Enterin has identified a series of small compounds originating in the dogfish shark, which can prevent alpha synuclein (αS) – the culprit in Parkinson’s Disease (PD) – from accumulating within the nerves of the gastrointestinal (GI) tract. Our lead compound is called kenterin (ENT-01). Alpha synuclein will stick tightly to certain types of membranes, especially those that line the inside of nerve cells. Membrane bound molecules of αS 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 remarkable property of entering the nerve cell, attaching itself to the nerve’s membrane, and dislodging αS. If αS can’t bind to a membrane, it can’t form aggregates. It’s that simple. There are no other known drugs on market or in development that act via this mechanism of action. We have shown success in two preclinical animal models of Parkinson’s Disease and will be conducting a Phase 1/2a study in the near future.
We are taking ENT-01 (kenterin) into human clinical trials for the treatment of constipation associated with PD. ENT-01 will be an oral capsule or tablet, since its site of action will be topically in the gut. After a successful pre-IND meeting with the FDA in mid-2016, we are moving forward with a Phase I/IIa multi-center, randomized controlled clinical trial to evaluate the safety, tolerability and efficacy of ENT-01. The study will aim to assess approximately 50 PD patients with constipation. Additional clinical trials will follow thereafter.
We will assess ENT-01’s ability to deliver the following outcome in those with Parkinson’s Disease:
- Correction of constipation
We will also be exploring ENT-01’s ability to deliver the following outcomes:
- Improvement in sleep architecture
- Improvement in temperature regulation
- Improvement in mood, with reduced depression and anxiety
- Improvement in cognition
- Improvement in nocturnal visions/delusions/hallucinations