2022-11-15| Trials & Approvals

Roche’s Gantenerumab Fails Trials In Alzheimer’s Disease

by Joy Lin
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Roche’s candidate for Alzheimer’s disease, gantenerumab, failed to slow disease progression in people in the early stages of the disease, leaving rivals Biogen and Eisai as the leaders in the field.

News of the flop caused shares in Roche to drop 3.4%, their lowest point in almost seven weeks. Meanwhile, shares in their development partner Morphosys were down 29%. 

“So many of our families have been directly affected by Alzheimer’s, so this news is very disappointing to deliver,” said Levi Garraway, MD, Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.

“We are profoundly grateful to the study participants, their care partners, and study sites for their contributions to this research. While the Graduate results are not what we hoped, we are proud to have delivered a high-quality, clear and comprehensive Alzheimer’s dataset to the field, and we look forward to sharing our learnings with the community as we continue to search for new treatments for this complex disease.”

Related Article: Roche Bags Fast Track Label for New Alzheimer’s Diagnostic

Failing Primary Endpoints 

In a statement, the Swiss company said that while the Graduate 1 and 2 studies on gantenerumab showed some benefit in slowing clinical decline, the results were not statistically significant. 

The level of beta-amyloid, a protein that accumulates and forms plaques in the brains of Alzheimer’s patients, was lower than expected, Roche said. The company will present more detailed data at the Clinical Trials on Alzheimer’s Disease conference in San Francisco on November 30. 

Roche’s setback leaves rivals Biogen and Eisai at the forefront of the race to develop an Alzheimer’s treatment. In September, Biogen and Eisai reported a trial success with lecanemab, which met the primary endpoint and all secondary endpoints. 

Topline results from the Phase 3 Clarity AD clinical trial revealed that lecanamab reduced cognitive and functional decline by 27% at 18 months versus placebo. 

Lecanemab targets the earlier stages of amyloid buildup, compared to Roche’s drug which targets larger amyloid structures. The news of Roche’s failure has bolstered confidence in lecanemab, sending shares in Biogen up 3.8%. 

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