Singapore, 15th December 2010: TauRx Pharmaceuticals Ltd (“TauRx”), a leader in the discovery and development of drugs and diagnostics that provide new treatment options for Alzheimer’s and other neurodegenerative diseases, announced that it has been granted a European patent for its lead compound LMTX, a next generation treatment for Alzheimer’s and other neurodegenerative diseases associated with Tau protein mis-folding.
TauRx has also received a US notification of allowance for a similar patent. The EU patent (EP2013191,extending until 2027) claims describe LMTX, a novel chemical entity and second generation Tau Aggregation Inhibitor, for the prevention and treatment of Alzheimer’s and other neurodegenerative diseases associated with Tau protein mis-folding. The patent further strengthens the company’s IP portfolio in this commercially valuable but highly underserved field.
LMTX is in preparation to enter Phase III trials. TauRx’s data suggests that LMTX works by reducing levels of aggregated or mis-folded Tau proteins, which are intimately associated with the cause of and the progressive neurodegeneration of Alzheimer’s disease.
TauRx’s Tau Aggregation Inhibitors (TAI’s) offer a major advance over existing medicines which only transiently address the symptoms of AD and related diseases and cannot slow their progression. Phase III confirmation of the drug’s disease modifying capability combined with its longer than average period of patent protection positions LMTX as a unique and valuable asset within TauRx’s portfolio.
LMTX shares the same active moiety (methylthioninium (MT)) and mode of action as, TauRx’s first generation Tau Aggregation Inhibitor, rember® but is designed to have better bioavailability and tolerability. The rember® phase II clinical trials delivered an 80% reduction in the rate of Alzheimer’s disease progression and provided the first clinical demonstration that a new therapy targeting Tau protein aggregation could dramatically reduce the rate of progression of this deadly disease. The LMTX family also has activity against synuclein aggregation, another protein misfolding disorder leading to Parkinson’s disease, offering potential for development in this indication.
Commenting on the patent, Professor Claude Wischik, Executive Chairman of TauRx, said: “This patent is a tremendous validation of TauRx’s world leading position in developing therapies for neurodegenerative disorders by attacking the root cause of protein mis-folding. Our LMTX programme is poised for Phase III clinical trials in Alzheimer’s disease and has a good chance of becoming one of the first–to-market disease modifying therapies for Alzheimer’s.”
In addition, patent applications have been granted in Eurasia (South Korean Patent No. 10-0983301) and Hong Kong (Hong Kong Patent No. 1126480B) and a Notice of Allowance has been received in the US, with applications pending in certain other countries.
Details of the LMTX trial design as well as a recent collaborative agreement with Bayer Schering Pharma AG, to develop diagnostics for pre-symptomatic Alzheimer’s diseases, will be outlined by Professor Claude Wischik, Executive Chairman of TauRx at the 4th Annual Alzheimer’s Drug Development Summit, Washington, DC on December 15th. (http://www.cbinet.com/show_conference.cfm?confcode=PC10188)
About TauRx Pharmaceuticals
TauRx Pharmaceuticals (TauRx) is an international leader in the discovery and development of drugs and diagnostics that provide new treatment options for Alzheimer’s and other neurodegenerative diseases that are associated with protein mis-folding.
TauRx’s therapies aim to delay, stop or prevent neurodegenerative diseases. The Company’s lead programmes focus on LMTX, a second generation Tau-Aggregation inhibitor (TAI) which is poised to commence pivotal phase III clinical trials for Alzheimer’s disease and phaseII/III trials for the orphan indication Fronto Temporal Dementia. The Company is also developing drugs against Parkinson’s disease. TRx018 is a nonclinical stage compound that attacks disease-related synuclein protein folding errors and has shown promise in Parkinson disease models. Additional compounds are in earlier stages of development.
TauRx is committed to developing non-invasive diagnostics to detect neurodegenerative disease susceptibility, confirm the stage of a disease, and monitor the effects of therapy. In collaboration with Bayer Schering Pharma AG, TauRx is developing specific imaging agents to aid in the diagnostics and management of Alzheimer’s disease using brain-imaging technology. Such a tool could also be used to detect presymptomatic disease, paving the way for preventative therapy and providing a paradigm shift in the management of Alzheimer’s and other Tauopathies.
The Company’s comprehensive platform technology comprises a wide range of proprietary in vitro and in vivo assays, disease models and medicinal chemistry, enabling rapid transition from concept through to high purity product for target studies and candidate drug discovery and development.
TauRx’s corporate headquarters are in Singapore with R&D facilities in Aberdeen (Wistar Labs) and Berlin. The company is privately held and has raised $128 million to date. The Company’s critical assays, methodology, reagents and drug candidates are protected by a robust patent estate.
For more information, visit: www.taurx.com
About LMTX
The stable reduced form of Leuco-methylthionium (LMT) is one of the compounds in the class of reduced Methythioninium Chlorides (also known as methylene blue). LMT has greater stability, solubility and tolerability than rember®, which TauRx has used successfully in a Phase II clinical trial.
Tau Inhibitors and Alzheimer’s Disease
TauRx’s scientists discovered that neurofibrillary tangles, a hallmark of Alzheimer’s disease are composed predominately of Tau protein. This protein aggregation correlates with Alzheimer’s disease progression and starts to form 10-20 years before disease symptoms develop. The Tau disease aggregation process starts with the formation of early stage pre-tangle Tau aggregates (“oligomers”) which are self catalysing and toxic. During disease progression there is an exponential increase in toxic Tau oligomers and aggregates which interfere with normal cell function and eventually kill the brain cell (neuron).
TauRx’s Tau Aggregation Inhibitors are the only clinical or preclinical stage therapeutics directed against tau aggregation that dissolve Tau aggregates and block abnormal Tau aggregation without interfering with normal Tau function. They therefore have the potential to deliver long term benefits to patients with Alzheimer’s disease.
Alzheimer ’s disease – statistics Alzheimer’s disease, the most common form of dementia, is an irreversible, neurodegenerative disorder characterized by the progressive loss of memory and thinking skills. In 2007 approximately 26 million people were diagnosed with Alzheimer’s Disease worldwide, based on clinical symptoms, which represents 10% of the worldwide population over the age of 65 and as many as 50% of those over the age of 85. These figures are expected to quadruple by 2050 to about 106 million people – one in 85 of the worldwide population. These percentages would increase tremendously if those with early stages of dementia were included. The social and financial costs of this disease are enormous. In the U.S. alone, in2008 AD cost the government’s healthcare program, Medicare, $94 billion, and is expected to reach $189 billion by 2015, $294 billion by 2025 and more than $1 trillion by 2050.
The disease leads to the death of brain cells and is characterised by the appearance of ‘plaques’ and ‘tangles’ in the brain’s structure. A key protein involved in disease progression is the Tau protein of which the tangles are composed. TauRx’s world-leading expertise is in understanding the function of this protein and how to stop it causing tangles in the brain.
Alzheimer’s disease is expected to affect 100 million people by 2050, making it a key area of unmet medical need and a substantial commercial opportunity. Disease related drug sales for Alzheimer’s reached over US $ 4.7 billion in 2009 in the seven major markets and is expected to reach US$11.9 billion by 2019.
About the European Patent EP2013191, granted 18 August 2010 by the European Patent Office to TauRx Pharmaceutical Group Company, WisTa Laboratories Ltd, covers “3,7-diamino-10H-phenothiazine salts and their use. The patent describes the invention of certain stably reduced phenothiazine compounds, which, when in the acidic condition so the gut, are transformed into therapeutically active forms. The patent application has also been granted in Eurasia (South Korean Patent No. 10-0983301), Hong Kong (Hong Kong Patent No. 1126480B), and received on 19 October a Notice of Allowance in the US. Applications are pending in several other countries.
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