Amydis Receives $3.4 million NIH Commercialization Readiness Pilot Grant Award to Map Heterogeneity of Alzheimer’s Diseases in Human Clinical Trial Using Novel Retinal Tracer

Amydis Novel Tracer Utilizes an Affordable, Accessible, Non-Invasive Approach as part of a Standard Office Visit

SAN DIEGO, Calif. (November 14, 2023) – Amydis Inc., a privately held clinical-stage company pioneering a platform of ocular tracers to enable imaging of disease biomarkers in the eye, today announced that it has received a two-year Commercialization Readiness Pilot (CRP) Program grant award of $3.4 million from The National Institutes of Health. The grant will fund the use of novel fluorescent tracers to develop a comprehensive retinal biomarker database that maps the heterogeneity of Alzheimer’s pathogenesis.

Alzheimer’s disease, the most common form of dementia, is a mechanistically heterogeneous condition which can involve the accumulation of several molecular biomarkers: amyloid beta, alpha-synuclein, tau and TDP-43. Understanding differences in the manifestation of these biomarkers among Alzheimer’s patients will enable precision treatment empowering physicians with the ability to provide better patient care.

“Our clinical study using a novel retinal tracer is the first step in leveraging the eye as a ‘window to the brain’ to enable the creation of a first-in-class multi-modal database of retinal images for a non-invasive, affordable and widely accessible diagnostic assessment of heterogeneity in the Alzheimer’s spectrum,” said Dr. Stella Sarraf, Amydis founder and chief executive officer. “Approaching Alzheimer’s disease as a heterogenous disorder will likely improve results in the search for effective treatments.”

Amydis is creating a multi-omics data warehouse that will combine the unique molecular biomarkers of the eye with blood biomarkers and genomics to empower AI-enabled precision medicine for the treatment of Alzheimer’s and other neurodegenerative diseases.

Amydis is developing a platform of proprietary small molecule tracers that bind to misfolded protein deposits, including amyloid beta, alpha-synuclein and TDP-43. The company has generated extensive proof-of-concept data from live imaging studies in animal models of Parkinson’s disease, Alzheimer’s and other conditions, as well as postmortem studies using cadaver retinas from Alzheimer’s, Parkinson’s and Amyotrophic Lateral Sclerosis (ALS) patients.

“Despite growing consensus that Alzheimer’s is a mechanistically heterogeneous condition, no diagnostic modalities exist to discern the relative contributions of different pathogenic processes in individual patients. This is a major barrier to progress in developing new therapies and applying current ones with precision in the Alzheimer’s continuum,” Sarraf added. “Our tracer enables the creation of a first-in-class multi-modal retinal image database that includes biomarkers in central nervous system tissue that characterize Alzheimer’s disease. This approach is of the essence for the development of precision therapies by enhancing enrollment and monitoring efficacy relative to multiple disease-relevant biomarkers.”

Research reported in this release was supported by the National Institute On Aging of the National Institutes of Health under Award Number SB1AG050454. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Amydis

Amydis is developing novel, patent-protected molecules, “ocular tracers”, which enable direct visualization of CNS disease-related molecular changes (biomarkers) in the eye.  With this first-in-class capability, Amydis is poised to revolutionize the ability of physicians and researchers to explore the eye for a broad spectrum of diseases, which have to date required long-term clinical evaluation and the use of invasive testing for definitive diagnosis.  The company has a discovery platform and proprietary know-how that positions it as first mover and a global leader in developing ocular tracers for human diseases.  The future of effective, sustainable healthcare depends on knowledge gained through early diagnostics.

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