Enterin's DEMET Study Enrolls First Patient With Parkinson's Disease Dementia (PDD)
PHILADELPHIA, June 24, 2019 (Newswire.com) - Enterin Inc., a CNS pharmaceutical company based in Philadelphia and developing novel compounds to treat Parkinson’s disease (PD), has enrolled the first patient in the DEMET study. The study is an open label multi-center study involving patients with PDD and taking place at 15 US sites. It will enroll 30 patients over a 6-month period. The study design is similar to the Phase 2B (KARMET) study, which involved patients with PD and constipation. The KARMET study recently completed enrollment. In the DEMET study, patients with PDD will be given escalating daily doses of ENT-01, followed by a fixed dose period for a total of 25 days. Inclusion criteria include a MoCA score of 23 or less. Participating sites include Georgetown University, University of Southern Florida and Penn State University. Details relating to the study and to participating sites can be found at ClinicalTrials.gov. and contact information is available on Enterin’s website, www.enterininc.com.
The study will establish the safety, tolerability and efficacy of orally administered ENT-01, a synthetic derivative of squalamine which is not absorbed into the bloodstream. The compound acts locally on the enteric nerve cells of the gut, stimulating gut motility and altering afferent neural signaling from gut to brain. In a Phase 2a (RASMET) study, ENT-01 improved both motor and non-motor symptoms (article accepted for publication) and has the potential to modify disease progression.
Synthetic squalamine was recently shown to prevent the buildup and reduce the toxicity of alpha-synuclein, implicated in the pathogenesis and progression of Parkinson’s disease. The compound was shown to displace alpha-synuclein aggregates from the inner wall of nerve cells, and to prevent the stiffness which develops in C. Elegans worms engineered to produce alpha-synuclein in its muscles. The results were published online in the February 7th edition of the Proceedings of the National Academy of Sciences (Perni et al, PNAS Vol 114, no 6, 2017, doi: 10.1073/pnas.1610586114). Links to the article and to the press coverage can be found at the Enterin website.
About Enterin Inc.
Enterin Inc. is the first company to develop a novel drug that repairs the dysfunctional gut-brain axis in patients with neurodegenerative disease. Enterin Inc. is pioneering the medical community’s understanding of the link between infections, dysfunction of the enteric nervous system (ENS) of the gut and the early onset and chronic progression of neurodegenerative disease. The lead compound, ENT-01, displaces membrane-bound alpha-synuclein (αS) aggregates from nerve cells in the ENS and improves neural signaling between the gut and the brain in preclinical models of Parkinson’s disease. Enterin Inc. is now progressing ENT-01 through clinical trials in an attempt to reverse the constipation and neurologic symptoms of Parkinson’s disease.
For more information, please visit www.enterininc.com.
Source: Enterin Inc.