- Evidence shows small benefits, but with no statistical validity
- Roche’s setback leaves Biogen, Eisai leader in the field
- Onus on Roche CEO appointed to revive development fortunes
- Roche shares down 3.4%, development partner Morphosys down 29%
Nov 14 (Reuters) – Roche’s Alzheimer’s drug candidate (ROG.S) has not been shown to slow the progression of dementia in two drug trials, leaving rivals Biogen (BIIB.O) and Eisai (4523.T) as a leader in a high stakes race to launch a treatment for memory-stealing disease.
Roche said in a statement Monday that twin studies known as Graduate 1 and 2 have not met their main goal of showing that the drug gantenerumab could preserve abilities such as remembering, problem solving, orientation and personal care in patients suffering from early stages of cancer. ‘Alzheimer’s pathology.
The Swiss pharmaceutical company conducted two identically designed studies, each with around 1,000 participants, which were examined and questioned by doctors for more than two years. Within each study, volunteers were randomly assigned to receive the injectable antibody drug gantenerumab or a placebo.
The drug was associated with an 8% relative reduction in clinical decline in Graduate 1 and 6% in Graduate 2 compared to placebo, but those results were not statistically significant, the company said in a statement.
Credit Suisse analysts, who had seen a 20% chance that the drug would reach an annual sales peak of $ 10 billion, described the failure of the process as “unambiguous”.
Berenberg analysts had placed a 50% chance that gantenerumab would peak at $ 10 billion.
Roche shares fell 3.4% to a low in nearly seven weeks.
Shares of US drug companies Biogen Inc (BIIB.O) and Eli Lilly and Co (LLY.N), which are developing rival treatments for Alzheimer’s, were up 3.8% and 2.3% respectively in pre -market.
Analysts said reading the trial would impact the stock market’s confidence in Roche’s research capabilities, especially after the hopeful tiragolumab in lung cancer immunotherapy failed in trials earlier this year, beating the shares of the company.
“The development pipeline has disappointed a little too often to keep the stock on the list of favorites,” analysts at Luzerner Kantonalbank said in a research note.
Gantenerumab was designed to bind to aggregated forms of beta amyloid and remove brain amyloid plaques, which are thought to play a crucial role in slowly progressing dementia disease.
The setback will be another challenge for Roche’s chief diagnostics CEO Thomas Schinecker, who will be promoted in March. He will replace Severin Schwan, the CEO who has led a successful campaign to diversify Roche’s traditional focus on cancer.
The quest to develop an Alzheimer’s drug targeting beta amyloid or other molecules has been plagued with a long list of study failures.
But in September Biogen had a surprise hit with an experimental Alzheimer’s drug it developed with Eisai, rebuilding trust among industry executives and researchers in the beta-amyloid approach.
Biogen and Eisai said at the time their drug candidate lecanemab slowed the progression of brain wasting disease by 27% compared to a placebo in a large study of patients in the early stages of Alzheimer’s.
The failure of Roche’s trial “eliminates the greatest competitive risk for lecanemab,” Baird analyst Brian Skorney said in a statement.
The Swiss firm’s compound aimed primarily at larger amyloid structures, while Biogen’s lecanemab aimed at the early stages of amyloid accumulation, among other differences in molecules and test designs.
Roche released only the main outcome of the trials on Monday. He plans to present detailed data at the Clinical Trials on Alzheimer’s Disease conference in San Francisco on November 30.
Rachelle Doody, head of neurodegeneration at Roche, said she was very disappointed, adding that the test measures for the removal of amyloid were also lower than hoped.
“We will show that there is a relationship between amyloid lowering and clinical outcomes. It’s just that when you don’t get the amyloid lowering you expected, you won’t get the clinical outcome you expected,” Reuters said.
The global Alzheimer’s Association said the reading, while disappointing, further illustrated the relationship between beta-amyloid removal 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,” said a statement.
DIFFICULT TO DIAGNOSIS
According to the World Health Organization, most of the 55 million people with dementia in the world are likely to be affected by Alzheimer’s disease. Dementia is expected to hit 78 million in 2030.
Alzheimer’s is difficult to diagnose, especially during its early stages.
Germany’s Morphosys (MORG.DE) would receive tiered royalties of around 2% to 3% on future sales of gantenerumab from its initial role in the drug’s development. Its shares plummeted 31%.
Royalty Pharma (RPRX.O) would have been entitled to approximately 3-4% of gantenerumab sales under a 2021 agreement with Morphosys.
Data from a key late-stage study of Eli Lilly’s amyloid-targeted antibody drug, donanemab, is expected by mid-2023.
Ludwig Burger in Frankfurt; Additional reports 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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