Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy

SAN DIEGO, Jan. 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 successful completion of pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for its lead candidate, AMDX-2011P, a small-molecule retinal tracer that targets amyloid beta for the diagnosis of amyloid angiopathy. Amydis has reached agreement with the FDA on both nonclinical and clinical plans. The FDA also supports Amydis’ adaptive Phase 1/2a first-in-human (FIH) clinical development plans for evaluating AMDX-2011P as a potential retinal tracer to diagnose patients with cerebral amyloid angiopathy (CAA), an age-associated disease in which amyloid proteins build up on the walls of the arteries in the brain increasing the risk for stoke caused by bleeding and dementia.

“This feedback from the FDA is a significant milestone for Amydis,” said Stella Sarraf PhD, Founder and Chief Executive Officer of Amydis, “We are pleased to have reached agreement with the FDA on our clinical plan for AMDX-2011P in CAA patients and we appreciate the FDA’s guidance on our path to introduce this new class of ocular tracers.”

CAA is a major cause of spontaneous intracerebral hemorrhage in people older than 55 and an important contributor to age-related cognitive decline. Current diagnosis of CAA involves expensive imaging tests (MRI, CT scans, and PET amyloid tests) yet physicians are unable to confidently diagnose CAA without a sample of brain tissue. The Amydis technology is designed to provide an affordable and accessible retinal test as a welcome addition to the armamentarium of diagnostic tests available to physicians.

Steven M. Greenberg M.D., Ph.D., Professor of Neurology at Harvard Medical School & Director of the Hemorrhagic Stroke Research Program at Massachusetts General Hospital and a leading CAA authority who is unaffiliated with Amydis said, “I am excited to collaborate with Amydis on the FIH clinical trials. I am keenly aware of the challenges CAA patients face in the diagnosis and treatment of disease. I believe that diagnosis of CAA through the eye would be a tremendous step forward for the field.”

About Amydis, Inc.

Amydis is a hybrid biotechnology company developing a new class of diagnostics, which enable the eye to serve as a window to the brain to accelerate the early detection of neurological, ocular, and systemic diseases, accelerate and improve the clinical evaluation of novel therapeutics, and revolutionize treatment. Amydis uses novel small molecule contrast agents – “ocular tracers” – which bind selectively to disease-related amyloid proteins (e.g. amyloid beta, alpha synuclein, prion, Tau, etc) and emit a strong fluorescent signal upon binding which can be imaged with existing cameras in clinical practice. This enables direct visualization of disease-related biomarkers in the retina, which Amydis has confirmed in multiple NIH and Michael J Fox funded animal model studies of Alzheimer's Disease, Parkinson’s Disease, cerebral amyloid angiopathy, traumatic brain injury, and Creutzfeldt-Jacob disease.  For more information on the Company, please visit www.amydis.com.

Amydis Contact: Ron Newbold, Chief Business Officer, ron@amydis.com.


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