News & numbers “The silver lining of Covid is that it has focused people’s attention on access. The tragedy is
that a lot of people died to get that focus.” Charles Gore, executive director of the Medicines Patent Pool (MPP) speaking in The Guardian
The promise of lecanemab
In a phase 3 clinical trial, lecanemab slowed the rate of cognitive decline in people with Alzheimer’s disease by 27%. The drug, a monoclonal antibody (mAb) developed by Biogen and Eisai, was designed to clear clumps of protein from the brain that many think are a root cause of Alzheimer’s disease. This theory is known as the amyloid hypothesis, and dictates that the protein amyloid- accumulates into toxic deposits as the disease progresses, causing the symptoms of dementia.
Haruo Naito, chief executive officer at Eisai, said: “The lecanemab Clarity AD study results prove the amyloid hypothesis, in which the abnormal accumulation of A in the brain is one of the main causes of Alzheimer’s disease, when targeted with a protofibril-binding therapy. Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimer’s disease as well as further activate innovation for new treatment options.”
Despite the significance of the results, experts are reluctant to accept that they validate the amyloid hypothesis, at least until the study is released in a peer- reviewed journal and the methodology can be fully scrutinised. Speaking in Nature, Brent Forester, director of the Geriatric Psychiatry Research Program at McLean
Hospital in Belmont, Massachusetts, who helped to run the clinical trial for lecanemab, said: “I don’t think one study will prove a very long-standing controversial hypothesis. But one positive study supports the hypothesis.” Other experts have been more critical, arguing that the slowing of cognitive decline was so small that they would question whether it is more significant than that of aducanumab – the controversial amyloid-reducing drug from Biogen that flopped commercially after gaining accelerated approval from the FDA in June 2021. “I don’t think we’re seeing a clinical benefit that’s that different from aducanumab,” Dr Constantine Lyketsos from Johns Hopkins School of Medicine, told CNN. “I think we’re seeing a successful strategic approach by the companies developing it to have a very large study that was big enough to detect a small effect,” he added.
The Clarity AD study included 1,800 people, who were given an infusion of lecanemab or a placebo on a 1:1 ratio. The results showed a treatment difference of -0.45 (27%) on the Clinical Dementia Rating – Sum of Boxes. Biogen and Eisai are currently awaiting a decision – which many expect will come in January 2023 – from the FDA after requesting the same accelerated pathway used for aducanumab.
Treating tuberculosis
Researchers in Japan have identified a way to treat Mycobacterium tuberculosis (M. tuberculosis) without the risk of making other bacteria multi-drug resistant. M. tuberculosis is most commonly treated with a cocktail of four drugs that must be taken for up to six months, but this can lead to antibiotic resistance, both because people may not finish the full course, or because one of the drugs can act on other bacteria. An antimicrobial compound discovered at Shinshu University, which the researchers named evybactin, could
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selectively act against M. tuberculosis, avoiding the risk against other bacteria. “Microorganisms such as actinomycetes and filamentous fungi have long been used as a source of antibiotics,” said Yu Imai, assistant professor at the Institute for Biomedical Sciences at Shinshu University. “However, in recent years, it has become difficult to find new antibiotics from these microorganisms, as known substances have been re-isolated. Recently, we have succeeded in discovering several antibiotics from the nematode symbiotic bacterium
Photorhabdus and have shown that this bacterium is a useful source for the discovery of new antibiotics.” The researchers found that evybactin was transported inside the target bacteria across the cell membrane by BacA, a carrier of hydrophobic compounds, and then it binds to a specific site of DNA gyrase. This finding is significant as the method used could potentially discover even more antibiotics. The researcher’s findings were published in the journal Nature Chemical Biologyon August 2022.
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net Diabetes
GRADE study In a large clinical trial that directly
compared four drugs commonly used to treat type 2 diabetes, researchers from the University of Minnesota Medical School aided in the discovery that insulin glargine and liraglutide performed best. While there is general agreement among health care professionals that metformin combined with diet and exercise is the best early approach in diabetes care, there is no consensus on what to do next to best keep high blood glucose in check.
Elizabeth Seaquist, MD, department of medicine chair at the University of Minnesota Medical School and endocrinologist with M Health Fairview, said: “The GRADE study is the first to compare the efficacy of four drugs commonly used to treat type 2 diabetes when added to metformin in people with short-duration diabetes. It found that liraglutide was superior to glimepiride and sitagliptin in controlling blood sugars. This study provides evidence that clinicians can use in developing treatment plans with their patient.”
The study found that participants taking
metformin plus liraglutide or insulin glargine achieved and maintained their target blood levels for the longest time compared to sitagliptin or glimepiride. This translated into approximately six months more time with blood glucose levels in the target range compared with sitagliptin, which was the least effective in maintaining target levels. Treatment effects did not differ based on age, sex, race or ethnicity. However, none of the combinations overwhelmingly outperformed the others.
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