The Zhitong Finance App learned that the initial treatment results of an experimental Alzheimer's drug developed by Japanese pharmaceutical giant Eisai (Eisai) that can be used in patients' homes are very optimistic. Early research results showed that the effects of this new version of the drug, that is, the subcutaneous injection version of the drug, surpassed the effects of its approved Alzheimer's drug, the infusion preparation Leqembi. This study may pave the way for more efficient absorption of this drug by the body.

According to a study published by the company at a conference in Boston on Wednesday, after six months of treatment, injectable drugs are 14% more able to remove amyloid (a toxic protein associated with Alzheimer's disease) than mainstream injectable drugs currently on the market. The subcutaneous injection version of Leqembi's drug had a blood concentration of 11% higher than the other versions.

However, the new version of the drug did not reduce the incidence of brain swelling and bleeding, which is Leqembi's most worrying side effect. Tokyo-based Eisai said the two versions had very similar rates of side effects — brain swelling and bleeding —.

According to data, Leqembi is the first drug that is clearly shown to slow the course of Alzheimer's disease. It must be administered intravenously every two weeks at a hospital or treatment center, so this usage scenario may be an obstacle for Alzheimer's patients to use this drug because they may need caregivers to take them to an appointment. Bloomberg Intelligence analysts said they expect the drug to be promoted slowly. The drug was fully approved in the US in July of this year.

Eisai and its key partner BIIB.US (BIIB.US) expect a subcutaneous version of the drug to be approved quickly. This method will allow patients or caregivers to inject Leqembi at home, eliminating the need to visit hospitals or treatment centers every two weeks.

Eisai and Baijian want to seize market share before Eli Lilly's (LLY.US.) competitive products are approved. Currently, the drug donanemab developed by Lilly to treat Alzheimer's disease is undergoing regulatory review and is only injected once a month. Research results show that the drug removes amyloid rapidly, and some patients can stop using the medication after about a year.

However, the Leqembi injection developed by Eisai may be able to be injected at home twice a week. The company's ongoing study compared 72 patients who received the new formula to 322 patients who received Leqembi injections. The study did not compare the final cognitive effects of the two versions.

A spokesperson said that if the test results remain unchanged for 12 months, Eisai hopes to apply to the US regulatory authorities for approval of the injectable preparation by the end of March 2024. At the Alzheimer's disease clinical trial conference in Boston, some doctors expressed cautious optimism about the new version of Leqembi.

At the conference, researchers also presented data from some of the patients in an early large-scale data set where Eisai's drugs were approved in July. The analysis focused on a lighter group of patients who had low levels of tau, another protein associated with Alzheimer's disease, in their brains. In this group, about 60% of patients treated with Leqembi improved their condition after 18 months of medication, while only 28% of patients with low tau protein treated with placebo improved their condition.

Although this discovery is in its early stages, the attending physicians were thrilled because it suggested that if drugs such as Leqembi were given early in the course of the disease, it might be possible to stop the disease. Eisai is already conducting a large-scale trial aimed at proving whether Leqembi can prevent Alzheimer's disease.

Some doctors also seem to be excited about the future of Leqembi injectable formulations. Paul Newhouse, director of the Center for Cognitive Medicine at Vanderbilt University Medical Center (Vanderbilt University Medical Center), said in an interview before Eisai's speech: “If it works, it will be a big deal.” “If a patient is not at home, the injection can be given at the local doctor's office without the patient having to travel long distances to the infusion center.

“This is a huge benefit for Alzheimer's patients,” said Newhouse, who has been using Leqembi in research for years because it may reduce capital consumption and logistical impact. He said Vanderbilt University is still developing a clinical infusion plan for this drug.

Even with a new, convenient, injectable version, the entire treatment process associated with Leqembi is still not easy. “Patients must undergo a specialized PET brain scan to test for amyloid protein to determine if they are eligible to take this medication. They must also perform MRI scans during treatment to monitor side effects.” Newhouse display.