Roche’s Alzheimer’s drug fails to meet goal in long awaited trial

Date:

  • Trials show a small benefit, but with no statistical validity
  • Roche’s setback leaves Biogen, Eisai leaders in the field
  • Onus on Roche CEO candidate to revive development fortunes
  • Roche shares down 3.4%, development partner Morphosys down 29%

Nov 14 (Reuters) – Roche’s (ROG.S) drug candidate for Alzheimer’s disease failed to be shown to slow the progression of dementia in two drug trials, leaving rivals Biogen (BIIB.O) and Eisai (4523. T) leaders remain in a high-stakes race to launch a treatment for the memory-robbing disease.

Roche said in a statement Monday that twin studies, known as Graduate 1 and 2, had failed to achieve their main goal of showing that the drug gantenerumab could preserve abilities such as recall, problem solving, orientation and personal care in patients suffering from early stages. of Alzheimer’s disease.

The Swiss drugmaker conducted two identically designed studies, each with about 1,000 participants, that were examined and surveyed by physicians for more than two years. Within 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 Graduate 1 and 6% in Graduate 2 compared to the placebo, but those results were not statistically significant, the company said in a statement.

Credit Suisse analysts, who had seen a 20% chance of the drug reaching peak annual sales of $10 billion, described the trial’s failure as “unequivocal.”

Berenberg analysts had assumed a 50% chance that gantenerumab would hit the $10 billion peak.

Roche shares fell 3.4% to their lowest level in nearly seven weeks.

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

Analysts have said the trial’s readout would erode stock market confidence in Roche’s research prowess, especially after lung cancer immunotherapy hopeful tiragolumab failed earlier this year in trials and mishandled the company’s stock.

“The development pipeline has disappointed a little too often to keep the stock on a favorite list,” analysts at the Luzerner Kantonalbank said in a research note.

Gantenerumab is designed to bind to aggregated forms of beta-amyloid and clear amyloid plaques in the brain, which are believed to play a critical role in slowly progressing dementia.

The setback will be an additional challenge for CEO candidate Thomas Schinecker, Roche’s chief of diagnostics, who will be promoted in March. He will replace Severin Schwan, the CEO who has led a successful campaign to diversify away from Roche’s traditional focus on cancer.

The quest to develop an Alzheimer’s drug targeting beta-amyloid or other molecules has been beset by a long list of failed studies.

But Biogen scored surprising trial success in September with an experimental drug for Alzheimer’s disease it was co-developing with Eisai, restoring the confidence of 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-debilitating disease by 27% compared to a placebo in a large study of patients in the early stages of Alzheimer’s disease.

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

The Swiss company’s formulation focused primarily on larger amyloid structures, while Biogen’s lecanemab targeted earlier stages of amyloid build-up, among other differences in the molecules and trial designs.

Roche only released the main outcome of the studies on Monday. It plans to present detailed data at the Clinical Trials on Alzheimer’s Disease conference in San Francisco on Nov. 30.

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

“We will show that there is a relationship between amyloid reduction and clinical outcomes. It’s just that if you don’t get the amyloid reduction you expected, you won’t get the clinical outcome you expected,” she said. Reuters.

The global Alzheimer’s Association said the readout, while disappointing, further illustrated the relationship between removing beta-amyloid and slowing clinical decline, but that 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,” it said in a statement.

DIFFICULT TO DIAGNOSE

According to the World Health Organization, most of the 55 million people who suffer from dementia worldwide will have Alzheimer’s disease. By 2030, dementia is expected to affect 78 million people.

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

Germany’s Morphosys (MORG.DE) is said to have received incremental royalties of around 2% to 3% on future sales of gantenerumab due to its early role in the drug’s development. Shares plummeted 31%.

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

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

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

Our Standards: The Thomson Reuters Trust Principles.

The Valley Voice
The Valley Voicehttp://thevalleyvoice.org
Christopher Brito is a social media producer and trending writer for The Valley Voice, with a focus on sports and stories related to race and culture.

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