TauRx Pharmaceuticals has reported data from a prespecified analysis of the Phase III LUCIDITY trial of oral hydromethylthionine mesylate (HMTM) in patients with Alzheimer’s disease (AD).
HMTM has been designed to reduce tau pathology in AD.
LUCIDITY comprised a double-blind controlled trial for 12 months designed to investigate changes in various clinical and biomarker outcomes, followed by a 12-month period.
The trial compared HMTM 16mg/day against methylthioninium chloride (MTC) 4mg administered twice weekly over the first 12 months.
Neurofilament light chain (NfL) was the principal blood biomarker endpoint in the study.
The trial also evaluated the impact of the anti-tau product HMTM on NfL.
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NfL is an established biomarker for brain neurodegeneration.
At a dose of HMTM 16mg/day, a statistically significant 93% reduction of NfL in blood levels of participants treated over 12 months against the control group was observed. This reduction was correlated significantly with a tau biomarker (p-tau 181) in blood.
TauRx Pharmaceuticals executive chairman Claude Wischik said: “The NfL results demonstrate that a drug targeting tau pathology reduces the neurodegeneration that underlies the clinical decline in AD.
“They bring us a step closer to offering an effective new treatment option for people with AD.
“Because it is taken as a tablet and has a strong safety profile, HMTM would be readily accessible to people needing a disease-modifying treatment.”
TauRx is planning to seek regulatory approval in the US, the UK and other territories based on the submission of results from LUCIDITY and earlier trials.
It is also preparing to report both the NfL and the full 24-month data.
HMTM is claimed to have a key advantage over other disease-modifying therapies (DMTs), as it does not cause amyloid-related imaging abnormalities (ARIAs).