Roche’s experimental Alzheimer’s drug does not meet primary endpoint in clinical trials

pharmafile | February 10, 2020 | News story | Sales and Marketing Alzheimer's, Roche, roche Alzheimer 

Roche has said its experimental drug, gantenerumab, did not meet its primary endpoint in people who have an inherited form of Alzheimer’s disease.

The results came from Roche’s Phase II/III DIAN-TU-001 clinical trial, which was funded by Washington University School of Medicine in St Louis. It also tested Eli Lilly’s solanzumab to see if either drug slowed the cognitive decline rate and improve disease biomarkers.

This trial involved 194 participants for up to seven years and the gantenerumab treatment involved 52 patients. Compared with placebo, Roche’s drug did not lead to a significant slowing of cognitive decline rate and failed to meet its primary end goal.

Levi Garraway, Roche’s Chief Medical Officer and global product development head, commented on the trials and said: “Although DIAN-TU didn’t reach its primary endpoint, the trial represents the first of its kind and a bold undertaking by all partners involved.

“Given its experimental nature, we are unable to draw firm conclusions about the impact of gantenerumab in autosomal-dominant Alzheimer’s disease. This outcome does not reduce our confidence in the ongoing Phase III GRADUATE clinical programme.”

The treatment is still being studied in two large Phase 3 studies in the broader population of people suffering from Alzheimer’s.

Conor Kavanagh

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