Roche Discontinues The Majority of Alzheimer's Drug Trials Due to Failure

The bulk of clinical trials of Roche's experimental Alzheimer's drug gantenerumab have been terminated, the company reported on Wednesday, after it failed to reduce the disease's progression in two large, late-stage testing.

Roche released the complete results of its twin studies at a symposium on Alzheimer's in San Francisco, after announcing in November that the drug had failed in both trials.

Roche's drug did not demonstrate a statistically significant benefit in patients with mild cognitive impairment and early Alzheimer's disease, in contrast to Eisai Co (OTC:ESALY) Ltd and Biogen Inc (NASDAQ:BIIBlecanemab,drug, )'s which is on track for U.S. regulatory approval after presenting positive trial results on Tuesday.

Both drugs are designed to eradicate beta amyloid types from the brain, which are believed to play a major part in the disease.

Compared to a placebo, Eisai's infusion delayed the advancement of Alzheimer's by 27% after 18 months, but Roche's drug showed just an 8% drop in the Graduate I study and a 6% decline in the Graduate II study after two years.

The drug's ability to eliminate amyloid from the brain may have been a distinctive feature.

Researchers noted in a presentation on Wednesday that gantenerumab, which is provided through injection, eliminated amyloid in just 28% of patients in the Graduate I trial and 25% of patients in the Graduate II study, which was half of what the firm had predicted.

Lecanemab eradicated amyloid in 68% of study subjects after 18 months.

Dr. Howard Fillit, chief science officer at the Alzheimer's Medicine Discovery (NASDAQ:WBD) Foundation, indicated that modifications in chemistry, dose, and administration by injection as opposed to infusion may have contributed to the failure of Roche's medicine.

The fact that the medication did not eradicate amyloid deposits in the brain as predicted had a substantial impact, he stated.

The field of Alzheimer's research is plagued by failure and disappointment, most notably for other drugs in the same class and previous attempts to demonstrate gantenerumab's effectiveness.

The drug failed to demonstrate a benefit when delivered at a decreased dose to individuals with moderate Alzheimer's in 2014, and it failed again in 2020 in a trial done by the Washington University School of Medicine on patients with an inherited type of Alzheimer's.

Clearly, certain drugs within the class are effective while others are ineffective, Fillet said.

According to an email statement from a company spokesman, Roche will cease all gantenerumab studies in early Alzheimer's disease, including extension studies of the Graduate trials and the Skyline Phase III investigation in patients with evidence of amyloid in the brain but no signs of cognitive decline.

"The amyloid clearance rate was lower than anticipated in graduate studies. We foresee a comparable, if less, effect on the Skyline population and think this insufficient for continuing "The representative stated.

In an effort to deliver more of the treatment to the brain, Roche continues to investigate trontinemab, an alternative formulation of gantenerumab designed to transport the medication across the blood brain barrier - protective blood vessels that prevent substances in the bloodstream from entering the brain.

Rachelle Doody, the global head of neurological drug development at Roche, said in a statement, "We remain committed to Alzheimer's disease and will move our focus to new and maybe improved ways for developing new treatments."