Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of a First-in-Class Retinal Tracer for the Diagnosis of Alpha-synucleinopathies
San Diego, April 26, 2021 (GLOBE NEWSWIRE) — Amydis Inc., a leading ocular tracer biotechnology company with a broad portfolio of diagnostic candidates for detection of neurodegenerative diseases in the eye, today announced completion of pre-IND (Investigational New Drug) interaction with the U.S. Food and Drug Administration (FDA) regarding the current development plan for a small-molecule retinal tracer for the diagnosis of α-synucleinopathies (ASYN). Funding provided by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) supported the preclinical data for the pre-IND submission. In addition, the pre-IND dossier included information on manufacturing and the design of the proposed Phase 1/2a clinical study.
The FDA was in agreement with the current specifications for the drug substance and with Amydis’ approach regarding the planned definitive toxicology studies to support the IND. Importantly, the FDA was in agreement with the overall design of the proposed adaptive Phase 1/2a first-in-human (FIH) clinical study in Parkinson’s Disease (PD) patients. The design of the study may allow for an early read-out on the potential ability of the retinal tracer to diagnose patients with ASYN.
“We appreciate the FDA’s clear guidance on the path to introduce our novel ocular tracers to address an unmet need in PD,” said Stella Sarraf PhD, Founder and Chief Executive Officer of Amydis. “Our technology offers the potential for the routine diagnosis of Parkinson’s in a community practice setting, and may have important advantages for the detection, treatment, and epidemiological surveillance of synucleinopathies. We look forward to advancing this novel tracer into the clinic.”
Visual symptoms are prevalent in PD patients and often start in the prodromal stage preceding cardinal PD tremor and progressing with disease. The Amydis technology may enable the detection of ASYN years before PD symptoms are apparent. The ability to begin clinical data collection on PD patients allows Amydis to accelerate its activities in disease detection, differentiation, and monitoring.
“Objective measures of synucleinopathy would speed development of new therapies for the millions of people with these conditions,” said Samantha Hutten, Ph.D., Director of Research Programs at MJFF. “The Amydis technology may enable researchers to enroll the right participants in trials and to understand if their therapy is having the intended effect. These advantages lead to smaller, faster trials.”
About Amydis, Inc.
Amydis is developing novel, patent-protected small molecule ocular tracers, which enable direct visualization of CNS disease-related molecular changes (biomarkers) in the eye. The Company’s discovery platform and proprietary know-how uniquely positions it with first mover advantage to explore the eye for a broad spectrum of neurodegenerative diseases, which have historically required long-term clinical evaluation and the use of invasive testing for definitive diagnosis. Amydis aims to become a global leader in developing ocular tracers for degenerative and systemic diseases. For more information on the Company, please visit www.amydis.com
Amydis Contact: Ron Newbold, Chief Business Officer, email@example.com