Amydis Announces Enrollment of Cerebral Amyloid Angiopathy Participants in Phase 1/2a Retinal Tracer Trial
February 21, 2023 (GLOBE NEWSWIRE) – Amydis Inc., a privately held clinical-stage company pioneering a platform of ocular tracers that enable imaging of disease biomarkers in the eye, today announced initiation of enrollment of patients with cerebral amyloid angiopathy (CAA), an age-associated disease in which a protein called amyloid beta (Aβ) builds up on the walls of the arteries in the brain increasing the risk for stroke and dementia. CAA develops in up to 23% of the general population with aging, and it occurs at a higher rate of ~48% in people with Alzheimer’s disease due to overlapping etiology. The Randomized Open, Blinded Endpoint Phase 1/2a trial funded in part by a $3 million commercialization readiness pilot grant from the National Institute of Aging at National Institutes of Health (NIH) is evaluating the safety, tolerability, pharmacokinetics, and activity of AMDX-2011P, a proprietary small molecule ocular imaging agent targeting deposits of Aβ in the retina of patients with CAA. This trial (NCT05709314) is part of a larger “basket trial” that also includes a study (NCT05542576) evaluating Amydis ocular tracer technology in amyotrophic later sclerosis and Parkinson’s disease. These studies are being conducted at two sites in Southern California. Additional information regarding the clinical trial, may be found at https://probeclinicaltrial.com/home.
Even with current expensive imaging tests such as MRI, CT scans, and PET amyloid tests, physicians are not able to confidently diagnose CAA without a sample of brain tissue. The Amydis retinal tracer is designed to be used with conventional ocular imaging cameras already in clinical practice and provides the potential to be able to quantify the presence of vascular deposits of Aβ directly in a central nervous system (CNS) tissue, the retina, at micron-level resolution. The Amydis test is positioned as a more affordable and accessible test available to physicians
“We are thrilled to expand our basket trial to enroll patients with CAA,” said Dr. Stella Sarraf, Chief Executive Officer and Founder of Amydis. “Our mission in developing the Amydis ocular tracer for CAA is to enable physicians to take better care of patients by facilitating earlier intervention and avoiding prescription of medications contraindicated in this disease, thereby decreasing the likelihood of their patients having a hemorrhagic stroke.”
About Amydis, Inc.
Amydis is developing novel, patent-protected molecules – “ocular tracers”- that enable direct visualization of CNS disease-related molecular changes (biomarkers) in the eye. With this first- in-class capability, Amydis is poised to revolutionize the ability of physicians and researchers to explore the eye for a broad spectrum of diseases that have to date required long-term clinical evaluation and the use of invasive testing for definitive diagnosis. The company has a discovery platform and proprietary know-how that position it as first mover and a global leader in developing ocular tracers for human diseases. The future of effective, sustainable healthcare depends on knowledge gained through early diagnostics. Amydis Contact: Jack Thrift, Chief Financial Officer, firstname.lastname@example.org