Roche has announced that its experimental drug, gantenerumab, did not meet its primary endpoint in people who have an early-onset, inherited form of Alzheimer’s disease.
The pharma giant said that the treatment did not show a significant slowing of the rate of cognitive decline in people treated, and that it will conduct additional analyses to understand the totality of the gantenerumab data from the study.
The medicine still continues to be studied in two large global Phase III studies (GRADUATE 1 and 2) in the broader population of people with Alzheimer’s not directly caused by gene mutations.
“We are very grateful to all those involved in this study and hope the data can further contribute to the science and collective understanding of this complex disease,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development. “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.”
Last year, Biogen and Eisai also stopped two global Phase III trials of the Alzheimer's drug aducanumab, after interim analyses indicated that the agent was ineffective and would not meet the primary endpoint.
Novartis, Amgen and Banner Alzheimer's Institute also recently decided to discontinue investigation of the BACE1 inhibitor CNP520 (umibecestat), citing that potential benefit for participants in the studies did not outweigh the risk.
Alzheimer's is a complex disease and one of the largest challenges facing healthcare today, with lots of failed treatments in past pipelines.
With few treatments available, and none that can tackle the course of the underlying disease, Alzheimer’s and other dementias are now the country’s leading cause of death.