Targeting the underlying disease
Researchers noted that, in small subsets of patients with dementia or psychosis, greater improvements in those symptoms occurred among those who took ENT-01 versus those who took a placebo.
According to the study, among 11 patients with psychosis, average scores on the Scale for the Assessment of Positive Symptoms adapted for PD dropped from 6.5 to 1.8 on a 45-point scale at the end of treatment in the ENT-01 group (n = 5) and from 6.3 to 3.4 in the placebo group (n = 6).
In 28 patients with dementia, scores on the Mini-Mental State Examination improved by 2.4 points on a 30-point scale, from 24.1 to 26.5, during the treatment period for the ENT-01 group (n = 14) versus an improvement of 0.9 points, from 24.8 to 25.7, in the placebo group (n = 14).
The researchers said the findings must be evaluated in future trials dedicated to studying ENT-01’s effects on PD-related psychosis and dementia.
Dr. Satish Rao
He added that, if findings are reproduced in a large study, the drug could have “a major impact” not just in treating constipation, for which there are no PD-specific drugs, but also in addressing neurological dysfunctions that are cardinal features of PD. “That is what is exciting to me, because we’re now talking about reversing the disease itself,” he said.
However, Dr. Barbut said it’s been difficult to get across to the medical community and to investors that a drug that acts on nerve cells in the gut might reverse neurologic symptoms by improving direct gut-brain communication. “That’s a concept that is alien to most people’s thinking,” she said.
Enterin funded the study and was responsible for the design, data collection and analysis. Its employees also participated in the interpretation of data, writing of the report, and the decision to submit the manuscript for publication. Dr. Barbut reported stock options in Enterin and patent interests in ENT-01. Fifteen other study investigators reported financial ties to Enterin and/or ENT-01 including employment, stock options, research funding, consulting fees and patent application ownership. Dr. Rao reported receiving honoraria from multiple companies that market drugs for general constipation.