The first participant is enrolled in a clinical study of ENT-01(Enterin, Philadelphia, PA), a compound designed to reverse neurologic symptoms associated with Parkinson’s disease dementia (PDD). The aim of the DEMET study, an open-label multi-center trial, is to enroll 30 participants with PDD over a 6-month period. Participants will receive escalating daily doses of ENT-01, followed by a fixed dose for 25 days.
ENT-01 is a synthetic derivative of squalamine that is not absorbed into the bloodstream. Synthetic squalamine has been shown to prevent buildup and reduce toxicity of alpha-synuclein , which is implicated in the pathogenesis and progression of Parkinson's disease.
Designed to displace membrane-bound, alpha-synuclein aggregates from neurons of the enteric nervous system, it is hoped that ENT-01 may improve neural signaling between the gut and the brain, stimulate gut motility, and alter afferent neural signaling from gut to brain.
In the phase 2a RASMET study (NCT03047629), ENT-01 improved both motor and non-motor symptoms of Parkinson’s disease and showed potential to modify disease progression.