AclarusDx can be leveraged for patient selection in clinical trials, and firm is working on IVD applications.
ExonHit Therapeutics has launched AclarusDx™, a blood-based Alzheimer diagnostic for research use only. The test may be used to distinguish Alzheimer patients from those with other forms of dementia for clinical investigations.
AclarusDx is a reproducible, objective, and noninvasive test, according to ExonHit. Trial sponsors will send patients’ blood samples for analysis to the company’s GLP-compliant laboratories in the U.S.
ExonHit is also developing AclarusDx as an in vitro diagnostic with partners. It anticipates receiving a CE mark in the fourth quarter of next year and a European launch in the first quarter of 2011. In the U.S. discussions have been initiated with the FDA to define the regulatory path to meet IVD requirements.
The company is also developing treatments for Alzheimer disease. EHT 206 is in preclinical evaluation, while EHT 0202 is in a Phase II study. EHT 0202 is a GABAA receptor modulator and a PDE4 inhibitor. It stimulates α-secretases, increasing the production of procognitive and neurotrophic sAPPα fragment of the amyloid precursor protein (APP). Results to date suggest that EHT 0202 is able to reduce Aα burden by redirecting APP processing toward the α-secretase pathway, which has favorable effects on neuron viability and cognition.
ExonHit’s diagnostic pipeline comprises tests for breast, colon, and prostate cancer. The latter two diagnostics are being developed with Biomerieux. The firm’s therapeutic pipeline also has an anticancer and an antiepileptic agent in preclinical development. Candidates being investigated with Allergan are further along: EHT/AGN 0001 is a pain and CNS disorder candidate in Phase I testing, and EHT/AGN 0002 is being studied in preclinical models as a treatment for pain, neurodegeneration, and ophthalmologic diseases.