Date: 2017-02-03
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Enterin (USA - PA)
Product: ENT-01 (kenterin)
Action
mechanism: alpha synuclein inhibitor. Kenterin is a small compound originating in the dogfish shark, which can prevent alpha synuclein (?S) – the culprit in Parkinson’s disease – from accumulating within the nerves of the gastrointestinal tract. Alpha synuclein will stick tightly to certain types of membranes, especially those that line the inside of nerve cells. Membrane bound molecules of ?S have a tendency to clump together, much more so than when they are freely floating within a cell. It is these ‘clumps’ or aggregates that damage the nerve cell; they are also called ‘Lewy Bodies’ after the scientist who first recognized them. Kenterin has the property of entering the nerve cell, attaching itself to the nerve’s membrane, and dislodging ?S.
Disease: constipation associated with Parkinson's Disease
Therapeutic area: Neurodegenerative diseases
Country: USA
Trial
details: RASMET is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally-administered ENT-01 to relieve symptoms of constipation associated with Parkinson's Disease. Ten patients will be enrolled in Phase 1, and will be studied over an 8-12 week period. Forty patients will be enrolled in Phase 2, and will be studied over an 8-10 week period. All subjects will receive the study drug during one of the observational periods of the study. (NCT03047629)
Latest
news: * On February 3, 2017, a Phase 1-2 trial sponsored by Enterin was published on the NIH website ClinicalTrials.gov for ENT-01. The study will begin in March 2017, and will be conducted at sites in New York, New Brunswick, Philadelphia, Cleveland, Tampa, Sarasota, Boca Raton, Denver, Los Angeles, Kansas. Fifty patients with Parkinson’s disease and constipation will be included.
