TauRx Therapeutics Ltd has achieved its target enrolment of 700 subjects with mild Alzheimer’s disease into the second of its two Phase III clinical trials of LMTX™, a tau aggregation inhibitor, for the treatment of Alzheimer’s disease. This multi-centre, placebo-controlled clinical trial (Protocol TRx-237-005) is aimed at assessing the efficacy of LMTX™ in people diagnosed with mild Alzheimer’s disease. The study is also evaluating the safety and pharmacokinetic profile of LMTX™, and incorporates imaging endpoints in all subjects.
In July, TauRx announced that the Company had achieved its target enrolment of 833 subjects into its first Phase III clinical trial (Protocol TRx-237-015); this study recruited subjects with mild and moderate Alzheimer’s disease. The third global study, TauRx’s Phase III clinical trial (Protocol TRx-237-007) in patients with behavioural variant frontotemporal dementia (bvFTD), continues to recruit subjects, and is on track to complete enrolment by early 2015.
Professor Claude Wischik, Chairman and co-founder of TauRx, said “Reaching our enrolment targets for both of our Phase III Alzheimer’s disease clinical trials is a major milestone for our Company and it is particularly apt that we can announce this on World Alzheimer’s Day. This achievement brings us another step closer to our objective to offer the first tau-targeted disease-modifying treatment for Alzheimer’s disease - an important treatment advance for patients.” He added “Having recently participated in the G8 Dementia Summit legacy meetings, I am acutely aware of the call from governments, physicians, carers, patients and international Alzheimer’s groups for innovative treatments to slow or stop the inevitable cognitive decline to dementia. With both of our studies now set for completion in 2016, TauRx may be in the unique position of turning this hope into practical reality in the very near future.”
Dr. Serge Gauthier, MD, FRCPC of the McGill Centre for Studies in Aging, Montreal, Canada, a leading physician investigator participating in both TauRx Phase III clinical trials for Alzheimer’s and TauRx’s bvFTD trial, noted, “Having a tau-targeted treatment that slows or halts the progression of Alzheimer’s will be a breakthrough for people facing this disease worldwide. With many failed attempts in alternative approaches, we could at last be on the right path towards altering the underlying pathology that leads to dementia.”
Professor Wischik attributed the completion of enrolment into the clinical trials to the support of more than 100 global clinical research centres and dedicated physician investigators, a motivated TauRx project team lead by Dr. Jiri Hardlund as well as the contributions of its partner companies. He singled out two partner companies for their efforts in achieving enrolment targets: Worldwide Clinical Trials, a global Clinical Research Organisation that is managing the studies on behalf of TauRx, and MediciGroup®, Inc. [dba MediciGlobal Ltd] a specialty patient recruitment firm that brings innovative approaches to accelerate global patient recruitment and retention for clinical trials.
With both clinical trials in Alzheimer’s disease now fully recruited, TauRx and its partners are turning their attention towards the bvFTD clinical trial. “LMTX™ has potential for the treatment of bvFTD because it targets aggregations of both the tau and TDP-43 proteins, which each account for about half of the cases,” Wischik said. “Patients and families living with bvFTD are encouraged to contact the nearest research centre to be included in this Phase III clinical trial before the window of opportunity closes shortly,” he added.