PHILADELPHIA, March 26, 2018 /PRNewswire/ -- Enterin Inc., a CNS pharmaceutical company based in Philadelphia and developing novel compounds to treat Parkinson's disease (PD), autism and schizophrenia, has completed enrollment of a two-stage Phase 2a study of ENT-01 in patients with PD. The study was conducted at multiple U.S. sites and 50 patients were enrolled over a 10-month period. In the first stage, single escalating doses of ENT-01 were administered to 10 patients and titrated to tolerability. In stage 2, daily escalating doses were administered to 40 patients and titrated to a clinically efficacious or maximum dose, followed by a randomized withdrawal period. Participating sites included Tampa Bay, Sarasota, Boca Raton, Port Charlotte, Georgetown, Los Angeles, New York, Philadelphia, Cleveland, Detroit, Michigan, Denver and others. Details relating to the study can be found at ClinicalTrials.gov and on Enterin's website, www.enterininc.com.
The study evaluated the safety, tolerability and efficacy of an orally administered synthetic derivative of squalamine (ENT-01), 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. It has the potential to ameliorate some or all symptoms of Parkinson's disease, including constipation, disturbed sleep and hallucinations, 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 paralysis that develops in C. Elegans worms engineered to produce alpha-synuclein in its muscles. The results were published online in the Feb. 7 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.
Enterin is planning to conduct a Phase 2b study in patients with PD and constipation in Q4 2018. Sites interested in participating should apply through Enterin's website. The company is also planning to conduct studies in PD patients with hallucinations, in schizophrenia and in autism.
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 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 enteric nervous system and improves neural signaling between the gut and the brain in preclinical models of Parkinson's disease. In the gut, this results in improved mobility. Enterin Inc. is now progressing ENT-01 through clinical trials aimed at reversing the constipation of Parkinson's disease. For more information, please visit www.enterininc.com.