Life science group TauRx Therapeutics has now enrolled 700 subjects with mild Alzheimer's disease into the second of its two Phase III clinical trials of LMTX, a tau protein aggregation inhibitor intended for the treatment of Alzheimer's disease. This multi-centre, placebo-controlled clinical trial is aimed at assessing the efficacy of LMTX in people diagnosed with mild Alzheimer's. The study will also evaluate 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. This study recruited subjects with mild and moderate Alzheimer's disease. The third global study, TauRx's Phase III clinical trial 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. 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, said: “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.”
The completed enrolment is the result of the collective work of 100 global clinical research centres and dedicated physician investigators, a TauRx project team, as well as contributions from its partner companies. Worldwide Clinical Trials, a global clinical research organisation, is managing the studies on behalf of TauRx, whilst MediciGroup, a specialty patient recruitment firm provided support with sourcing the subjects.