Cognoptix Drug/Device Test Identifies Alzheimer’s Disease via Beta Amyloid Signature in the Eyes in a 10-Subject Proof-of-Concept Clinical Trial

Detecting specific fluorescent signature of ligand-marked beta amyloid in supranucleus region of the human lens achieves two-fold differentiation factor between controls and AD patients

“Cognoptix has developed a combination drug/device system, SAPPHIRE II, into a simple eye test that will change the way Alzheimer’s is detected and managed, and we are the only company positioned to make this happen soon.”

Paul Hartung, President and CEO, Cognoptix

ACTON, Mass.--(BUSINESS WIRE)--Cognoptix, an emerging medical device company announced today that its SAPPHIRE II eye test identified Alzheimer’s disease patients via a beta amyloid (“Ab”) signature in their eyes in a 10-subject proof-of-concept clinical trial. By detecting a specific fluorescent signature of ligand-marked beta-amyloid in the supranucleus region of the human lens, SAPPHIRE II achieved a two-fold differentiation factor between a group of five healthy volunteers and a group of five patients diagnosed with probable Alzheimer’s disease.

“Positron Emission Tomography (PET) imaging has been recently approved to enable detection of beta amyloid neuritic plaques in living AD patients. However, there is a clear need for a low cost, non-invasive technology capable of improving the differential diagnosis of dementia which is practical for widespread use at point-of-care.”

Cognoptix has exclusively licensed groundbreaking technology from the University of California at San Diego (“UC San Diego”), which Cognoptix has developed into an innovative, non-invasive eye-scanning test, SAPPHIRE II, for the early detection and diagnosis of Alzheimer’s disease (“AD”) pathology. The UC San Diego technology is the subject of a scientific paper recently published in the peer-reviewed Journal of the American Chemical Society (“Aminonaphthalene 2-Cyanoacrylate [ANCA] Probes Fluorescently Discriminate between Amyloid-β and Prion Plaques in Brain”).

“Presently, there is a major effort investigating the role of beta amyloid neuritic plaques in the brains of adult patients with cognitive impairment and possible Alzheimer’s disease,” said Carl Sadowsky, M.D., F.A.A.N., Medical Director at Premiere Research Institute in West Palm Beach Fla., and a principal investigator in the SAPPHIRE clinical study. “Positron Emission Tomography (PET) imaging has been recently approved to enable detection of beta amyloid neuritic plaques in living AD patients. However, there is a clear need for a low cost, non-invasive technology capable of improving the differential diagnosis of dementia which is practical for widespread use at point-of-care.”

“Currently there is no early-stage non-invasive diagnostic for Alzheimer’s disease in the market,” added Paul Hartung, President and CEO of Cognoptix. “Unfortunately, patients often incur up to 50% neuronal loss and a delay of up to two years before demonstrating severe enough symptoms to achieve diagnosis by the current gold standard: a ‘process of elimination’ of other possible diagnoses such as stroke, trauma, Parkinson’s disease, dementia, etc., through extensive cognitive and physical testing. New therapeutic drugs to slow or stop the progress of AD are expected to reach the market soon. Cognoptix is developing a method of early-stage diagnosis to allow treatment before significant neuronal loss and irreversible brain damage occurs.”

The Cognoptix SAPPHIRE II system consists of a laser-based reading device and consumable ophthalmic ointment. The eye exam can be given by a general practitioner and only takes a few minutes to achieve a result. The Cognoptix drug/device combination is an entirely novel, early-stage diagnostic for Alzheimer’s disease designed to allow treatment before significant neuronal loss and irreversible brain damage occurs. Cognoptix has a strong and comprehensive patent portfolio covering diagnosis of beta amyloid-based diseases via ophthalmic imaging. The patent portfolio includes issued “method” and “device” patents, as well as pending “composition of matter” patents. In addition to UC San Diego, exclusive licenses have been acquired from Massachusetts General Hospital and Brigham and Women’s Hospital Boston.

Five (5) AD subjects (2 females, 3 males) ranging from 65 to 83 years old met the accepted standards for Probable Alzheimer’s Disease, including an MRI brain scan ruling out stroke and/or generalized cerebrovascular disease. Control subjects (5 males) ages 31 to 77 years old had no evidence of cognitive impairment, and had an MRI brain scan that was judged as “normal” (age appropriate).

There are more than 100 new Alzheimer’s drugs that are in various stages of research and development. The ability of the Cognoptix drug/device combination to easily identify and qualify patients for clinical study inclusion, as well as accurately and inexpensively track patient disease progression, may provide pharmaceutical companies with a significant competitive advantage in securing new Alzheimer’s drug approvals. It may also help identify and document differentiating pharmaceutical product performance attributes in Phase 4 studies.

About SAPPHIRE II

Cognoptix has developed an in-office, drug/device diagnostic system designed as an aid in the early detection of Alzheimer’s Disease (AD) pathology. A ligand or contrast agent (drug) and software-controlled optical instrument (device) allows for noninvasive detection and assessment of AD by measuring the hallmark of AD, beta amyloid, in the supranuclear region of the lens of the eye. The ligand is easily administered to the eye as an ophthalmic ointment and a proprietary Fluorescent Ligand Scanning (FLS) instrument, provides an objective and quantitative measurement of beta amyloid in the patient’s lens. Significantly faster and an order of magnitude less expensive than brain imaging, the test and diagnosis can be quickly completed in any physician’s office, including general practitioners. The technology is currently in clinical trials.

About Cognoptix

Cognoptix, a privately held medical technology company headquartered in Acton, Mass., is focused on developing and commercializing an in-office, drug/device diagnostic system as an aid in the early detection of Alzheimer’s Disease (AD). Its investors include Inventages Venture Capital, one of the world’s largest life sciences-, nutrition- and wellness-focused venture capital firms; and Launchpad Venture Group, a Boston-based angel investment firm that provides funding to early-stage companies.

NOTE: The SAPPHIRE II system is approved for investigational use only in the United States.