TauRx Alzheimer's Disease Drug Approved in China Phase III; dMed-Clinipace as Partner

Taurx Therapeutics Ltd, a subsidiary of TauRx Pharmaceuticals Ltd (Taurx Pharmaceuticals), announced that it has received approval from the National Medical Products Administration (NMPA) of China for an Investigational New Drug Application (IND) for the study of Trx-237-801
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dMed-Clinipace, a global clinical contract research organization (CRO) headquartered in Shanghai, has been selected as a partner for this study
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The NDA was officially approved on March 10, 2022, which further strengthens TauRx's global strategy and brings to market the first Alzheimer's disease-modifying therapy targeting Alzheimer's disease (AD) tau protein pathology laid a solid foundation
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This clinical trial will further evaluate the safety and efficacy of TauRx's oral tau aggregation inhibitor, hydromethylthionine mesylate (HMTM)
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This is a 12-month study designed to complement TauRx's current Phase III clinical trial LUCIDITY (NCT03446001) in Europe and the United States, with results expected in mid-2022
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The Chinese study, like LUCIDITY, covered patients with mild cognitive impairment and mild-to-moderate Alzheimer's disease, and will also assess the same composite primary endpoint of cognition and function
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The new trial is scheduled to begin enrolling approximately 400 subjects in the fourth quarter of 2022, spread across approximately 30 research centers in China, and is expected to be completed in the second quarter of 2025
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Professor Claude Wischik, Executive Chairman and Co-Founder of TauRx, commented: "I am particularly pleased that we have been able to advance this research
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This is a good reflection of TauRx's strong network in Asia, TauRx is incorporated in Singapore and primarily contributed by the Asian shareholder base financing
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The vision of our late co-founder Dr.
KM Seng (Doctor Xin Guangming) was to bring an effective and accessible Alzheimer's disease (AD) treatment to patients around the world, with China's national medicine With the approval of the New Drug Clinical Trial Application (NMPA), we are one step closer to achieving this goal
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We estimate that 60% of the global Alzheimer's disease (AD) burden is in Asian countries, compared to just 12% in Europe and the United States
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We are particularly grateful to our various shareholders from Singapore, Malaysia, Hong Kong and Indonesia for their continued support in expanding our HMTM clinical development program
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The success of this project will enable TauRx to bring tau-based therapy to a broad Alzheimer's disease (AD) patient population, from very early to moderately symptomatic disease patients
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"This is a crucial trial as we probe and develop a new treatment for a particularly dire disease," said Dr.
Lingshi Tan, CEO of dMed-Clinipace
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With our professional team in China, we will provide regulatory expert-level guidance to assist TauRx in communicating with the State Drug Administration, and find suitable patients in a timely manner to help TauRx accelerate the delivery of this innovative treatment to patients
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"dMed-Clinipace has extensive clinical trial experience in the field of central neurology treatments including Alzheimer's disease, and has participated in more than 70 clinical trials in the field of neuroscience enrolling nearly 11,000 patients over the past 5 years.
Test.
Aberrant
tau aggregation is one of the hallmark pathologies of Alzheimer's disease (AD).

Tau aggregation and subsequent formation of tau tangles disrupt neuronal function, a process that precedes any dementia symptoms much It began in
2010.
Tau pathology is closely associated with the severity and clinical deterioration of Alzheimer's disease (AD), which is commonly seen in patients with progressive loss of memory, other cognitive functions, and activities of daily living.

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In the LUCIDITY study, HMTM has been tested on more than 500 patients at doses of 16 mg/day, 8 mg/day, or placebo
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HMTM is an oral tablet and results from the first 12-month blinding phase of the study will be published in mid-2022
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LUCIDITY will continue with the next 12-month study phase to compare early versus late initiation of treatment
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In the second phase, all patients will be dosed at the recommended dose of 16 mg/day
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The Chinese study will only compare the 16 mg/day dose with placebo
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About LUCIDITY The ongoing Lucidity trial is designed to demonstrate a statistically significant benefit of the 16 mg/day dose of HMTM* relative to placebo
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The aim was to demonstrate the results seen in early phase III trials in patients who achieved sufficiently high plasma drug concentrations at the 8 mg/day dose to produce clinically meaningful therapeutic effects
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The 16 mg/day dose will ensure that all patients have plasma concentrations high enough to yield therapeutic benefit
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Positive results from the Lucidity trial will support the drug's marketing application as the first tau-based disease-modifying therapy for the treatment of mild cognitive impairment and mild-to-moderate Alzheimer's disease caused by Alzheimer's disease (AD).
disease (AD)
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HMTM is administered orally, so it does not require an IV infusion in a clinic or hospital
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Safety data from extensive completed studies indicate that HMTM has an acceptable safety and tolerability profile at doses up to 250 mg/day
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