PARIS, November 23 /PRNewswire-FirstCall/ -- ExonHit Therapeutics, S.A. (Alternext : ALEHT), a drug and diagnostic discovery company, has been focusing its research operations on the identification of biomarkers that enable screening for the onset and development of Alzheimer’s disease and for the discovery of drugs that may change the course of the disease. These operations are conducted in-house in synergy with those conducted with Allergan Inc., which cover neurodegenerative diseases. This combined effort thus constituting a competitive research program.
ExonHit Therapeutics has always been convinced that companion diagnostics should facilitate development of drugs throughout the different clinical phases and on the market. ExonHit Therapeutics announces today, that it has demonstrated that its proprietary molecule, EHT 0202, leads to the production of a blood protein that is directly linked to the positive impact of the EHT 0202 on the symptoms and evolution of Alzheimer’s disease. This discovery has recently been patented and will help to recruit, for clinical trials, patients with Alzheimer’s disease who could respond to the administration of EHT 0202.
One of the characteristics of Alzheimer’s disease is the presence, in the brain, of senile plaques composed of beta-amyloid peptide aggregates. These senile plaques cause the neuronal death observed in discrete regions of the brain in which cognitive functions occur. ExonHit’s scientists have discovered two series of synthetic molecules, one of which is the EHT 0202. It not only protects against the toxicity and decreases the formation of beta-amyloid peptide aggregates by inducing the production of a neuroprotective peptide called sAPP alpha but also improves cognitive performances. The doses of EHT 0202 that can be reached in humans correspond to doses that fully enable the improvement of cognitive performances in animals and blocks the neurodegenerative effects of amyloid plaques. sAPP alpha is also produced by the platelets and EHT 0202 induces the production of this peptide, which can then be measured in blood. EHT 0202 has already been administered to one hundred young volunteer patients during two Phase I studies in 2005. Over the past months, ExonHit has reached several milestones, which are key to the clinical development of this molecule: identification of the sAPP alpha peptide in blood, pharmaceutical re-formulation of the molecule in order to comply with new European regulations, and, now, Phase Ib studies on elderly healthy patients. Those studies shall be finished in 2007, and after review by the regulatory authorities, EHT 0202 will be tested at different doses in elderly patients with Alzheimer’s disease (Phase 2) while also quantifying the production of sAPP alpha in those patients’ blood.
“The use of a blood diagnostic, which can measure the production of the peptide we believe to be at the origin of the pro-cognitive effects of our molecule, is a good example of clinical research in pharmacogenomics. The FDA and the EMEA encourage therapeutic trials associated with diagnostics that have the potential to better identify those patients who have the best chances of responding positively to the proposed treatment. It is from this perspective that we continue our therapeutic clinical trials, with an international network of clinicians, in order to create the best context possible to licence EHT 0202 after completion of Phase 2 trials.” said Bruno Tocque, Chairman of the Management Board.
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, “SpliceArrays,” 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.
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 the Alternext market of Euronext Paris 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 (www.exonhit.com), that may cause actual results, performance or events to differ materially from those anticipated in the summary information.
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.
Contacts ExonHit Therapeutics Bruno Tocque, C.E.O. Philippe Rousseau, C.F.O. Tel:+33-1-58-05-47-00 philippe.rousseau@exonhit.com
ExonHit Therapeutics SA
CONTACT: Contacts: ExonHit Therapeutics, Bruno Tocque, C.E.O., PhilippeRousseau, C.F.O., Tel:+33-1-58-05-47-00, philippe.rousseau@exonhit.com
