- Trials show small benefit, but without statistical validity
- Roche setback leaves Biogen and Eisai as leaders in the field
- It’s up to Roche’s CEO-designate to revive development fortunes
- Roche shares down 3.4%, its development partner Morphosys down 29%
Nov 14 (Reuters) – Roche’s (ROG.S) drug candidate for Alzheimer’s disease has not been shown to slow the progression of dementia in two drug trials, leaving rivals Biogen (BIIB.O) ) and Eisai (4523.T) leading a high-stakes race to launch a treatment for the disease that steals memory.
Roche said in a statement Monday that the twin studies known as Graduate 1 and 2 failed to achieve their primary goal of showing that the drug gantenerumab can preserve abilities such as memory, problem solving, guidance and personal care in patients with the early stages of Alzheimer’s disease. sickness.
The Swiss drugmaker conducted two studies of identical design, each with around 1,000 participants, who were examined and interviewed by doctors for more than two years. In each study, volunteers were randomly assigned to receive either the injectable antibody gantenerumab or a placebo.
The drug was associated with a relative reduction in clinical decline of 8% in Graduates 1 and 6% in Graduates 2 compared to placebo, but these results were not statistically significant, the company said in a statement.
Credit Suisse analysts, who had seen a 20% chance of the drug hitting peak annual sales of $10 billion, called the trial’s failure “unequivocal”.
Berenberg analysts had estimated a 50% chance of gantenerumab hitting the $10 billion peak.
Shares of Roche fell 3.4% to their lowest level in nearly seven weeks.
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 pre-market trade.
Analysts said reading the trial would impact the stock market’s confidence in Roche’s research prowess, particularly after hopeful lung cancer immunotherapy tiragolumab failed in a trial. trials earlier this year, beating the company’s stock.
“The development pipeline has disappointed a little too often to keep the title on a favorites list,” Luzerner Kantonalbank analysts said in a research note.
Gantenerumab was designed to bind to aggregated forms of beta-amyloid and clear brain amyloid plaques, which are thought to play a crucial role in slowly progressing dementia.
The setback will be an additional challenge for CEO-designate Thomas Schinecker, Roche’s head of diagnostics, who will be promoted in March. He will replace Severin Schwan, the chief executive who led a successful campaign to diversify away from Roche’s traditional focus on cancer.
The quest to develop a drug for Alzheimer’s disease, targeting beta-amyloid or other molecules, has been beset by a long list of failed studies.
But Biogen won a surprise trial in September with an experimental Alzheimer’s drug it developed with Eisai, restoring faith among industry executives and researchers in the beta-amyloid approach.
Biogen and Eisai said at the time that their drug candidate, lecanemab, slowed disease progression of cerebral atrophy by 27% compared to a placebo in a large trial of patients in the early stages of the disease. of Alzheimer’s.
Roche’s trial failure “removes the greatest competitive risk for lecanemab,” Baird analyst Brian Skorney said in a note.
The Swiss company’s compound primarily targeted larger amyloid structures, while Biogen’s lecanemab targeted early stages of amyloid accumulation, among other differences in molecules and trial designs.
Roche released only the main trial result on Monday. He plans to present detailed data at the Alzheimer’s Disease Clinical Trials Conference in San Francisco on Nov. 30.
Rachelle Doody, head of neurodegeneration at Roche, said she was very disappointed, adding that the amyloid removal trial measurements also fell short of expectations.
“We will show that there is a relationship between amyloid reduction and clinical outcomes. It’s just that when you don’t get the amyloid reduction you expected, you won’t get the clinical outcome you expected,” she said. Reuters.
The World Alzheimer’s Association said the reading, while disappointing, further illustrated the relationship between amyloid-beta clearance and slowing clinical decline, but other research approaches should be considered.
“The future of Alzheimer’s disease treatment will be a combination of drugs that target different aspects of the disease at different times, along with lifestyle interventions,” he said in a statement.
DIFFICULT TO DIAGNOSE
Most of the 55 million people with dementia worldwide are at risk for Alzheimer’s disease, according to the World Health Organization. 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) has reportedly received tiered royalties of around 2% to 3% on future sales of gantenerumab since its early role in developing the drug. Its shares plunged 31%.
Royalty Pharma (RPRX.O) would have been entitled to around 3% to 4% of gantenerumab sales under a 2021 deal with Morphosys.
Data from a key late-stage trial of donanemab, Eli Lilly’s amyloid-targeting antibody, is expected by mid-2023.
Reporting by Ludwig Burger in Frankfurt; Additional reporting by John Revill in Zurich and Khushi Mandowara in Bengaluru; Editing by Christopher Cushing, Bradley Perrett, Kirsten Donovan, Sriraj Kalluvila and Louise Heavens
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