New Alzheimer’s Drug Slows Cognitive Decline by 27%

Calendar September 28, 2022 | Posted by admin

A new Alzheimer’s drug from Japanese pharmaceutical company Eisai and US drugmaker Biogen has shown promising results in a large-scale clinical trial. The companies announced the trial’s success in a press release, saying their drug — called lecanemab — was observed to have slowed cognitive decline in Alzheimer’s patients by 27% over 18 months.

The companies said 1,795 patients with early-stage Alzheimer’s were randomly selected to receive a placebo treatment or doses of lecanemab every two weeks. Their cognitive decline was then measured on six fronts, including “memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.” According to the statement, lecanemab significantly “reduced clinical decline” over the 18-month timeframe.

Lecanemab, per Eisai, is a monoclonal antibody treatment, which targets toxic amyloid plaques — protein clumps that researchers proposed were the cause of the neurodegeneration seen in Alzheimer’s.

The companies noted that around 21% of the patients who received the lecanemab treatment experienced brain swelling that was visible on PET scans.

“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” said Michel Vounatsos, Biogen‘s chief executive officer in the companies’ joint press release.

Eisai’s chief executive Haruo Naito said in the company’s press release that the lecanemab study’s success was “an important milestone for Eisai in fulfilling our mission to meet the expectations of the Alzheimer’s disease community.”

Source: https://investors.biogen.com/
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The Drugmaker Merck Says Its Antiviral Pill Is Effective Against Coronavirus

Calendar October 1, 2021 | Posted by admin

The drug maker says its pill was shown in a clinical trial to cut the risk of hospitalization or death from the virus in half. Australia is accelerating plans to ease international travel restrictions for its citizens and permanent residents.

The drug maker Merck said on Friday that it would seek authorization for the first antiviral pill for Covid after its drug, known as molnupiravir, was shown in a clinical trial to cut the risk of hospitalization or death in half when given to high-risk people early in their infections.

The treatment could become the first in a wave of antiviral pill products, which experts say could offer a powerful new tool in efforts to tame the pandemic, as they could reach more people than the antibody treatments that are being widely used in the United States for similar patients.

“I think it will translate into many thousands of lives being saved worldwide, where there’s less access to monoclonal antibodies, and in this country, too,” said Dr. Robert Shafer, an infectious disease specialist and expert on antiviral therapy at Stanford University.

Late-stage study results of two other antiviral pills, one developed by Pfizer and the other by Atea Pharmaceuticals and Roche, are expected within the next few months.

The Merck drug, which is designed to stop the coronavirus from replicating, is to be taken as four capsules twice a day for five days.

Merck said an independent board of experts monitoring its study data had recommended that its trial be stopped early because the drug’s benefit to patients had proved so convincing. The company said that the Food and Drug Administration had agreed with that decision.

For the research, the monitors looked at data through early August, when the study had enrolled 775 volunteers in the United States and overseas. For volunteers who received the drug, their risk of being hospitalized or dying fell 50 percent, without any concerning side effects, compared with those who received placebo pills, Merck said in a news release announcing the findings.

Seven percent of volunteers in the group that received the drug were hospitalized, and none of them died, compared with a 14 percent rate of hospitalization and death — including eight deaths — in the group that received the placebo.

The Merck pill’s efficacy was lower than that of monoclonal antibody treatments, which mimic antibodies that the immune system generates naturally when fighting the virus. Those drugs have been in high demand recently, but they are expensive, are typically given intravenously, and have proved cumbersome and labor-intensive for hospitals and clinics to administer. Studies have shown that they reduce hospitalizations and deaths 70 to 85 percent in similar high-risk Covid patients.

Source: https://www.nytimes.com/

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Two New Trials of Coronavirus Treatment

Calendar March 18, 2020 | Posted by admin

Drugs used for treating arthritis are being tested as treatments for COVID-19, the disease caused by a new coronavirus, as researchers rush to find ways of helping patients and slowing the number of infections. Sanofi and Regeneron Pharmaceuticals said on Monday they began a clinical trial of their rheumatoid arthritis drug Kevzara as a coronavirus treatment, while in Spain a separate trial is studying if a combination of two drugs can slow down the spread of coronavirus among people. Enrolments for the mid-to-late stage trial of Kevzara, an immune-system modifying drug known as a monoclonal antibody, will begin immediately and test up to 400 patients, Sanofi and Regeneron said in a joint statement. Regeneron in February announced a partnership with the U.S. Department of Health and Human Services to develop a treatment for the new coronavirus, called SARS-CoV2, and said it would focus on monoclonal antibodies.

The virus that emerged in central China in December has now infected more than 179,000 people worldwide, according to the Johns Hopkins University, which is tracking these figures. Doctors have seen that many of those who become critically ill from SARS-CoV2 are experiencing a so-called cytokine storm, which happens when the immune system overreacts and attacks the body’s organs. Some researchers think drugs that can suppress the immune system, including monoclonal antibodies, might be useful for limiting this autoimmune response.

Meanwhile, Barcelona-based researchers said on Monday they would administer a drug used to treat HIV – containing darunavir and cobicistat – to a coronavirus–infected person. The patient’s close contacts would be administered hydroxychloroquine, a drug for malaria and rheumatoid conditions because laboratory experiments suggest it prevents this strain of coronavirus from reproducing. “The goal of our study is to separate the transmission chains,” Oriol Mitja, researcher at Germans Trias i Pujol Research Institute, told a news briefing. Patients with coronavirus can infect between 5% and 15% of the people they come into contact with during the 14 days after starting to show symptoms, he said. The trial’s goal is to reduce that number below 14 days and also to reduce the percentage of contacts infected and researchers plan to analyze the results in 21 days. Around 200 patients with coronavirus and 3,000 of their close contacts will take part in the trial, which has private and public funding.

Source: https://www.reuters.com/

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