Results of phase 2b study published:Improved constipation & psychosis. Oral ENT-01 Targets Enteric Neurons to Treat Constipation in PD.

acpjournals.org/doi/10.7326...

Interesting - the results of the KARMET study have been published by the biotech firm Enterin; This was a randomized, placebo-controlled Nhase 2b study (N=150; NCT03781791); 25 days treatment with ENT-01 was safe, improved constipation & psychosis

Results:

The weekly CSBM rate increased from 0.7 to 3.2 in the ENT-01 group versus 0.7 to 1.2 in the placebo group (P < 0.001). Improvement in secondary end points included SBMs (P = 0.002), stool consistency (P < 0.001), ease of passage (P = 0.006), and laxative use (P = 0.041). In patients with dementia, MMSE scores improved by 3.4 points 6 weeks after treatment in the ENT-01 group (n = 14) versus 2.0 points in the placebo group (n = 14). Among patients with psychosis, SAPS-PD scores improved from 6.5 to 1.7 six weeks after treatment in the ENT-01 group (n = 5) and from 6.3 to 4.4 in the placebo group (n = 6). ENT-01 was well tolerated, with no deaths or drug-related serious adverse events. Adverse events were predominantly gastrointestinal, including nausea (34.4% [ENT-01] vs. 5.3% [placebo]; P < 0.001) and diarrhea (19.4% [ENT-01] vs. 5.3% [placebo]; P = 0.016).

[LeharLover62]

Interesting! Provides more and more evidence to the gut-brain theory.

[jeffreyn]

See also this comment from Michael Okun.

" ... we should not necessarily attribute the effects of this drug on constipation to a potential α-synuclein–related mechanism. The mechanism of ENT-01's effects in animal models supported primary neuronal stimulation, and the immediate effects on cognition and psychosis were unlikely due to altering α-synuclein."

jwatch.org/na55500/2022/11/...