Roche’s Alzheimer’s drug failed to meet its goal in a long-awaited trial


  • Trials show small benefits but lack statistical power
  • Roche’s failure leaves Biogen and Eisai as the leaders in this field
  • Onus on Roche appointed to revive CEO-development fortunes
  • Roche shares fell 3.4%, development partner Morphosys fell 29%

Nov 14 (Reuters) – Roche’s ( ROG.S ) Alzheimer’s drug candidate failed to be shown to slow the progression of dementia in two drug trials, leaving rivals Biogen ( BIIB.O ) and Eisai ( 4523.T ) as top share leaders. race to start a cure for a memory-stealing disease.

Roche said in a statement on Monday that the twin studies, known as Graduate 1 and 2, did not reach their goal of showing that the drug gantenerumab can protect abilities such as memory, problem solving, orientation and personal care in patients suffering from the early stages of Alzheimer’s disease. disease.

The Swiss drugmaker conducted two studies of the same design with nearly 1,000 participants who were examined and questioned by doctors over a period of more than two years. In each study, volunteers were randomly assigned to receive either the injectable antibody drug gantenerumab or a placebo.

The drug was associated with a relative reduction in clinical decline of 8% at Study 1 and 6% at Study 2 compared with placebo, but these results were not statistically significant, the company said in a statement.

Credit Suisse analysts, who saw a 20% chance of the drug reaching $10 billion in annual sales, called the trial failure “unequivocal.”

Berenberg analysts put a 50% chance of gantenerumab hitting the $10 billion mark.

Roche shares fell 3.4% to an almost seven-week low.

Shares of U.S. drugmakers Biogen Inc ( BIIB.O ) and Eli Lilly and Co ( LLY.N ), which are developing rival treatments for Alzheimer’s disease, rose 3.8% and 2.3% respectively in premarket trading.

Analysts said the trial readout would affect stock market confidence in Roche’s research prowess, particularly after trials of lung cancer immunotherapy hope tiragolumab hit the company’s shares earlier this year.

“The development pipeline is a little too disappointing to keep the stock on the favorites list,” analysts at Luzerner Kantonalbank said in a research note.

Gantenerumab is designed to bind to aggregated forms of beta-amyloid and remove brain amyloid plaques, which are believed to play a crucial role in slowly progressive dementia.

The failure will be an added challenge for CEO-designate Thomas Schneeker, Roche’s head of diagnostics, who will be promoted in March. He will replace chief executive Severin Schwan, who led a successful campaign to shift Roche away from its traditional focus on cancer.

The quest to develop an Alzheimer’s drug that targets beta-amyloid or other molecules has been beset by a long list of research failures.

But Biogen scored a surprise trial success with an experimental Alzheimer’s drug it co-developed with Eisai in September, restoring confidence in its beta-amyloid approach among industry executives and researchers.

Biogen and Eisai said at the time that their drug candidate, lecanemab, slowed the progression of the brain-deteriorating disease by 27% compared with a placebo in a large trial of patients with early-stage Alzheimer’s.

Roche’s trial failure “removes the biggest competitive risk for lecanemab,” Baird analyst Brian Skorney said in a note.

The Swiss company’s formulation primarily targeted larger amyloid structures, while Biogen’s lecanemab targeted earlier stages of amyloid accumulation, among other differences in molecules and trial designs.

Roche released only the main results of the trials on Monday. He plans to present the details at the Alzheimer’s Disease Clinical Trials conference in San Francisco on November 30.

Rachelle Doody, Roche’s head of neurodegeneration, said she was very disappointed, adding that the trial’s measures of amyloid removal were also lower than expected.

“We’re going to show that there’s a relationship between amyloid reduction and clinical outcomes. It’s just that if you don’t get the amyloid reduction you expect, you’re not going to get the clinical outcome you expect,” he said. Reuters.

The Global Alzheimer’s Association said the reading, while disappointing, further demonstrates the link between beta-amyloid removal and slowing of clinical decline, but other research approaches should be considered.

“The future of Alzheimer’s treatment will be a combination of drugs that target different aspects of the disease at different times, as well as lifestyle interventions,” the statement said.

DIGONUS IS DIFFICULT

According to the World Health Organization, most of the 55 million people with dementia worldwide are likely to be affected by Alzheimer’s disease. In 2030, dementia is expected to affect 78 million people.

Alzheimer’s disease is difficult to diagnose, especially in its early stages.

Germany’s Morphosys ( MORG.DE ) would receive a tiered royalty of about 2% to 3% on future gantenerumab sales for its early role in developing the drug. Its shares fell 31%.

Royalty Pharma ( RPRX.O ) would have been entitled to about 3% to 4% of gantenerumab sales under a 2021 deal with Morphosys.

Data from a pivotal late-stage trial of Eli Lilly’s amyloid-targeting antibody drug donanemab is expected by mid-2023.

Report by Ludwig Burger in Frankfurt; Additional reporting by John Revill in Zurich and Khushi Mandowara in Bangalore; Edited by Christopher Cushing, Bradley Perrett, Kirsten Donovan, Sriraj Kalluvila, and Louise Heavens

Our standards: Thomson Reuters Trust Principles.



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