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ExonHit Gets Regulatory Approval to Initiate a Phase 2 Clinical Trial for EHT 0202 in Alzheimer's Disease

PARIS, December 20 /PRNewswire-FirstCall/ -- ExonHit Therapeutics, a drug and diagnostic discovery company, announced today that it has obtained a regulatory approval to initiate a Phase 2 clinical trial of its therapeutic compound, EHT 0202, in patients with Alzheimer's disease. EHT 0202 is a compound, with a novel mechanism of action, which has shown benefits on memory and neuronal loss.

This will be the first Phase 2 clinical trial for EHT 0202, it will be a multi-center, double-blind trial, in which 135 patients will be randomized. The trial's primary endpoint is the safety and tolerability of the product when it is administered orally for a 3 month period in conjunction with an acetylcholinesterase inhibitor, the most common therapy used to treat Alzheimer's disease. The trial will also provide preliminary data on EHT 0202's clinical efficacy, in particular regarding its effects on cognition and behaviour.

Alzheimer's disease is a major public heath issue, with a patient population that is expected to grow rapidly in the near future because of the aging population. It is estimated that over 25 million people worldwide, including 860 thousand in France, suffer from Alzheimer's disease or assimilated pathologies. "Medical research has made significant progress in that field, as shown by the number of therapies now available, however their efficacy remains limited. There is thus a significant need for new and innovative therapies, which will not only provide symptomatic relief but also modify the disease's evolution by slowing or even stopping its underlying neurodegenerative process." stated Olivier Sol, MD, Clinical Director ExonHit.

"EHT 0202's pharmacological properties, linked to its GABA-A receptor modulating role, offer a promising approach to restoring the CNS processes that are altered in Alzheimer's disease, such as neuron degeneration and cognition. Indeed, this compound redirects the processing of APP (Amyloid Precursor Protein), which plays a pivotal role in the evolution of Alzheimer's disease, towards a normal route. The Phase 2 trial for EHT 0202 will allow us to study this compound's therapeutic effect in Alzheimer's disease patients" underlined Professor Bruno Vellas, Department of Geriatric Medicine, Casselardit hospital, Toulouse, France.

Bruno Tocque, President of the Management Board of ExonHit said "We are delighted to initiate our Phase 2 clinical trial for EHT 0202. We also aim, through that study, to further illustrate the clinical utility of our blood-based diagnostic for Alzheimer's disease. This milestone reflects ExonHit's strategy, which is to provide therapeutic and diagnostic solutions in chronic diseases such as Alzheimer's disease".

About ExonHit Therapeutics

ExonHit Therapeutics is the world's leader in the analysis of alternative RNA splicing, a process which when deregulated plays a key role in the onset of various diseases.

ExonHit has a multi-component commercial strategy to capture the maximum value from its leadership in alternative splicing. The Company is already generating revenues from a new generation of microarrays, SpliceArrayTM family of products that enable life science researchers to detect crucial disease-associated information. These products are marketed worldwide in conjunction with Agilent and Affymetrix. In the field of diagnostics, ExonHit has a major collaboration with bioMerieux to develop completely novel predictive blood-based cancer diagnostics, which could play a key role in improving the treatment of breast cancer and other major cancers and develops its own projects for the detection of other chronic diseases such as Alzheimer's disease or atherosclerosis.

In parallel, ExonHit is developing its own therapeutic pipeline in the field of neurodegenerative diseases and cancer. The Company has advanced drug candidates into clinical trials and is evaluating several promising pre-clinical compounds. ExonHit also has a strategic partnership with Allergan, to discover and develop new therapeutics in the areas of pain, neurological diseases and ophthalmology. This collaboration provides on-going research funding to ExonHit.

Founded in 1997, ExonHit is headquartered in Paris, France and has a U.S. facility in Gaithersburg, Maryland. The Company is listed on Alternext of Euronext Paris (ticker: ALEHT; ISIN: FR0004054427) since November 17, 2005.

This press release includes only summary information and does not purport to be comprehensive. The projections, forecast and estimates of ExonHit Therapeutics which may be contained herein are for illustrative purposes only and are based on management's current views and assumptions. Such projections, forecast and estimates involve known and unknown risks and uncertainties, as described at Section 4.2 "Facteurs de risque" (Risk Factors) of the Document de Base available on ExonHit Therapeutics' website (, that may cause actual results, performance or events to differ materially from those anticipated in the summary information.

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.


ExonHit Therapeutics

Bruno Tocque, C.E.O.

Philippe Rousseau, C.F.O.

Tel: +33-1-58-05-47-00

SOURCE ExonHit Therapeutics SA
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