Drugmaker Roche’s experimental Alzheimer’s drug gantenerumab has been granted breakthrough therapy designation from the Food and Drug Administration, opening a path for fast-tracked federal approval.
Gantenerumab has been shown to significantly reduce brain amyloid plaque, a hallmark of Alzheimer’s. If approved, it could be the second plaque-busting drug on the market following aducanumab (Aduhelm). It also is the “first and only anti-amyloid antibody being investigated for subcutaneous administration” in late-stage trials to treat the disease, Roche announced Friday. It could potentially be given to patients at home, the company said.
The company expects that its ongoing Phase III GRADUATE trial will produce data to be presented for federal review in the second half of 2022. More than 2,000 study participants will receive the drug for more than two years, it said.
“This breakthrough therapy designation reinforces our confidence in gantenerumab, which would be the first subcutaneous medicine for the treatment of Alzheimer’s disease with the potential for at-home administration,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development.
In related news:
Alzheimer’s drug shown to reverse brain aging to be tested in humans After 15 years of development, an Alzheimer’s drug shown to reverse signs of brain aging and prevent memory loss in mice will kick off a phase 1 trial in humans with the help of a two-year, $4.5 million grant from the National Institute of Aging. The researchers have steered away from the amyloid beta-busting technology used in the newly approved Alzheimer’s drug aducanumab (Aduhelm). Instead, they have chemically altered a compound called fisetin, found in vegetables and fruits. The resulting drug, called CMS121, targets inflammation and lipid synthesis and will be tested in 56 healthy volunteers. Data from the trial is expected to be released by fall 2022.
