Amydis 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.
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“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. 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.