ExonHit Therapeutics (Paris:ALEHT) is pleased to announce that AclarusDx™ Alzheimer’s test (formerly known as EHT Dx21), its blood-based test for the detection of Alzheimer’s disease (AD), is now available as a Research Use Only (RUO) product for pharmaceutical companies and leading academic centers conducting clinical trials in Alzheimer’s disease.
“Alzheimer’s disease is a multi-factorial and a complex pathology. Currently, its diagnosis is mainly based on clinical criteria, i.e., relies on subjective measurements. Including subjects who are not properly characterized may easily increase the cost of a clinical study and potentially jeopardize its success,” commented Loïc Maurel, M.D., President of the Management Board of ExonHit Therapeutics. “The use of AclarusDx™ Alzheimer’s test could be a tremendous asset for the pharmaceutical industry as it has the potential to identify populations of patients who might benefit the most from therapeutic advances in AD.”
AclarusDx™ Alzheimer’s test is a reproducible, objective, and non invasive test. A blood sample is all that is required from the patient, so it can be implemented at any recruiting site. Unlike brain imaging techniques or cerebrospinal fluid sampling, no special equipment or medical facilities are required and the ease of the procedure should enhance volunteers’ willingness to participate in trials. It may also increase the recruitment speed and allow the clinical trial sponsor to include investigating centers other than the main hospitals. When used in combination with neuro-cognitive tests, AclarusDx™ Alzheimer’s test could help pharmaceutical companies running clinical trials to include patients fulfilling clinical criteria for AD and who share a common transcriptional profile that has been correlated to AD. Hence, AclarusDx™ Alzheimer’s test could lower the trial’s “background noise” and potentially lead to a better study outcome by selecting a more homogeneous study population.
In 2008, 43 clinical trials involving approximately 10,700 patients were initiated to test new AD therapies. In 2009, 70 AD clinical studies involving around 14,000 patients were started .To recruit one Alzheimer patient, 3 to 4 individuals have to be screened.
The launch of AclarusDx™ Alzheimer’s test as a RUO product is the first step in ExonHit’s commercial strategy in which trial sponsors will send patient blood samples for analysis in ExonHit’s GLP-compliant laboratories in the US. In parallel, the Company is preparing the launch of its product in the clinical in vitro diagnostics (IVD) market with partners. ExonHit is anticipating a CE marking in Q4 2010 for a European launch in Q1 of 2011. Regarding US marketing approval, discussions have been initiated with the FDA to define the exact regulatory path to meet IVD requirements.
ExonHit Therapeutics has a unique approach to Alzheimer’s disease with both therapeutic (EHT 0202, its lead candidate in Phase II) and diagnostic programs (AclarusDx™ Alzheimer’s test) in clinical development. For its research and development work in AD diagnostics and more recently therapeutics, ExonHit is counseled by experts from both sides of the Atlantic: Jeffrey Cummings, M.D., Serge Gauthier, M.D., Zaven Khachaturian, Ph.D., Peter Snyder, Ph.D. and Bruno Vellas, M.D..