Biogen Inc. and partner Eisai Co. Ltd. said the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing bid for lecanemab in early Alzheimer’s disease (AD) and mild AD. The humanized anti-soluble aggregated amyloid-beta monoclonal antibody is approved in the U.S., Japan, China, South Korea, Hong Kong and Israel, and is being sold in the U.S., where it’s branded Leqembi, as well as Japan and China. Eisai, of Tokyo, will ask the CHMP to re-examine the matter.
Muscle fatigue associated with brain inflammation could be prevented by modulating certain cytokines. Researchers at Washington University in St. Louis (WUSTL) have studied inflammation in the CNS in infection models of Escherichia coli, SARS-CoV-2 and amyloid-β toxicity, unveiling its impact on motor function, the role of IL-6 in this process and how to mitigate it in chronic disease.
About four months after varoglutamstat failed in Alzheimer’s disease, Vivoryon Therapeutics NV disclosed data from the Viviad phase IIb study with the same compound in kidney disease that provided cause for hope – and Anne Doering, chief financial officer, said the new data “reinforce our strategic shift.”
Asceneuron SA has raised $100 million in an oversubscribed series C to take its lead small molecule, ASN-51, into phase II, with aim of demonstrating it prevents the formation of tau tangles and slows the progression of Alzheimer’s disease.
The big advantage of cell culture to model diseases is its throughput. “You can play the disease over and over again in the dish,” Clive Svendsen told the audience at the International Society of Stem Cell Research (ISSCR) Annual Meeting held in Hamburg last week. That high throughput, however, is not particularly useful if the cell lines themselves do not accurately model the disease. Cancer cell lines are used in many cell culture experiments far beyond cancer for their ability to grow. But they are “highly abnormal,” Bill Skarnes told the audience at an innovation showcase, as well as quite unstable. “I don’t think the [HEK-293] cell line is the same in your lab as it is in the lab next door,” Skarnes said.
Zhejiang University of Technology has reported preclinical safety data for the novel multitargeting compound XYY-CP1106, being developed for the treatment of Alzheimer’s disease (AD). XYY-CP1106 is a multitargeted anti-AD compound that has previously demonstrated strong monoamine oxidase B (MAO-B) inhibition (IC50=14.7 nM), high Fe3+ chelation (pFe3+=18.04), no in vitro cytotoxicity and protection against cellular oxidative damage.
Beijing DP Technology Co. Ltd. has nominated DPT-0415, a novel small molecule targeting lipoprotein‐associated phospholipase A2 (Lp-PLA2), as a preclinical candidate for the treatment of diabetic retinopathy (DR) and diabetic macular edema (DME).
Researchers from the University of Texas Medical Branch have developed a novel tau immunotherapy delivered via intranasal route, able to enter the brain, and recognize and successfully clear tau aggregates in mouse models of tauopathy. Aberrant tau aggregates cause neurodegenerative symptoms in Alzheimer’s disease (AD), progressive supranuclear palsy (PSP) and dementia with Lewy bodies (DLB). Although these conditions present phenotypic differences, the fact of sharing tau deposits as a major hallmark tags them as tauopathies.
Beijing DP Technology Co. Ltd. has nominated DPT-0415, a novel small molecule targeting lipoprotein‐associated phospholipase A2 (Lp-PLA2), as a preclinical candidate for the treatment of diabetic retinopathy (DR) and diabetic macular edema (DME).
Less than a month after the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee handed down a unanimous vote in favor of Eli Lilly and Co.’s Alzheimer’s disease candidate (AD), donanemab, the agency approved the drug as a once-monthly injection for adults with early symptomatic disease. Branded Kisunla, the beta-amyloid antagonist marks the second approved AD drug that has demonstrated in clinical trials an ability to slow cognitive decline, going up against Leqembi (lecanemab) from Biogen Inc. and Eisai Co. Ltd., which won full approval in July 2023, only six months after nabbing an accelerated nod.
