Amydis Awarded $3 Million NIH Grant to Explore Novel Alpha Synuclein Retinal Tracer in Non-human Primate Models of Parkinson’s Disease and Multiple System Atrophy

SAN DIEGO, Oct. 11, 2021 (GLOBE NEWSWIRE) — Amydis Inc., a leading ocular tracer pharmaceutical company with a broad portfolio of diagnostic drug candidates targeting CNS biomarkers in the eye, today announced a grant award of $3 million from the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH). The two-year award will explore the presence of alpha synuclein (ASYN) in the retina of non-human primate models of Parkinson’s Disease (PD) and Multiple System Atrophy (MSA). With the support of two grant awards from the Michael J. Fox Foundation, Amydis has previously shown that its proprietary retinal tracers can detect ASYN in PD mouse models. This NIH grant will also fund Investigational New Drug Application (IND)-enabling studies to support an IND filing with the Food & Drug Administration (FDA). Earlier this year, Amydis completed a pre-IND meeting with the FDA and obtained agreement on the design of a first-in-human Phase 1/2a clinical trial to be conducted in patients and healthy volunteers. The planned Phase 1/2a clinical study will test Amydis’s small-molecule retinal tracer targeting the biomarker ASYN for the diagnosis of synucleinopathies.

Amydis has created an approach to detect ASYN in the retina with its proprietary compounds, designed to be used with commercially available retinal imaging instrumentation that are readily available and routinely used in ophthalmology practice. As such, the Amydis test may provide a simple, affordable, and widely adoptable method for detecting ASYN in patients. Differences in the cellular distribution of ASYN aggregates in PD and MSA may, in principle, result in distinct patterns of the tracer signal, providing an objective biomarker-based test for potential differential diagnosis using an eye examination.

“It is an honor to receive the support of the NIH in our efforts to enable differential diagnosis of PD and MSA through the retina,” stated Stella Sarraf, Ph.D., Chief Executive Officer and Founder of Amydis. “Amydis is focused on exploring the diagnostic utility of a broad spectrum of biomarkers in the retina and we are the first to explore the retina of these non-human primate models for the manifestation of ASYN.”

Amydis will be collaborating with Dr. Jeffrey Kordower, founding director of the Arizona State University-Banner Neurodegenerative Disease Research Center. “There is a clear need to detect the biomarker ASYN to help in the timely diagnosis and treatment of patients,” stated Dr. Kordower. “The differential diagnosis of PD and MSA – from other neurodegenerative conditions and from each other – is challenging and relies heavily on clinical evaluation and imaging modalities that lack specificity. Methods that enable direct, objective, and quantifiable detection of ASYN would also catalyze the clinical development of new disease-modifying therapeutics.”

About Amydis, Inc.

Amydis is developing novel, patent-protected drugs – “retinal tracers”- that enable direct visualization of CNS disease-related molecular changes (biomarkers) in the retina. The Company has a discovery platform and proprietary know-how which uniquely positions it with first mover advantage to explore the retina for a broad spectrum of neurodegenerative diseases that have to date required long-term clinical evaluation and the use of invasive testing for definitive diagnosis. Amydis aims to become a global leader in developing retinal tracers for neurological diseases. The future of effective, sustainable healthcare depends upon knowledge gained through early diagnostics.

Amydis Contact: Ron Newbold, Chief Business Officer, [email protected].