TauRx Submits UK Marketing Authorisation Application for HMTM as a Treatment for Alzheimers Disease

Aberdeen, Scotland:
TauRx Pharmaceuticals Ltd, a global leader in tau-based research in Alzheimer’s disease (AD), has announced the submission of a UK Marketing Authorisation Application (MAA) for hydromethylthionine mesylate (HMTM) for treatment of mild cognitive impairment (MCI-AD) and mild to moderate stages of dementia due to Alzheimer’s disease.

HMTM has been designated by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the Innovative Licensing and Access Pathway (ILAP). If successful, the UK could be the first country in which an accessible, safe, oral treatment, which targets the hallmark tau pathology of the disease, becomes available to patients.

The MAA is based on the totality of evidence available from the recently released 24-month Phase 3 LUCIDITY data and two earlier Phase 3 trials in mild to moderate AD. These studies have been consistent in showing benefit on measures of decline in cognition, ability to perform normal activities of daily living, and reduction in the rate of brain shrinkage.

Tau aggregation is strongly correlated with the rate and severity of cognitive decline, brain atrophy, and the damage to neurons responsible for the characteristic neurodegeneration of the disease. HMTM acts by selectively inhibiting the aggregation of tau-protein in brain nerve cells. It also has a second mode of action which results in enhancement of brain functioning.

Commenting on the submission, Professor Claude Wischik, Executive Chairman of TauRx, said: “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.”