Amydis has commenced enrolment of cerebral amyloid angiopathy (CAA) patients in the Phase I/IIa trial of AMDX-2011P.
The open label, randomised, blinded endpoint assessment trial has been designed to assess the pharmacokinetics, tolerability, activity, and safety of escalating intravenous (IV) doses of AMDX-2011P in CAA patients.
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In the trial, participants will receive different amounts of the investigational retinal tracer for determining the safest dose.
It is backed in part by a $3m commercialisation readiness pilot grant from the National Institute of Aging at the National Institutes of Health (NIH).
The Phase I/IIa section is part of a larger ‘basket trial’, which also includes a trial assessing Amydis’ AMDX-2011P investigational retinal tracer in patients with amyotrophic later sclerosis (ALS) and Parkinson’s disease.
The trial will assess AMDX-2011P’s ability to identify the protein TDP-43 in the retina of ALS patients and to identify α-syn in the retina of Parkinson’s disease patients.
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By GlobalDataThese trials are being conducted at two sites located in Southern California.
Amydis CEO and founder Dr. Stella Sarraf said: “We are thrilled to expand our basket trial to enrol patients with CAA.
“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.”
AMDX-2011P is a small molecule ocular imaging agent targeting deposits of Aβ in the retina of CAA patients.
According to the company, CAA occurs in approximately 48% in people with Alzheimer’s disease due to overlapping etiology and develops in up to 23% of the general ageing population.
