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TauRx Applies for UK Marketing Authorization for HMTM as Alzheimer’s Disease Treatment

NextEdge Admin

02 Jul 2024

2 min 17 sec

TauRx Pharmaceuticals Ltd, a prominent figure in tau-centric research for Alzheimer’s disease (AD), has announced the submission of a UK Marketing Authorisation Application (MAA) for hydromethylthionine mesylate (HMTM), aiming to address mild cognitive impairment (MCI-AD) and mild to moderate stages of Alzheimer’s dementia.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated HMTM under the Innovative Licensing and Access Pathway (ILAP). If approved, this could mark a pivotal moment as the first accessible, safe, oral treatment targeting tau pathology for Alzheimer’s patients in the UK.

The MAA builds upon comprehensive evidence, including data from the recently released 24-month Phase 3 LUCIDITY trial and earlier Phase 3 studies in mild to moderate AD. Consistent findings across these trials demonstrate HMTM’s efficacy in slowing cognitive decline, enhancing daily living activities, and reducing brain shrinkage.

Tau aggregation is closely linked to cognitive deterioration, brain atrophy, and neuronal damage characteristic of Alzheimer’s disease. HMTM inhibits tau-protein aggregation selectively within brain cells and enhances brain function through an additional mechanism.

Professor Claude Wischik, Executive Chairman of TauRx, emphasized the submission’s significance, stating, “This milestone underscores TauRx’s commitment to potentially offering a novel treatment and renewed hope to patients and families affected by this devastating disease.”

Pending regulatory approval, the introduction of HMTM could revolutionize Alzheimer’s treatment in the UK, addressing a critical unmet need with its innovative approach targeting tau pathology directly.