Alzheimer’s Drug From Roche Fails in Late-Stage Trials

“So many of our families have been directly affected by Alzheimer’s, so this news is very disappointing to deliver,” said

Levi Garraway,

Roche’s chief medical officer. In one trial, gantenerumab reduced cognitive and functional decline by 8% and in the other, the reduction was 6%. Neither result passed the threshold for statistical significance, the Swiss company said. Roche shares were down nearly 5% in morning trading.

The news comes just weeks after clinical trial results from a drug developed jointly by

Biogen Inc.

and

Eisai Co.

infused fresh hope into a field that has been marked by failure. The Biogen and Eisai drug, called lecanemab, reduced cognitive and functional decline by 27% compared with a placebo. The companies say they plan to provide more detailed study results at an upcoming research conference.

Like lecanemab, Roche’s gantenerumab targets accumulations of beta-amyloid, a protein that is found in the brains of people with Alzheimer’s and is thought to be linked to the disease. Several earlier beta-amyloid-targeting drugs had failed in clinical trials, although each drug acts slightly differently.

Roche Chief Executive

Severin Schwan

said last month that the Biogen and Eisai results were encouraging, but cautioned that they didn’t shed any light on the likely success of gantenerumab. Roche said Monday that the level of beta-amyloid removal by gantenerumab was lower than expected in the trials.

Rachelle Doody, global head of neurodegeneration at Roche, said in an interview that the trials, while unsuccessful, bolstered the theory that removing beta-amyloid has some effect on symptoms of Alzheimer’s given both showed a reduction in cognitive decline, albeit a small one.

Therapies that reduce beta-amyloid at the right time are likely to play a role in tackling Alzheimer’s, Dr. Doody said, though they would need to work in combination with other approaches. “Amyloid will remain part of the picture,” she said.

Dr. Doody said Roche would end trials testing gantenerumab in the early Alzheimer’s population. The company is also testing gantenerumab as a preventative treatment in people at high risk of developing Alzheimer’s, and will make a decision on the future of those trials by the end of the year, she said. Roche is also testing a version of gantenerumab that is designed to better access the brain.

The Alzheimer’s research field is littered with failures. Those setbacks were compounded last year when Aduhelm, the first drug to be approved for Alzheimer’s in almost two decades, was refused routine coverage by Medicare because of a lack of evidence that it benefited patients. The decision effectively cut off access for most Alzheimer’s patients in the U.S.

Aduhelm, also developed by Biogen and Eisai, was last year granted accelerated approval by the Food and Drug Administration after trial data showed the drug reduced the levels of beta-amyloid in the brain.

But the FDA’s move drew criticism from some experts who said the drug’s clinical trial results weren’t conclusive. Medicare’s decision not to routinely cover the drug prompted Biogen to stop marketing it.

Alzheimer’s researchers say the causes of the disease are likely complex and that countering it will likely require a multipronged approach. Some drugmakers, including Roche, are testing drugs that target tangles of tau, another protein that is found in the brains of people with Alzheimer’s.

Write to Denise Roland at [email protected]

“So many of our families have been directly affected by Alzheimer’s, so this news is very disappointing to deliver,” said

Levi Garraway,

Roche’s chief medical officer. In one trial, gantenerumab reduced cognitive and functional decline by 8% and in the other, the reduction was 6%. Neither result passed the threshold for statistical significance, the Swiss company said. Roche shares were down nearly 5% in morning trading.

The news comes just weeks after clinical trial results from a drug developed jointly by

Biogen Inc.

and

Eisai Co.

infused fresh hope into a field that has been marked by failure. The Biogen and Eisai drug, called lecanemab, reduced cognitive and functional decline by 27% compared with a placebo. The companies say they plan to provide more detailed study results at an upcoming research conference.

Like lecanemab, Roche’s gantenerumab targets accumulations of beta-amyloid, a protein that is found in the brains of people with Alzheimer’s and is thought to be linked to the disease. Several earlier beta-amyloid-targeting drugs had failed in clinical trials, although each drug acts slightly differently.

Roche Chief Executive

Severin Schwan

said last month that the Biogen and Eisai results were encouraging, but cautioned that they didn’t shed any light on the likely success of gantenerumab. Roche said Monday that the level of beta-amyloid removal by gantenerumab was lower than expected in the trials.

Rachelle Doody, global head of neurodegeneration at Roche, said in an interview that the trials, while unsuccessful, bolstered the theory that removing beta-amyloid has some effect on symptoms of Alzheimer’s given both showed a reduction in cognitive decline, albeit a small one.

Therapies that reduce beta-amyloid at the right time are likely to play a role in tackling Alzheimer’s, Dr. Doody said, though they would need to work in combination with other approaches. “Amyloid will remain part of the picture,” she said.

Dr. Doody said Roche would end trials testing gantenerumab in the early Alzheimer’s population. The company is also testing gantenerumab as a preventative treatment in people at high risk of developing Alzheimer’s, and will make a decision on the future of those trials by the end of the year, she said. Roche is also testing a version of gantenerumab that is designed to better access the brain.

The Alzheimer’s research field is littered with failures. Those setbacks were compounded last year when Aduhelm, the first drug to be approved for Alzheimer’s in almost two decades, was refused routine coverage by Medicare because of a lack of evidence that it benefited patients. The decision effectively cut off access for most Alzheimer’s patients in the U.S.

Aduhelm, also developed by Biogen and Eisai, was last year granted accelerated approval by the Food and Drug Administration after trial data showed the drug reduced the levels of beta-amyloid in the brain.

But the FDA’s move drew criticism from some experts who said the drug’s clinical trial results weren’t conclusive. Medicare’s decision not to routinely cover the drug prompted Biogen to stop marketing it.

Alzheimer’s researchers say the causes of the disease are likely complex and that countering it will likely require a multipronged approach. Some drugmakers, including Roche, are testing drugs that target tangles of tau, another protein that is found in the brains of people with Alzheimer’s.

Write to Denise Roland at [email protected]