PARIS - (Business Wire) Regulatory News: ExonHit Therapeutics (Paris:ALEHT) together with Toulouse University Hospital and l’Institut de Recherche Pierre Fabre (IRPF) will participate in the Multidomain Alzheimer Preventive Trial (MAPT). The study’s main objective is to assess the efficacy of a multidomain (nutrition, physical exercise, cognitive stimulation) intervention associated with an omega-3 treatment in preventing the decline of cognitive functions in aged and frail individuals.
“We are going to apply our validated AclarusDxTM diagnostic platform to the study samples in order to identify early blood biomarkers of Alzheimer’s disease,” commented Loïc Maurel, M.D., President of the Management Board of ExonHit Therapeutics. He added: “Access to such biomarkers would be a major asset for developing new drugs against this disease.”
The clinical study, which includes several memory centers in France, is lead by Professor Bruno Vellas, M.D., Head of the Alzheimer’s Disease Clinical Research Center and of the Gérontopôle, Toulouse University Hospital, France.
“Early detection of Alzheimer’s disease, before signs of dementia appear and taking action at a very early stage is key to an improved patient care,” stated Professor Vellas.
Over the course of 3 years, 1,200 frail individuals, of both genders and aged 70 or more will be monitored. During this period, the status of their cognitive functions and of their functional capacity will be assessed in order to identify the ones who evolve towards dementia, in particular one of an Alzheimer’s type, and to evaluate the preventive measures that are tested.
| Annual blood samplings will allow for transcriptome analysis in order to: |
| | | (i) | | Develop a signature that will identify asymptomatic subjects at risk of having an impairment of their cognitive functions, which could evolve towards a dementia (Alzheimer’s or other) and |
| | (ii) | | Search for new biological markers for the diagnosis and prognosis of cognitive diseases such as Alzheimer’s, with the long-term objective of developing new, more effective treatments. |
Financial terms of the 3-party agreement were not disclosed.
About the MAPT study
The primary objective of the study is to assess the efficacy of adding omega-3 fatty acids, or of a multidomain intervention, or of their combination on the evolution of an aged and frail person’s cognitive functions. A frail person is defined by one of the following criteria: (i) a subjective cognitive complaint spontaneously declared to the family doctor, or (ii) an inability to perform a key daily activity, or (iii) a slow walk.
1,200 frail individuals of both genders and aged 70 or more, are randomized in 4 groups: (i) group omega-3 fatty acids, (ii) group multidomain intervention + placebo, (iii) group multidomain intervention + omega-3 fatty acids, (iv) placebo group. The primary objective is the evaluation of the cognitive functions. Secondary objectives are: (i) the evaluation of the efficacy of each intervention strategy on the evolution of the functional capacities and on the prevention of dependence, (ii) the safety evaluation and long-term tolerance of omega-3 fatty acids, (iii) the study of compliance and aherence to the multidomain intervention program (1).
Study completion is planned in 2013 and publication of results, in 2014.
About Alzheimer’s disease
Alzheimer’s disease is a progressive neurodegenerative condition that is the most frequent cause of dementia in the aging population. An estimated 26.6 million people worldwide had Alzheimer in 2006. This number is anticipated to quadruple by 2050 to more than 100 million; 1 in 85 persons worldwide will be living with the disease (2). In France alone, 800,000 people, or 18% of people above 75 years old, have Alzheimer’s disease (3).
About ExonHit Therapeutics
ExonHit Therapeutics (Alternext: ALEHT) is a fast emerging healthcare player active in both therapeutics and diagnostics. The Company is applying its proprietary technology, based on the analysis of alternative RNA splicing, to develop innovative molecular diagnostic tests and therapeutics for neurodegenerative and cancer indications. ExonHit has a balanced investment strategy with internal development programs and strategic collaborations, in particular with bioMérieux and Allergan.
ExonHit is headquartered in Paris, France and has U.S. offices in Gaithersburg, Maryland. The Company is listed on Alternext of NYSE Euronext Paris. For more information, please visit http://www.exonhit.com.
Disclaimer
This press release contains elements that are not historical facts including, without limitation, certain statements on future expectations and other forward-looking statements. Such statements are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those anticipated.
In addition, ExonHit Therapeutics, its shareholders, and its affiliates, directors, officers, advisors and employees have not verified the accuracy of, and make no representations or warranties in relation to, statistical data or predictions contained in this press release that were taken or derived from third party sources or industry publications, and such statistical data and predictions are used in this press release for information purposes only.
Finally, this press release may be drafted in the French and English languages. In an event of differences between the texts, the French language version shall prevail.
References
(1) Gillette-Guyonnet S, Andrieu S, Dantoine T, Dartigues JF, Touchon J, Vellas B; MAPT STUDY GROUP. Commentary on a roadmap for the prevention of dementia II. Leon Thal Symposium 2008. “The Multidomain Alzheimer Preventive Trial (MAPT): a new approach to the prevention of Alzheimer’s disease. Dement. 2009 Mar; 5 (2): 114-21
(2) Brookmeyer R, Johnson E, Ziegler-Graham K, MH Arrighi (July 2007). "Forecasting the global burden of Alzheimer’s disease". Alzheimer's and Dementia 3 (3): 186–91
(3) Plan Maladie d’Alzheimer 2004-2007- Ministère des solidarités, de la santé et de la famille
ExonHit Therapeutics
Media
Corinne Hoff, +33 1 58 05 47 04
corinne.hoff@exonhit.com
or
ALIZE RP
Caroline Carmagnol, + 33 6 64 18 99 59
caroline@alizerp.com
or
Investors
Loïc Maurel, +33 1 53 94 77 00
loic.maurel@exonhit.com
