Pharmaceutical company Enterin Inc reported on Wednesday that start of enrolment of patients under the KARMET study to evaluate safety, tolerability and efficacy of orally administered ENT-01 for the treatment of Parkinson's disease.
In conjunction with the KARMET study, Dr Goldstein of Atlantis, Florida and Dr Kadimi of Fairfield, Connecticut, have both enrolled.
The KARMET study is a Phase 2b multi-centre, randomised, double-blind, placebo-controlled, multiple-dose study to evaluate safety, tolerability and efficacy of orally administered ENT-01 for the treatment of Parkinson's disease. This clinical trial will enrol 72 patients over a six-month period.
Additionally, the KARMET study is a follow-up to a successful Phase 2a RASMET study completed last year.
According to the company, ENT-01 is an orally administered, synthetic derivative of squalamine that acts locally on the enteric nerve cells of the gut, stimulating gut motility and altering afferent neural signalling from gut to brain. It has the potential to ameliorate some or all of the non-motor and motor symptoms of Parkinson's disease, including constipation, motor dysfunction, hallucinations, memory, depression, fragmented sleep and REM-behaviour disorder.
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