Eisai on Wednesday said an injectable version of the Alzheimer’s drug Leqembi showed promising initial results in a clinical trial, potentially paving the best way for a recent and more convenient option for administering the antibody treatment.
Nevertheless, the injection didn’t cause lower rates of brain swelling and bleeding, that are Leqembi’s most concerning unintended effects.
Leqembi, made by Eisai and its partner Biogen, is the primary medicine proven to slow the progression of Alzheimer’s in people on the early stages of the memory-robbing disease. U.S. regulators in July approved a version of Leqembi that is run twice monthly through the veins, which is a technique known as intravenous infusion.
But Eisai and its partner Biogen are hoping to win approval for a subcutaneous version of the drug, which can be an injection under the skin. That method would allow patients or caregivers to manage the Leqembi at home, freeing them from the necessity to travel to an infusion center such as a hospital every two weeks.
Eisai and Biogen said in a release that they plan to use for U.S. approval of subcutaneous Leqembi by the tip of March.
Eisai presented the preliminary results, from an extension to a late-stage trial that supported the approval of intravenous Leqembi, on the Clinical Trials on Alzheimer’s Disease conference in Boston. That study tested subcutaneous doses of Leqembi and measured the drug’s safety and effects on a protein called amyloid – also known as plaque – that builds up within the brain and is related to Alzheimer’s.
The study showed that a set of two injections administered once weekly produced similar results after six months to twice-monthly intravenous infusions when it comes to safety, the concentration of the drug within the blood and its ability to clear plaque buildups within the brain, Eisai said.
The study specifically showed that the injectable type of Leqembi removed 14% more plaque than the approved intravenous formulation. Blood concentration levels of the drug were 11% higher with subcutaneous Leqembi than the opposite version.
However the newer form still showed unintended effects known as amyloid-related imaging abnormalities, or ARIA. The removal of plaques from the brain may be related to brain swelling and bleeding – also known as ARIA-E and ARIA-H – which may be severe and even deadly in rare cases.
Almost 17% of patients who got weekly injections had ARIA-E, compared with 13% who got the drug via intravenous infusion. And 22% of those taking the shots had ARIA-H, versus 17% who received the opposite form.
Roughly 6.7 million Americans age 65 and older reside with Alzheimer’s, in line with the Alzheimer’s Association. That group is projected to rise to almost 13 million by 2050.
One in three seniors die with Alzheimer’s or one other type of dementia, which kills more people than breast cancer and prostate cancer combined, the association said. The neurodegenerative disease begins with mild memory loss but eventually impairs an individual’s ability to think and perform each day activities.
There may be a wealth of research on Alzheimer’s, but it surely has been notoriously difficult to treat. Multiple drugs designed to focus on the disease have failed in trials. The sheer cost and length of that research further impede drug development. And lately, scientists have ignited a debate over the true reason for the disease and what the drugs should goal.