Roche has added another failure this year with its drug gantenerumab. As noted in Fierce Biotech, the drug was unable to improve functional or cognitive decline in two Phase III clinical trials that were part of the graduate program.
Roche is now developing an updated version of gantenerumab using “brain shuttle technology” that moves the drug across the blood-brain barrier, thus increasing concentrations of the drug’s active ingredient in the brain.
The gantenerumab failure came after another unsuccessful study of pre-symptomatic Alzheimer’s patients.
Analysts, companies, and advocacy groups are on the defensive. They find themselves again defending the theory as well as their research into this debilitating neurological disorder.
There is, however, one exception, and that is Biogen and Eisai’s lecanemab. The drug scored a win when it was front and center in a Phase III study in September. Lecanemab demonstrated that it could slow cognitive decline by as much as 27% against placebo.
Investigating The 2006 Theory
Alzheimer’s disease is now considered a global health concern. It is estimated that Alzheimer’s disease in the U.S. alone will double by 2050, yet it is still unclear to scientists how the disease causes symptoms.
The theory, presented in a 2006 paper published in Nature, used a mouse model demonstrating beta-amyloid clumps existing in the brain caused by a protein subtype. These
clumps were said to impair an individual’s memory and cause Alzheimer’s disease.
The highly influential paper has been accessed over 50,000 times and cited in over 2,200 scientific papers. The 2006 paper is now under investigation by Nature’s editorial team.
Regardless of the outcome of the investigation, the 2006 paper has had a significant impact on future research.
The Pipeline
At the moment, three prominent monoclonal antibodies target the reduction of amyloid plaques in the brain: Genentech’s gantenerumab, Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab. The three drugs are in the late stage of development with critical data to be presented next year.
In addition, according to a new study sponsored by the Alzheimer’s Association, 143 drugs are currently in development involving 172 clinical trials. If all the trials listed in the report were fully enrolled, the total number of participants would be 50,575 individuals.
The studies are evidence that the effort to find the solution to Alzheimer’s disease now has even more support than ever.
