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Navidea Biopharmaceuticals Announces Positive Initial Results In Single-Center Cohort From Phase 2b Trial Of NAV4694 In Subjects With Mild Cognitive Impairment (MCI)

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that the Company’s investigational beta-amyloid imaging agent, NAV4694, produced highly differentiated images in the first cohort of subjects enrolled in the Company’s Phase 2b positron emission tomography (PET) imaging study of subjects with Mild Cognitive Impairment (MCI). The subjects were enrolled and evaluated at the Alzheimer's Disease Center at Quincy Medical Center, Quincy, MA. The results indicate that NAV4694 produced high-quality diagnostic images that segregated MCI subjects into two discrete groups, either amyloid-positive or amyloid-negative.

The image evaluation was performed on twelve subjects meeting pre-defined inclusion/exclusion criteria for emerging, or early-stage, cognitive impairment. NAV4694 scans were assessed by two independent readers using a 3-point visual scale. Image interpretation used the Company’s proprietary visual-read algorithm. All twelve MCI subjects segregated into either amyloid-positive or amyloid-negative categories. The technical quality of the scans was good and both raters were in complete agreement on the 3-point scale, with 8 scans highly positive for β-amyloid and 4 scans negative. There were no intermediate ratings or ambiguous cases despite the early-stage characterization of the subjects’ cognitive impairment status. The scans were easy to read and the readers noted that the high gray matter relative to white matter signal made image interpretation very straight forward. To date, the product candidate appears to be safe and well-tolerated. Results are expected to be presented at an upcoming scientific conference on Alzheimer’s disease (AD).

“We are very pleased with the diagnostic image quality of NAV4694 in patients with mild cognitive impairment, offering the potential to identify individuals who are at high risk of developing dementia caused by AD before their symptoms become severe,” said Dr. Anil K. Nair, MD, Chief of Neurology and Head of the Alzheimer's Disease Center at Quincy Medical Center. “These patients are routinely the most difficult to diagnose. The images generated using NAV4694 are easy to interpret and have resulted in the segregation of early-stage patients into two discrete categories: those with positive scans versus those with negative scans. We are encouraged at the potential to separate patients with emerging disease, enabling earlier and more accurate differentiation of MCI subjects who are at risk of developing AD from those who are not and before the disease has advanced to the stage of impairing daily activities. If AD could be diagnosed at an earlier stage, before clinical dementia has fully developed, the potential for successful intervention with current and future treatments could be improved considerably.”

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