NeuroTherapia Completes Phase 2a Alzheimer's Trial with Positive Safety and Biomarker Results
NeuroTherapia has completed a Phase 2a trial of NTRX-07 in Alzheimer's patients, meeting safety objectives with no treatment-related serious adverse events. Preliminary biomarker analysis shows encouraging results, including MRI findings trending toward stabilization. The oral small molecule targets neuroinflammation and showed positive effects in animal models.
NeuroTherapia, Inc. has completed its Phase 2a clinical trial of NTRX-07 in Alzheimer's Disease patients, achieving its primary safety objectives and showing encouraging biomarker results. The double-masked, randomized trial administered the oral small molecule for 28 days to 48 subjects across sites in Hungary, Poland, and the Czech Republic, with no treatment-related serious adverse events reported in the active arm.
The trial was designed to demonstrate target engagement, safety, and pharmacokinetics while analyzing biomarkers of neuroinflammation and neuronal function. Preliminary analysis of exploratory endpoints, including MRI, qEEG, and CSF biomarkers, indicates some encouraging results, with MRI findings directionally supportive and trending toward stabilization on active treatment. Drug exposure levels were in line with expectations, and the study produced a positive multi-domain signal package across safety, pharmacokinetics, biomarkers, MRI, EEG, and clinical outcomes.
NTRX-07 is a small orally available molecule that targets receptors that increase in diseases including Alzheimer's disease, amyotrophic lateral sclerosis, multiple sclerosis, and chronic pain syndromes. In animal models of Alzheimer's, NTRX-07 restored normal function of microglia, decreased microglial-induced inflammation, reduced levels of the Alzheimer's-associated Aß peptide in the brain, and substantially improved neuronal synaptic plasticity, learning, and memory.
The company is continuing to work with Oxford Brain Diagnostics Ltd on a more thorough analysis of the MRI data, including utilizing its CDM Explore platform to compare MRI results with changes in neuroinflammatory biomarkers, qEEG, and cognitive test results. The trial was managed by CRU Global, which noted considerable interest in participating in future trials expressed by site principal investigators, patients, and caregivers.
This study was funded in part by a grant from the Alzheimer's Association Part the Cloud program. NeuroTherapia is a clinical-stage, privately held biotechnology company spun out of the Cleveland Clinic, developing oral, small-molecule drugs to address neuroinflammatory conditions of the central nervous system.