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Amydis announced the successful completion of a pre-investigational new drug (IND) meeting with the FDA for its candidate AMDX-2011P, a small-molecule retinal tracer that targets amyloid beta to diagnosis amyloid angiopathy.
Amydis announced today the successful completion of a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for its candidate AMDX-2011P, a small-molecule retinal tracer that targets amyloid beta to diagnosis amyloid angiopathy.
According to a company news release, Amydis has reached an agreement with the FDA for both nonclinical and clinical plans.
Additionally, the company reported that the FDA supports its 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).
“This feedback from the FDA is a significant milestone for Amydis,” said Stella Sarraf, PhD, founder and CEO of Amydis, in the release. “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.”
A major cause of spontaneous intracerebral hemorrhage in patients age 55 and up, CAA is a major contributor to age-related cognitive decline.
Current technology for CAA diagnoses includes imaging testing and requires physicians to acquire a brain tissue sample. In comparison, Amydis’s retinal tracer is designed to provide accessible and affordable retinal testing for patients.