Enterin has completed enrolment in the RASMET study analysing the safety, tolerability and efficacy of ENT-01 in patients with Parkinson's Disease (PD).
The two-stage Phase IIa trial has enrolled a total of 50 patients at multiple sites in the US over a ten-month period.
During the first stage of the trial, single escalating doses of ENT-01 were given to ten patients and titrated to tolerability.
In the second stage, daily escalating doses of ENT-01 were given to 40 patients and titrated to a clinically efficacious or maximum dose, followed by a randomised withdrawal period.
The RASMET study examined the safety, tolerability and efficacy of the orally administered synthetic derivative of squalamine, ENT-01, which is not absorbed into the bloodstream of the patients.
The ENT-01 compound acts locally on the enteric nerve cells of the gut, stimulating gut motility and change afferent neural signalling from gut to brain.
It could be used to improve some or all Parkinson’s Disease symptoms such as constipation, disturbed sleep and hallucinations, as well as modify disease progression.
Enterin noted that synthetic squalamine has recently demonstrated its ability to prevent the buildup and reduce the toxicity of alpha-synuclein, implicated in the pathogenesis and progression of PD.
The compound has also proved its efficiency in displacing alpha-synuclein aggregates from the inner wall of nerve cells, and in preventing the paralysis that develops in C. Elegans worms engineered to produce alpha-synuclein in its muscles.
Enterin is currently in the process of conducting a Phase IIb study for the treatment of patients with PD and constipation in the last quarter of this year.
The company also plans to carry out trial in PD patients with hallucinations, in schizophrenia and in autism in future.