CHICAGO (Reuters) – The biggest breakthrough in Alzheimer’s disease research in 30 years is spurring clinical trials of a ‘cocktail’ treatment that targets two distinct proteins associated with the mind-sapping disease , according to interviews with researchers and pharmaceutical company executives.
Pharmaceutical company Eisai Co., Ltd. (4523.T) and Biogen (BIIB.O)
reported in September that lecanemab therapy could slow disease progression by 27% over 18 months compared to placebo[read more[readmore][続きを読む[readmore
The findings test the theory that removing the amyloid protein, which forms clumps in the brains of Alzheimer’s patients, can slow or stop the disease’s progression, another infamous protein associated with Alzheimer’s disease. It has strengthened support from some scientists for simultaneously targeting tau.
Eisai and Biogen plan to present full data from the lecanemab trial at the Alzheimer’s Disease Clinical Trials Conference in San Francisco on Tuesday. The US Food and Drug Administration is expected to make a decision on the company’s accelerated approval application by early January.
If approved on an accelerated basis, the companies said they would immediately apply for full U.S. regulatory approval, which could help secure Medicare coverage. To date, two of her deaths have been reported in patients taking lecanemab in combination with drugs to prevent or clear blood clots, but industry analysts do not believe these developments alone will prevent approval. Is not …read more
“I think lecanemab has reinvigorated the idea that amyloid[and]tau can be combined,” Reisa Sperling, Ph.D., a neurologist and Alzheimer’s disease researcher at Harvard Medical School, said in an interview. Told.
Tau naturally accumulates as we age in the memory center of the brain called the medial temporal lobe. A growing body of research suggests that elevated amyloid levels in Alzheimer’s patients act as facilitators, triggering an explosive spread of tau that forms toxic tangles within brain cells, ultimately killing them.
“We’ve been trying combination trials for years,” said Sperling. Almost a decade ago, Alzheimer’s disease experts met in Washington to discuss trials of combination therapies. At the time, “no one listened,” she said.
But now, Sperling and other researchers at the Alzheimer’s Disease Clinical Trials Consortium (ACTC), a research network supported by the National Institute on Aging (NIA), are investigating studies in which drug companies will test tau drugs alone or in combination. said they are increasingly interested in participating in Anti-amyloid drugs such as lecanemab.
Dr. Paul Eisen, Director of the Alzheimer’s Disease Treatment Institute at the University of Southern California, Keck, said: M.D., leader with ACTC sparring.
Scientists said they hoped to get an answer on funding by the end of the year. The National Institutes of Health, which oversees the NIA, said it would not discuss the grant under review.
spent billions
According to congressional briefing documents, more than 6 million Americans have Alzheimer’s disease, costing the U.S. economy nearly $6 billion in direct spending and unpaid care costs annually. Alzheimer’s patients are expected to double to 12.7 million by 2050, with total annual costs of nearly $1 trillion, according to the document.
Last year, the FDA granted conditional approval to Biogen and Eisai’s drug aducanumab, but one of two late-stage trials failed. Approval was based on the drug’s ability to clear amyloid from the brain.
Biogen initially priced the drug at $56,000 annually, but the U.S. Centers for Medicare and Medicaid Services said more compelling evidence was needed, and Medicare would only sell the drug for use in clinical trials. Said to cover.
The success of lecanemab rests on years of research into the causes of Alzheimer’s disease and advances in brain scans and spinal fluid measurements of amyloid deposits. Tau drug trials are using brain scans, spinal fluid, and blood tests to better assess the stage of the disease, when to intervene, and whether the drug is reaching its targets, thus improving its effectiveness. It is meant to build on progress. This will allow companies to test drugs even before symptoms appear.
Nearly a dozen pharmaceutical companies, including Roche (ROG.S)Merck & Co. (MRK.N)Johnson & Johnson (JNJ.N) and Eli Lilly and Co.(LLY.N)are working on tau-targeted therapies. At least 16 treatments are being tested in clinical trials, with results expected in the next three years, according to a Reuters look at his Clinicaltrials.gov registry.
Merck is testing MK-2214 therapy, which aims to clear tau in patients in the very early stages of the disease, in several small trials.
Jason Uslaner, Head of Discovery Neuroscience at Merck, said: Pharmaceutical companies have all but disappeared from the Alzheimer’s arena after the high-profile failure of its drug vervecestat five years ago.
So far, only a few trials have combined amyloid-lowering therapy with tau-targeted drugs in a ‘cocktail’ approach similar to that used against cancer and HIV.
Such a combination could improve the benefits of lowering amyloid alone in symptomatic people, researchers told Reuters. It is hoped that it will be possible to prevent
“It may be necessary to both remove the amyloid driving that biological cascade and clear the tau that has already spread from one cell to another.” San Francisco, California (UCSF) ) Memory and Aging Center.
But some antibody therapies from Lilly, Biogen, and AbbVie(ABBV.N) One designed to slow the rate of tau accumulation failed completely last year. Roche’s semolinemab drug had limited efficacy.
“It took maybe 20 or 30 years to find a drug that actually targeted amyloid in the right form to make a difference,” Boxer said. “It’s still early days.”
Reporting by Julie Steenhuysen.Edited by Michele Gershberg and Suzanne Goldenberg
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