Roche’s Alzheimer’s drug fails final phase of clinical study

The pharmaceutical group Roche announced on Monday that a phase III study [la dernière étape dans le développement d’un médicament, ndlr] on gantenerumab, its drug-candidate against so-called early forms of Alzheimer’s disease, had not reached its primary endpoint.

Patients treated with gantenerumab showed a slowing of clinical decline of 6 to 8% compared to placebo, a result considered statistically insignificant and therefore not demonstrating the efficacy of the treatment. The level of elimination of beta-amyloid, a protein which accumulates in the form of plaques in the brain and is suspected to be the cause of the onset of Alzheimer’s disease, was lower than expected. The role of these amyloid deposits in causing the disease is debated.

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Last June, the Rhine multinational had encountered another clinical failure in the development of crenezumab, another candidate based on the same approach co-developed by its American subsidiary Genentech and the Vaud-based laboratory AC Immune.

Doubts expressed

“Although the results of the Graduate (study) were not what we had hoped for, we are proud to have delivered a high quality, clear and comprehensive dataset on Alzheimer’s disease to the field, and we are eager to share our knowledge with the community, ”said Levi Garraway, medical director of the Basel giant, quoted in a press release.

Roche is due to present key findings from the Graduate study program at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference to be held in San Francisco from November 29 to December 2.

Read also: Biogen and Eisai’s success bolsters Roche’s approach to treating Alzheimer’s

The financial community had repeatedly expressed serious doubts as to the chances of success of the Roche candidate, even if some hope had settled on the market, after the first positive results reported in September by the competing laboratories Biogen/ Eisai, with a similar approach aimed at preventing beta-amyloid buildup.

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