SINGAPORE, ABERDEEN, SCOTLAND, and SHANGHAI, CHINA 12 April , 2022 – TauRx Therapeutics Ltd, a subsidiary of TauRx Pharmaceuticals Ltd, today announced receipt of investigative new drug (IND) approval from the National Medical Products Administration (NMPA) in China for study TRx-237-801. dMed-Clinipace, a global CRO based in Shanghai, has been selected as the research partner for this study. IND approval was formally given on 10th March 2022 paving the way for TauRx to build on its global strategy to bring to market the first disease modifying treatment for Alzheimer’s disease targeting the tau pathology of Alzheimer’s disease (AD).
This clinical trial will further evaluate the safety and efficacy of TauRx’s oral tau aggregation inhibitor, hydromethylthionine mesylate (referenced as HMTM). It is a 12-month study seeking to complement TauRx’s existing phase 3 trial, LUCIDITY (NCT03446001), which is currently being conducted in North America and Europe and is due to report mid-2022. The study in China will evaluate the same co-primary endpoints for cognition and function as LUCIDITY and span the same wide severity range from minimal to moderate disease.
The new trial has been planned to begin recruitment of around 400 participants and their study partners in Q4 of 2022, across an estimated 30 study sites in China, and is anticipated to complete in Q2 2025.
Professor Claude Wischik, Executive Chairman and Co-Founder of TauRx, commented: “I’m particularly delighted that we are able to proceed with this study. It reflects well on the strong Asian footprint of TauRx, which is incorporated in Singapore and has been financed by a largely Asian shareholder base. Our late Co-Founder, Dr K M Seng, had a vision to bring an effective and accessible treatment for AD to patients in all parts of the world, and we are a step closer to achieving this with the IND approval by the NMPA. We estimate that 60% of the global burden of AD is in Asian countries compared with only 12% in Europe and US combined. We are particularly grateful for the continued loyalty of our shareholders from Singapore, Malaysia, Hong Kong and Indonesia in supporting the expansion of our clinical development program for HMTM. Success in this program will enable TauRx to bring a tau-based treatment to patients spanning a broad range of disease severity from very early to moderate AD.”
“This is a critical and important trial in the path to develop new treatments for a most devastating disease,” stated Dr. Lingshi Tan, CEO of dMed-Clinipace. “With our local expertise, we will provide expert regulatory guidance and timely access to the right patients, helping TauRx to accelerate the delivery of this innovative solution.” dMed-Clinipace has extensive experience in neurological therapies including Alzheimer’s Disease, having conducted over 70 neurology trials with nearly 11,000 patients in the past 5 years.
Aggregation of abnormal tau protein is one of the hallmark pathologies of AD. Tau aggregation and the subsequent formation of tau tangles disrupt neuronal function, a process that begins many years before any symptoms of dementia are seen. Tau pathology correlates strongly with AD severity and the clinical decline commonly seen in patients as they lose memory and other cognitive functions as well as the ability to care for themselves in daily living.
HMTM is already being tested in over 500 patients in the LUCIDITY study, with patients taking doses of either 16mg/day or 8mg/day, or placebo. HMTM is an oral tablet, and the results from the first 12 months of the blinded phase of this study will be available in mid-2022. LUCIDITY will continue to run for a further 12 months to compare earlier versus later initiation of treatment. During this second phase, all patients will receive the recommended16mg/day dose. The China study will compare only the 16mg/day dose against placebo.
The ongoing Lucidity trial is designed to demonstrate statistically significant benefit of HMTM* at a dose of 16mg/day with respect to placebo. It aims to confirm the results seen in patients who had high enough blood levels of the drug at an 8mg/day dose to produce clinically meaningful treatment effects in earlier Phase 3 trials. The 16mg/day dose will ensure that all patients have blood levels high enough for therapeutic benefit. Positive results in the Lucidity trial will support applications for regulatory approval of the drug as the first tau-based disease modifying treatment for mild cognitive impairment due to AD, and mild-moderate AD. HMTM is taken orally and so does not require in-clinic intravenous infusions. Safety data from the extensive studies which have been completed showed that HMTM has an acceptable safety and tolerability profile at doses up to 250mg/day.
* Previously also abbreviated to LMTM or LMTX
About TAURX PHARMACEUTICALS LTD
The company was founded in Singapore in 2002 by Dr. K. M. Seng and Professor Claude Wischik with the aim of developing new treatments and diagnostics for a range of neurodegenerative diseases. TauRx’s headquarters are in Singapore with primary research facilities and operations based in Aberdeen. As the majority of the TauRx board is Asian, the company brings together strong technical expertise in AD and Asian values of compassion, integrity, hard work and financial acumen.
Its research has focused on protein aggregation pathology in Alzheimer’s disease and other neurodegenerative conditions. The company’s tau aggregation inhibitor, hydromethylthionine mesylate (HMTM), is currently the only tau-based experimental drug for AD in late stage clinical development in a Phase 3 trial. HMTM targets abnormal aggregates and fibres of misfolded tau, TDP-43 and synuclein proteins that form inside nerve cells in the brain that damage and ultimately kill neurons in several different neurodegenerative disorders, including AD, Frontotemporal Dementia, Parkinson’s Disease, Lewy Body Dementia and Progressive Supranuclear Palsy.
dMed-Clinipace is a global, full-service contract research organization (CRO) with the largest Asia-Pacific presence. Our approach to clinical research is personal. We deliver a level of collaboration and flexibility not possible in a traditional CRO environment, with an emphasis on personalized services and solutions, regulatory expertise, and therapeutic leadership. Our mission is to improve the way clinical research is performed in major therapeutic areas. We strive to impact the future of drug development and health care by combining the most advanced technology with the highest international clinical standards.
Leona Minellas, Communication Lead
Aspect: The Strategic Communication Experts
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