ABERDEEN, Scotland and SINGAPORE, 15 July 2014 – TauRx Therapeutics Ltd today 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.
“Achieving our target enrolment in the first of our two Phase III clinical trials for Alzheimer’s is an important milestone for our company,” said Professor Claude Wischik, Chairman of TauRx. “It moves us another step closer to our objective of bringing the first tau-targeted and genuinely disease-modifying treatment for Alzheimer’s disease to patients.” Professor Wischik added that “Awareness of our clinical trial has been high in the light of a string of failures of trials targeting ?-amyloid. Interest from physicians, carers, patients and international Alzheimer’s groups demonstrates the need for innovative treatments that halt or slow the progression of Alzheimer’s so that, in the near future, people with Alzheimer’s may be able to live without fear of an inevitable decline into dementia.”
Prof. Wischik credited the completion of enrolment for the TRx-237-015 study to the outstanding support of more than 100 global clinical research centres and dedicated physician investigators, a motivated TauRx project team as well as the contributions of its partner companies. In particular, he singled out the efforts put into patient recruitment by Worldwide Clinical Trials [WCT], a global Clinical Research Organisation [CRO] that is managing the studies on behalf of TauRx, and MediciGroup®, Inc. [dba MediciGlobal Ltd] who specialise in innovative approaches to global patient recruitment and retention.
TauRx and its partner firms are now turning their attention to completing enrolment for its other two ongoing Phase III clinical trials: TRx-237-005 for patients with mild Alzheimer’s and TRx-237-007 for patients with behavioural variant frontotemporal dementia (bvFTD). “LMTX has particular interest for bvFTD because it targets the aggregation of both tau protein and TDP-43 proteins, which each account for about half the cases. Since the opportunity for patients with Alzheimer’s to participate in the remaining AD study is closing fast, we are continuing our outreach initiatives to reach mild AD patients. Although the bvFTD study has somewhat longer to run, it is important for patients with this condition to connect with the closest research centres currently enrolling if they wish to be included in this clinical trial,” Wischik said.
Dr. Emer MacSweeney, Re:Cognition Health, London, a leading Physician Investigator participating in both TauRx clinical trials for Alzheimer’s and the bvFTD trial, noted that there are no approved treatments currently for Alzheimer’s disease that either slow or halt its progression. “Achieving this feat with LMTX™ would truly be a medical milestone,” Dr. MacSweeney said. She added, “While there are many Alzheimer’s clinical trials ongoing, TauRx is the only company to bring a tau aggregation inhibitor to late-stage clinical development. Judging by the results of TauRx’s substantial body of scientific research in this field, we could at last be on the right path towards altering the underlying pathology that leads to dementia.”
People and families living with mild Alzheimer's are encouraged to visit the TauRx website at www.taurx.com to see if they meet the medical criteria for either the TRx-237-005 [mild Alzheimer's] or TRx-237-007 [behavioural vaiant frontotemporal dementia - bvFTD] trials.
About the TRx-237-015 clinical trial for mild to moderate Alzheimer’s
This Phase III double-blind, placebo-controlled trial (TRx-237-015) 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.
About the TRx-237-005 clinical trial for mild Alzheimer’s
This Phase III double-blind, placebo-controlled clinical trial will assess the safety and efficacy of LMTX™ in up to 700 patients diagnosed with mild Alzheimer’s. The study involves approximately 100 clinical sites primarily in the U.S. and Europe. The clinical efficacy measures are the same as for TRx-237-015. In addition reduction in decline in glucose uptake in the temporal lobe is being measured by FDG/PET imaging.
About the TRx-237-007 clinical trial for mild Alzheimer’s
This Phase III double-blind placebo-controlled study is designed to evaluate the safety and efficacy of LMTX™ in patients diagnosed with behavioural variant Frontotemporal Dementia (bvFTD). The treatment period is 12 months. The study is planned to involve 180 patients and ~70 study sites located in Canada, U.S., U.K., Germany, The Netherlands, Australia and Singapore. The main measures of efficacy are the change in study subjects’ performance at the beginning and the end of the study in two commonly used clinical assessments: (1) the Addenbrookes’s Cognitive Examination (Revised), known as ACE-R; and (2) the Modified Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change, known as ADCS-CGIC.
About TauRx Therapeutics Ltd
TauRx Therapeutics Ltd is a spin-out company from the University of Aberdeen, Scotland, and was established in Singapore in 2002 with the aim of developing new treatments and diagnostics for a range of neurodegenerative diseases. The company’s tau aggregation inhibitor, LMTX™, is currently in global Phase 3 clinical trials for Alzheimer’s and Frontotemporal Dementia (FTD). LMTX™ targets aggregates of abnormal fibres of tau protein that form inside nerve cells in the brain, giving rise to ‘tau tangles’. TauRx’s primary research facilities are headquartered in Aberdeen. For more information, please visit: http://www.taurx.com.