NeuroTherapia, Inc. completed a 28-day, double-masked, 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 across five sites in Hungary, Poland and the Czech Republic and was managed by CRO CRU Global. The study met its primary objective of safety and tolerability, with overall adverse events similar between treatment and placebo groups and no treatment-related serious adverse events reported in the active arm. The protocol included pharmacokinetic and clinical assessments (ADAS-Cog, MMSE and Trail Making Test) and was designed to assess target engagement using biomarkers of neuroinflammation and neuronal function.
Preliminary analyses of exploratory endpoints, including MRI, qEEG and CSF biomarkers, were described as encouraging, with MRI findings trending toward stabilization on active treatment.
NeuroTherapia is collaborating with Oxford Brain Diagnostics Ltd to further analyze mri data using the CDM Explore platform. The company claims preclinical studies showed microglial restoration, reduced brain Aß and improved cognition in animal models; the trial was partially funded by an Alzheimer’s Association Part the Cloud grant.
