Enterin Inc., a privately-held CNS pharmaceutical company based in Philadelphia and developing novel compounds to treat Parkinson’s disease (PD), has enrolled the first patient in the RASMET study. The study is a Phase 1/2a randomized, controlled, multicenter study involving patients with PD and taking place at 12 US sites. It will enroll 50 patients over a 9-to-12-month period. The first stage is open label and involves single escalating doses in 10 patients with PD. Participating sites include Denver, Boca Raton, Tampa Bay and Cleveland. Details relating to the study can be found at ClinicalTrials.gov, and contact information is available on the Enterin website.
The study will establish the safety, tolerability and efficacy of an orally administered synthetic derivative of squalamine, which is not absorbed into the blood stream. The compound acts locally on the enteric nerve cells of the gut, stimulating gut motility and altering afferent neural signaling from gut to brain. It has the potential to ameliorate some or all of the non-motor symptoms of Parkinson’s disease, including constipation, fragmented sleep and REM-behavior disorder, and 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 their 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 in the world 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 (also known as kenterin), 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. In the gut, this results in improved motility. Enterin Inc. is now progressing ENT-01 through clinical trials in an attempt to reverse the constipation of Parkinson’s disease. For more information, please visit www.enterininc.com.