Monday, July 01, 2024
TauRx Pharmaceuticals Ltd has submitted a UK Marketing Authorisation Application (MAA) for hydromethylthionine mesylate (HMTM), targeting mild cognitive impairment (MCI-AD) and mild to moderate dementia stages due to Alzheimer's disease (AD). This submission under the Innovative Licensing and Access Pathway (ILAP) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) follows evidence from the Phase 3 LUCIDITY trial and earlier Phase 3 studies. These trials consistently show benefits in cognition decline, daily living activities, and reduced brain shrinkage rates.
Tau aggregation correlates with cognitive decline severity, brain atrophy, and neuron damage in AD. HMTM selectively inhibits tau-protein aggregation in brain nerve cells and enhances brain function through another mechanism.
Professor Claude Wischik, Executive Chairman of TauRx, emphasized, "This submission is pivotal for TauRx, potentially offering new treatment options and hope to patients and families affected by this disease."
HMTM, developed to target tau aggregation in AD, also enhances acetylcholine levels in the hippocampus through an independent mechanism. The Phase 3 trial LUCIDITY, involving over 3,000 subjects, showcased HMTM's robust safety profile and potential for minimal patient and physician burden.
Neurofilament Light Chain (NfL) serves as a biomarker for neurodegeneration, demonstrating significant reduction in the double-blind phase of the LUCIDITY trial at 12 months. Cognitive function improvements sustained over 18 months in MCI underscore the importance of early intervention with effective AD therapies.
Source: businesswire.com
