The application for HMTM to treat Alzheimer’s is based on data from Phase III LUCIDITY trial and two prior Phase III studies. Credit: CGN089 / Shutterstock.

TauRx Pharmaceuticals has filed a marketing authorisation application (MAA) with the UK Medicines and Healthcare products Regulatory Agency, seeking approval for hydromethylthionine mesylate (HMTM) to treat Alzheimer’s disease (AD).

HMTM is intended for treating mild cognitive impairment due to Alzheimer’s disease (MCI-AD) and mild to moderate dementia stages associated with AD.

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The UK regulator had previously designated the innovative licensing and access pathway for HMTM.

The UK could become the first country to offer this oral treatment on approving HMTM.

TauRx’s MAA for the asset is underpinned by comprehensive evidence from the 24-month Phase III LUCIDITY clinical trial and two previous Phase III studies.

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These trials consistently demonstrated HMTM’s benefits in slowing cognitive decline, maintaining daily living activities and reducing brain atrophy rates.

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Tau aggregation, a key factor in Alzheimer’s, correlates with cognitive decline severity and brain nerve cell damage. HMTM counters this by selectively inhibiting tau-protein aggregation.

Designed as an oral AD treatment, HMTM targets tau aggregation and enhances brain function through a secondary, tau-independent action that raises acetylcholine levels in the hippocampus.

The global Phase III LUCIDITY trial involving over 3,000 subjects has concluded and established the safety profile of HMTM.

A notable finding from the LUCIDITY trial was the significant reduction in neurofilament light chain, a biomarker for neurodegeneration, at the 12-month mark of the study.

Clinical assessments of cognition revealed sustained improvements from baseline over 18 months in MCI-diagnosed patients.

TauRx executive chairman professor Claude Wischik stated: “This is a significant milestone for TauRx and is an important step in potentially bringing a new type of treatment and a new hope to patients and families who carry the burden of this terrible disease.”