Due to Failure, Roche Discontinues Most Alzheimer's Drug Trials

The majority of clinical trials of Roche's experimental Alzheimer's medicine gantenerumab are being halted, the firm announced on Wednesday, after it failed to slow the progression of the illness in two large, late-stage tests.

Roche disclosed the complete data of twin trials at an Alzheimer's conference in San Francisco, after reporting in November that the medicine 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, unlike Eisai Co (OTC:ESALY) Ltd and Biogen Inc (NASDAQ:BIIBlecanemab, )'s which appears to be on track for U.S. regulatory approval after presenting successful trial results on Tuesday.

Both medications are aimed to eliminate types of the protein beta amyloid, which are believed to play a crucial role in the disease, from the brain.

Compared to a placebo, Eisai's infusion slowed the progression of Alzheimer's by 27% after 18 months, but Roche's medication declined by just 8% in the Graduate I study and 6% in the Graduate II study after two years.

A major distinction may have been the drug's capacity to remove amyloid from the brain.

Researchers stated in a presentation on Wednesday that gantenerumab, which is administered through injection, only cleared amyloid in 28% of patients in the Graduate I trial and 25% of patients in the Graduate II study after two years, which was half of what the company anticipated.

After 18 months, lecanemab eliminated amyloid in 68% of study participants.

Dr. Howard Fillit, chief science officer at the Alzheimer's Medicine Discovery (NASDAQ:WBD) Foundation, stated that Roche's drug may have failed due to changes in chemistry, dosage, and administration by injection as opposed to infusion.

He noted that the fact that the medicine failed to eliminate amyloid deposits in the brain as anticipated played a significant influence.

The field of Alzheimer's research is plagued with failure and disappointment, notably for other medications in the same class and past attempts to demonstrate the value of gantenerumab.

In 2014, the medicine failed to demonstrate a benefit when administered at a reduced dose to patients with mild Alzheimer's, and it failed again in 2020 in a trial of patients with an inherited form of Alzheimer's conducted by the Washington University School of Medicine.

Clearly, some medications within the class are effective while others are not, Fillet stated.

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 loss, according to an email statement from a company spokesman.

"In graduate studies, the amyloid clearance rate was lower than anticipated. We anticipate the similar, if less, effect in the Skyline population and deem this insufficient for continuation "The spokesperson stated.

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

Roche's global head of neurodegenerative drug development, Rachelle Doody, stated in a statement, "We remain committed to Alzheimer's disease and will shift our attention to new and perhaps improved approaches for new medicines."