Date: 2014-07-15
Type of information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: TauRx Therapeutics (Singapore - UK)
Product: LMTX™ (leuco-methylthioninium)
Action
mechanism: LMTX™ is a tau aggregation inhibitor (TAI). Methylthioninium chloride (MTC) was the first TAI studied by Professor Wischik and colleagues. The drug was tested in vivo in two transgenic mouse models. In both studies, MTC was able to reverse the behavioural and pathological effects arising from tau pathology. The team concluded that MTC had the potential not only to slow the rate of Alzheimer’s progression, but may even halt it and restore neuronal function, particularly at early stages of the disease. This formed the basis for further development of TauRx’s first generation TAI, rember®, and subsequent follow-on molecules. TauRx’s first-generation TAI, rember®, was a proprietary form of MTC and the first TAI to be tested in clinical trials for Alzheimer’s. An improved version with enhanced bioavailability and tolerability has been developed. The result was LMTX™ (leuco-methylthioninium), a completely new chemical entity that delivers the same active moiety into the bloodstream as its predecessor, rember® but in a more efficient manner. The TauRx team has conducted several animal studies evaluating the pharmacokinetic properties and bioavailability of LMTX™. Additionally, they have determined the compound’s efficacy on tau pathology in two tau-transgenic mouse models which produce tau pathology. In these studies, they also measured the brain concentration at which effect on tau pathology is observed, and related this back to plasma levels in humans and plasma and brain levels in pigs.
Disease: Alzheimer\'s disease
Therapeutic area: Neurodegenerative diseases
Country: America, Europe, Russia, Australia, Southeast Asia
Trial
details: The TRx-237-015 clinical trial for mild to moderate Alzheimer’s disease is a phase III double-blind, placebo-controlled trial. It is designed to assess the safety and efficacy of LMTX™ in patients diagnosed with mild to moderate Alzheimer’s disease. The treatment period is 15 months. The main measures are the change in study subjects’ cognitive performance at the beginning and the end of the study in three commonly used clinical assessments: The Alzheimer’s Disease Assessment Scale – Cognitive Subscale, known as ADAS-cog11; The Modified Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change, known as ADCS-CGIC and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living scale.
Latest
news: * On July 15, 2014, TauRx Therapeutics announced it has achieved its target enrolment of 833 subjects into one of its two ongoing multi-centre Phase III clinical trials of LMTX™, a tau aggregation inhibitor, for the treatment of Alzheimer’s Disease [AD]. This placebo-controlled clinical trial (Protocol TRx-237-015) has recruited subjects in North America, Europe, Russia, Australia and Southeast Asia and is aimed at assessing the efficacy of LMTX™ in slowing the progression of Alzheimer’s in people diagnosed with mild to moderate disease. The study is also evaluating the safety and pharmacokinetic profile of LMTX™, as well as examining the effect on imaging end-points in a subset of subjects. TauRx’s other Phase III clinical trial (Protocol TRx-237-005) with a target enrolment of 700 subjects diagnosed with mild Alzheimer’s is already 80% recruited and is expected to complete its enrolment in the next 2-3 months.
