Enterin Inc., a privately held, Philadelphia-based, clinical-stage biopharmaceutical company developing novel treatments for neurodegenerative and metabolic diseases announces a collaboration with the Parkinson's Virtual Biotech, the drug development and discovery arm of Parkinson's UK. A new phase 2 trial will study the effects of ENT-01 on Parkinson's Disease (PD)-associated dementia.
In January 2022, Enterin announced statistically significant results from a randomized, placebo-controlled Phase 2b trial [KARMET] in 150 subjects with PD. In this study, a subset of those enrolled had PD-associated dementia. Patients treated with ENT-01 exhibited improvement in cognitive function compared with those receiving placebo. Statistically significant benefit was observed 6 weeks post treatment suggesting ENT-01 has potential to modify disease progression.
Our studies have demonstrated ENT-01's clinical benefit across a range of PD related non-motor symptoms such as gastrointestinal dysfunction, dementia, psychosis, sleep architecture and circadian rhythm, all commonly associated with PD."
Denise Barbut, Enterin's Co-Founder, President and CMO
The pathologic process in PD dementia (PDD) includes the presence of alpha-synuclein (αS) aggregates in the enteric nervous system (ENS) and central nervous system (CNS). Inhibiting αS aggregation in the ENS may reduce the continuing disease process in both the ENS and CNS and slow the progression of PD. ENT-01 is administered orally and acts locally on the ENS. It dislodges αS aggregates and inhibits their formation, restoring the firing potential of enteric neurons. This effectively improves neural signaling between the gut and brain via the vagus nerve.
"Through the Parkinson's Virtual Biotech, we're very excited to be working with Enterin as they look to develop a potential new treatment for Parkinson's related dementia," said Arthur Roach, Director of Research at Parkinson's UK. "Parkinson's is the fastest growing neurological condition in the world and currently there is no cure. The medications we have today can only treat and manage some of the more than 40 symptoms.
"Whilst Parkinson's is more commonly associated with motor symptoms like tremor, our community has asked us to make new and better treatments for Parkinson's dementia a priority. We are encouraged by the clinical results that Enterin's work has produced to date and look forward to the upcoming clinical trial which will have sites in the UK as well as in America."
"Enterin is very grateful to partner with such a prestigious and well-respected organization," said David McCullough, CEO of Enterin. "We have worked closely with Parkinson's UK and their clinical advisors to design a clinical study to evaluate ENT-01 in PD dementia. It is our hope that we can offer a new therapeutic option for these patients."
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