square kilometers.

Climate change is currently posing a massive risk to the ice shelves down in Antarctica, which has only fueled research in the area to increase more and more, and for good reason. Now, a group of scientists working in the southernmost region of our planet has discovered something massive living under Antarctica.

According to a study published in Frontiers in Marine Science, researchers have discovered a massive living world below Antarctica’s icy surface that could be as big as 5 million square kilometers. This continent is often thought of as having a hostile climate and has been ground zero for the changes that rising global temperatures bring.

For decades, scientists have studied the photosynthetic algae that forms around Antarctica in the summer months, believing that it only emerges when the ice has melted, giving way for sunlight to reach the algae. Now, though, it appears that something massive may be living under Antarctica even when the ice isn’t melted.

The research suggests that there could still be a massive amount of these algae living permanently underneath the ice that covers the continent. Essentially, that would put a massive world living under the Antarctic ice, which is insane to think about considering how hostile we believe that area of the world to be because of its low, freezing temperatures.

For decades, scientists have believed that nothing could live under the frozen surface of Antarctica. As such, the possibility of this discovery challenges everything we know about that region of our world. And, with more research, we could discover even more living under Antarctica.

Seals, penguins, and other animals acclimated to that region still survive here, but the fact that other life might is quite impressive, especially when you consider how often algae and plankton rely on the energy from the Sun to thrive. The current belief is that holes in the icy southern ocean could give the algae enough sunlight to power through the colder months of the year.