Fri, Dec 02, 2022 page11

• Roche shutters most clinical trials of Alzheimer’s drug after failed studies

  • Reuters, CHICAGO
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  Swiss drugmaker Roche Holding AG is closing down most clinical trials of its experimental Alzheimer’s drug gantenerumab after it failed to slow advance of the mind-robbing disease in a pair of large, late-stage studies, the company said on Wednesday.

  Roche presented full results of twin trials at an Alzheimer’s meeting in San Francisco after announcing last month that the drug had failed in the two trials.

  Unlike Eisai Co and Biogen Inc’s lecanemab, which appears to be on track for US regulatory approval after presenting successful trial results on Tuesday, Roche’s drug did not show a statistically significant benefit in patients with mild cognitive impairment and early Alzheimer’s disease.

  Both drugs are designed to remove forms of the protein beta amyloid from the brain, sticky plaques believed to play a major role in the disease.

  While Eisai’s infusion succeeded in slowing the advance of Alzheimer’s by 27 percent after 18 months, Roche’s drug reduced decline by just 8 percent in the Graduate I study and 6 percent in the Graduate II study compared with a placebo after two years.

  A key difference might have been in the drug’s ability to clear amyloid from the brain.

  In a presentation on Wednesday, researchers said gantenerumab, which is given by injection, only achieved amyloid clearance in 28 percent of patients in the Graduate I trial and 25 percent in Graduate II after two years, half of what the company expected to see.

  Lecanemab, by contrast, cleared amyloid in 68 percent of those in the study after 18 months.

  Howard Fillit, chief science officer at the Alzheimer’s Drug Discovery Foundation, said there are a number of reasons why Roche’s drug might have failed, including differences in chemistry, dosing and the way it was administered via injection versus infusion.

  However, the fact that the drug failed to remove amyloid deposits in the brain as expected clearly played a role, he added.

  The field of Alzheimer’s research is littered with failure and disappointment, including for several drugs in the same class, and previous efforts to prove gantenerumab’s worth.

  In 2014, the drug failed to show a benefit when given at a lower dose among patients with mild Alzheimer’s, and it failed again in 2020 in a Washington University School of Medicine trial of patients with an inherited form of Alzheimer’s.

  “Obviously, within the class, some drugs are working and some aren’t,” Fillet said.

  A Roche spokesman said in an e-mailed statement that the company would stop all gantenerumab studies in early Alzheimer’s disease, including extension studies of the Graduate trials and the Skyline Phase III study in patients with evidence of amyloid in the brain but no signs of cognitive decline.

  “In the Graduate studies, the level of amyloid removal was lower than expected. We expect the same, lower effect in the Skyline population, and consider this insufficient to continue,” the spokesman said.

  Meanwhile, Eisai plans to seek full approval of lecanemab in the US, Europe and Japan, potentially getting the treatment to people next year. It remains unclear how widely the drug would be used due to uncertainty over insurance coverage, including the US government’s Medicare plan for people age 65 or over, potential side effects and cost.

  One Wall Street analyst said he is not counting on measurable sales until 2024. Several estimated lecanemab might be priced at about US$20,000 per year.
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