NeuroTherapia, Inc. conducted a 28-day double-blind, randomized phase 2a trial of its oral candidate NTRX-07 in patients with Alzheimer’s disease.
The trial enrolled 48 subjects in a 1:1 randomized design at five sites in Hungary, Poland and the Czech Republic and was administered by CRO CRU Global. The study met its primary objective of safety and tolerability, with overall adverse events similar between the treatment and placebo groups, and no serious treatment-related adverse events reported in the active arm. The protocol includes pharmacokinetic and clinical evaluations (ADAS-Cog, MMSE and Trail Making Test) and is designed to assess target engagement using biomarkers of neuroinflammation and neuronal function.
Preliminary analyzes of exploratory endpoints, including MRI, qEEG, and CSF biomarkers, were described as encouraging, with MRI findings tending to moderate active treatment.
NeuroTherapia is partnering with Oxford Brain Diagnostics Ltd to further analyze the mri data using the CDM Explore platform. The company claims that preclinical studies have shown microglial regeneration, reduced brain Aß and improved cognition in animal models; The trial was partially funded by the Alzheimer’s Association.
