Second phase III study results for anti-tau Alzheimer’s treatment released

Results of a second phase III clinical trial of Leuco-Methylthioninium Bis(Hydromethanesulphonate) (LMTX) developed by TauRx Therapeutics as the first anti-tau treatment for people with mild Alzheimer’s disease have been announced. Results of the trial were published this week in the Journal of Alzheimer’s Disease.

LMTX is a second-generation drug aimed at blocking the build-up of tau protein in Alzheimer’s. The drug, given twice daily as a pill, is based on the structure of a chemical called methylene blue, used as a dye in research and to aid surgery.

Dr David Reynolds, Chief Scientific Officer at Alzheimer’s Research UK, said:

“This trial was designed to test a drug that targets the build-up of abnormal tau protein, a hallmark of Alzheimer’s disease and several other forms of dementia. Despite a lack of clarity around exactly how LMTX targets tau, there has been much hope about the benefits a drug against this process could bring for people living with dementia.

“A previous study tested LMTX in a group of people with mild to moderate Alzheimer’s, most of whom were taking existing, approved Alzheimer’s medications. While overall LMTX did not lead to the benefits researchers were hoping to see, the results pointed to potential improvements in a small number of people who took the drug by itself and not in combination with existing Alzheimer’s drugs.

“The results published this week also showed some potential benefits for LMTX as a monotherapy when compared against its effects alongside existing Alzheimer’s drugs, but we can’t draw any firm conclusions without more research. There are a number of reasons people with Alzheimer’s may not take currently approved medications and, while the researchers tried to take these into account, they may explain why the disease appeared to progress more slowly in people who took LMTX as a monotherapy.

“In order to get a clearer idea of the effects of LMTX, we now need to see carefully planned studies that focus on LMTX alone, and don’t involve people who are taking other Alzheimer’s medications.”