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Roche, a Swiss drugmaker, announced its Alzheimer’s drug did not meet the primary goal of slowing the disease during two clinical trials.
Phase III of Graduate I and II studies were two global, double-blind, and randomised ones. It was a placebo-controlled clinical trial to evaluate the safety and efficacy of the anti-amyloid monoclonal antibody gantenerumab.
The studies were conducted on 1,965 people over 27 months across 30 countries, according to a company statement. The study participants, with mild cognitive impairment and dementia due to Alzheimer’s, were given the injectable drug and a placebo.
The drug gantenerumab was associated with a relative reduction in the clinical decline of 8% in Graduate I and 6% in Graduate II, compared with the placebo.
“The studies did not meet their primary endpoint of slowing clinical decline,” the company stated.
No significance
In Graduate I and Graduate II trials, people treated with gantenerumab showed a slowing clinical decline. “However, neither was statistically significant.”
The level of beta-amyloid removal, the protein that builds up to make plaques in the brains of people with Alzheimer’s disease, was lower than expected.
“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,” said Levi Garraway, Roche’s chief medical officer.
A Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score is commonly used to determine a person’s stage of Alzheimer’s.
The CDR-SB measures cognitive and functional change across six areas: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Participants treated with gantenerumab showed a slowing, but an insignificant score of clinical decline in Graduate I and Graduate II from the baseline score of CDR-S.
Roche, founded in 1896 in Basel, Switzerland, will present the findings at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) conference on November 30.
The global Alzheimer’s therapeutics market was valued at $4.04 billion in 2021 and is expected to expand at a compound annual growth rate of 16.2% from 2022 to 2030., according to Grand View Research.
Rising prevalence
The rising prevalence of Alzheimer’s disease and the approval of disease-modifying therapies are expected to fuel market growth.
According to the NCBI, in 2021, about 6.2 million people aged 65 and above living in America were suffering from Alzheimer’s disease. It is estimated to increase to around 13.8 million by 2060.
Women are more prone to be diagnosed with Alzheimer’s than men due to their longer life expectancy.
Alzheimer’s disease is becoming the most common cause of death in neurodegenerative diseases and a physical disability that require immediate treatment.
