- The trial showed a small benefit, but without statistical validity
- Roche’s setback leaves Biogen, Eisai as the leader in the field
- Onus on Roche CEO-designate to revive development fortunes
- Roche shares down 3.4%, development partner Morphosys down 29%
Nov 14 (Reuters) – Roche’s (ROG.S) The Alzheimer’s drug candidate could not be shown to slow the progression of dementia in two drug trials, leaving rival Biogen behind (BIIB.O) and Eisai (4523.T) as the leader in the high-stakes race to launch a cure for the memory-robbing disease.
Roche said in a statement on Monday that the twin studies known as Graduate 1 and 2 have not yet achieved the main goal of showing that the drug gantenerumab can preserve abilities such as memory, problem solving, orientation and personal care in patients suffering from the early stages of Alzheimer’s. disease
The Swiss drugmaker held two identically designed studies, each with about 1,000 participants, who were examined and queried by doctors for 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% in Postgraduate 1 and 6% in Postgraduate 2 compared to placebo, but the results were not statistically significant, the company said in a statement.
Credit Suisse analysts, who have seen a 20% chance of the drug reaching the peak annual sales of $10 billion, described the failure of the trial as “obvious”.
Berenberg analysts have put a 50% chance of gantenerumab reaching the $10 billion peak.
Roche shares fell 3.4% to their lowest in nearly seven weeks.
Changes in the share price of US drugmakers Biogen Inc (BIIB.O) and Eli Lilly and Co (LLY.N)which is developing a rival treatment for Alzheimer’s, up 3.8% and 2.3%, respectively, in premarket trading.
Analysts said readings from the trial would affect stock market confidence in Roche’s research capabilities, especially after lung cancer immunotherapy hope tiragolumab fell in trials earlier this year, hitting the company’s stock.
“The development pipeline has disappointed a bit too often to keep the stock in the list of favorites,” said the analyst at Luzerner Kantonalbank in a research note.
Gantenerumab is designed to bind to the aggregated form of amyloid beta and remove brain amyloid plaques, which are believed to play an important role in slowly progressive 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 succeed Severin Schwan, the chief executive who has led a successful campaign to diversify away from Roche’s traditional focus on cancer.
Attempts to develop Alzheimer’s drugs, targeting beta-amyloid or other molecules, have been dogged by a long list of study failures.
But Biogen in September scored a surprise trial success with an experimental Alzheimer’s drug developed with Eisai, rebuilding confidence among industry executives and researchers in the beta-amyloid approach.
Biogen and Eisai said at the time that their drug candidate lecanemab had slowed the progression of the brain-related disease by 27% compared to a placebo in a large trial of patients in the early stages of Alzheimer’s.
The failure of the Roche trial “takes on the biggest competitive risk for lecanemab,” Baird analyst Brian Skorney said in a note.
The Swiss company’s compound primarily targets larger amyloid structures while Biogen’s lecanemab targets the early stages of amyloid formation, among differences in molecules and trial design.
Roche only released the main results of the trial on Monday. It plans to present the full data 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 size of the amyloid removal trial was also lower than expected.
“We’re going to show that there’s a relationship between amyloid reduction and clinical outcome. It’s just that when you don’t get the amyloid reduction that you expect you won’t get the clinical outcome that you expect,” he said. Reuters.
The global Alzheimer’s association said that the reading, although disappointing, further illustrates the link between removing beta-amyloid and slowing 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,” he said in a statement.
DIFFICULT TO DIAGNOSE
Most of the 55 million people suffering from dementia worldwide are likely to be affected by Alzheimer’s disease, according to the World Health Organization. In 2030, dementia is expected to affect 78 million.
Alzheimer’s disease is difficult to diagnose, especially in its early stages.
German’s Morphosys (MORG.DE) will receive a tiered royalty of about 2% to 3% on future gantenerumab sales from its early role in developing the drug. His stock plunged 31%.
Royalty Pharma (RPRX.O) will have the right to about 3% to 4% of gantenerumab sales under the 2021 deal with Morphosys.
Data from a late-stage trial of Eli Lilly’s amyloid-targeting antibody drug, donanemab, is expected in 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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