TauRx to present 24 months data from phase III clinical rial of HMTM in Alzheimer’s disease at AD/PD 2024 conference in March in Lisbon
TauRx Pharmaceuticals Ltd., a global leader in Tau-based research in Alzheimer’s disease (AD), has announced that the company will present the 24 months data from its phase III LUCIDITY clinical trial of hydromethylthionine mesylate (HMTM) at the upcoming AD/PD 2024 Alzheimer's & Parkinson's Diseases Conference from 5-9 March 2024, in Lisbon, Portugal.
Professor Claude Wischik, co-founder, CEO and executive chairman of TauRx will present data including details of the final 12 months open label phase of the study indicating maintenance of subjects with mild cognitive impairment due to Alzheimer’s at baseline cognitive scores. A panel, moderated by Dr. Serge Gauthier and including Professor Henrik Zetterberg, Professor Alistair Burns, and Dr. David Watson, will discuss the relevancy of these data and the potential impact of HMTM on people living with Alzheimer’s disease.
“We believe that presentation and discussion of this data represents an important step in our mission to bring people living with Alzheimer’s and their loved ones a safe and effective oral treatment that they will be able to access,” said Professor Claude Wischik. “Alzheimer’s disease is a global problem, one that impacts millions of people in some way at some point, and we are determined to help those impacted by this disease.”
HMTM is designed for early intervention to modify the disease, slowing progression of AD. If approved, HMTM will be the first oral, anti-tau therapy with a robust safety profile requiring minimal testing and treatment monitoring. This simplified profile will promote accessibility and affordability for people living with Alzheimer’s.
At the conference, TauRx will present the data during a moderated panel discussion at 13:50 CET on 7 March “24-month topline results from Phase III LUCIDITY trial in AD show combined disease-modifying and symptomatic activity for HMTM”) and host an additional question and answer session on 9 March. Professor Wischik will also participate in a forum discussion “Anti-tau therapies in clinical trials—what are the challenges and opportunities for a rational therapy?” on 8th March.
TauRx has initiated regulatory engagement in the UK and the US for intended product approval. Other territories will follow in line with plans to scale commercialisation of HMTM.
Through dedicated research programs, it is understood that certain age-related factors lead to misfolding and aggregation of tau proteins, and the subsequent formation of tau tangles in Alzheimer’s. Pathological aggregation of tau protein disrupts and damages neuronal function. The process begins many years before symptoms of dementia are seen. Tau pathology has been proven to correlate with the clinical decline (loss of memory and ability to care for oneself) commonly seen in people with Alzheimer’s, establishing it as an important target for treatment. HMTM is primarily a tau aggregation inhibitor, which effectively crosses the blood brain barrier to target the source of this damaging process. Its secondary pharmacological action is symptomatic through increasing acetylcholine levels in parts of the brain essential for memory functions.
Completed in June 2023, LUCIDITY was a double-blind randomised controlled Phase III clinical trial comparing change over 12 months in cognitive, functional and brain atrophy outcomes at HMTM doses of 16 mg/day, 8 mg/day and methylthioninium chloride (MTC) at a dose of 4 mg twice weekly as a control in a 4:1:4 randomisation, with a subsequent 12 month blinded open-label extension phase in which all participants received 16 mg/day.
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