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TauRx Pharmaceuticals Ltd, has announced the submission of a UK Marketing Authorisation Application (MAA) for hydromethylthionine mesylate (HMTM). This drug is intended for the treatment of mild cognitive impairment (MCI-AD) and mild to moderate stages of dementia caused by Alzheimer’s disease (AD).
“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,” stated Professor Claude Wischik, Executive Chairman of TauRx.
HMTM has received designation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the Innovative Licensing and Access Pathway (ILAP). Should the MAA be approved, the UK could become the first country to offer this accessible, safe, oral treatment targeting tau pathology, a hallmark of Alzheimer’s disease.
The MAA submission is supported by data from the 24-month Phase 3 LUCIDITY trial and two earlier Phase 3 trials, all of which have shown consistent benefits in slowing cognitive decline, improving daily functioning, and reducing brain atrophy rates. Tau protein aggregation is a key factor in the cognitive decline and neurodegeneration seen in Alzheimer’s disease, and HMTM works by inhibiting this process and enhancing brain function.
The LUCIDITY trial, which recently concluded, provided comprehensive evidence of HMTM’s efficacy and safety, involving over 3,000 participants. Results presented at the AD/PD™ 2024 Alzheimer’s & Parkinson’s Diseases Conference in Lisbon highlighted HMTM’s potential, including significant reductions in neurofilament light chain (NfL), a biomarker for neurodegeneration, and sustained cognitive improvements over 18 months in MCI patients. Early intervention with HMTM appears crucial, as control group participants who later received the drug could not match the cognitive function of those treated earlier.
HMTM’s potential to change the landscape of Alzheimer’s treatment is significant, offering new hope for patients and their families struggling with this debilitating disease.