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Enterin completes enrollment in phase 2a study of ENT-01 in patients with Parkinson's disease

Philadelphia, Pennsylvania
Wednesday, March 28, 2018, 10:00 Hrs  [IST]

Enterin Inc., a CNS pharmaceutical company developing novel compounds to treat Parkinson’s disease, autism and schizophrenia, has completed enrollment of a two-stage phase 2a study of ENT-01 in patients with Parkinson's Disease (PD).

The study was conducted at multiple US 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.

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 February 7th edition of the Proceedings of the National Academy of Sciences.

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.


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levi jasper Mar 29, 2018 6:29 AM
My wife was diagnosed at age 64 with Parkinson's disease. she was put on Senemet for 6 months and then Siferol was introduced and replaced the Senemet. During this time span she was also diagnosed with dementia. she started having hallucinations, lost touch with reality. Suspecting it was the medication I took her off the Siferol (with the doctor's knowledge) whcih i started using a natural herbal products. she has improved dramatically.
Rosalyn Gregory Mar 29, 2018 6:02 AM
I was diagnosed five years ago at the age of 51. I had symptoms for 3-4 years prior to that but did not know anything about Parkinson’s. I first noticed a slight twitch in my left hand, finger and thumb, which became pill rolling. We attended a lot of sports events and I would lose my balance in the moving crowd. I then started seeing a neurologist. I started falling a lot when losing my balance and had a hard time walking normal. I finally froze up in the doorway at church. I told my Neuro and he said that I had Parkinson’s. Started me on entacapone,levodopa, carbidopa, and pramipexole and I still didn’t feel or get better January 2017 my neurologist and I decided to go with natural treatment and was introduced to Green House Herbal Clinic natural Parkinson’s disease Herbal formula, i had a total decline of symptoms with this Parkinson’s Herbal formula treatment.
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