TauRx Pharmaceuticals has submitted a Marketing Authorisation Application (MAA) in the UK for hydromethylthionine mesylate (HMTM), a potential treatment for Alzheimer’s disease (AD). HMTM targets the accumulation of tau proteins, a hallmark of AD.
The application is supported by data from Phase 3 trials, including the LUCIDITY trial, which demonstrated benefits in cognitive function and reduced brain shrinkage. HMTM inhibits tau aggregation and enhances brain activity.
UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has designated HMTM for the Innovative Licensing and Access Pathway (ILAP), which could result in HMTM becoming the first oral treatment available in the UK specifically targeting tau pathology.
If approved, HMTM could offer a new treatment option for patients with mild cognitive impairment (MCI-AD) and mild to moderate AD. It has a strong safety profile and can be administered orally with minimal burden.
Dr. Claude Wischik, Executive Chairman of TauRx, emphasized the milestone, stating, “This step brings hope to patients and families affected by this devastating disease.”
HMTM is a potential oral therapy designed to target tau aggregation in AD. It also has a tau-independent mode of action, increasing acetylcholine levels, which is crucial for cognitive function.
The Phase 3 LUCIDITY trial showed a reduction in neurodegeneration as measured by Neurofilament Light Chain (NfL) and sustained improvement in cognitive function over 18 months in MCI patients.
About TauRx Pharmaceuticals Ltd
TauRx Pharmaceuticals was established in 2002 and is dedicated to developing treatments and diagnostics for Alzheimer’s disease. Its research facilities and operations are based in Aberdeen, UK.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
