NeuroTherapia has concluded its Phase IIa clinical trial of NTRX-07, an orally available molecule, for Alzheimer’s disease treatment.
The randomised, double-masked trial evaluated the pharmacokinetics, safety, and clinical efficacy of a 28-day administration of NTRX-07 in Alzheimer’s patients.
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It also evaluated target engagement through analysis of biomarkers linked to neuroinflammation and neuronal function.
The primary endpoint was safety and tolerability, which was met. Adverse events were similar in both treatment and placebo groups. No treatment-related serious adverse events were identified in the active arm.
Preliminary review of exploratory endpoints, including magnetic resonance imaging (MRI), quantitative electroencephalogram (EEG), and cerebrospinal fluid (CSF) biomarkers, indicates encouraging trends.
MRI findings, guided by the hypothesis regarding neuroinflammation and Alzheimer’s progression, showed changes toward stabilisation for patients on active treatment.
NeuroTherapia is collaborating with Oxford Brain Diagnostics for detailed MRI analysis, using the cortical disarray measurement (CDM) Explore platform to compare MRI data with changes in neuroinflammatory biomarkers, quantitative EEG, and cognitive outcomes.
The trial was managed by CRU Global and conducted in Hungary, Poland, and the Czech Republic, enrolling 48 subjects using a 1:1 randomisation across five sites.
It received support from the Alzheimer’s Association Part the Cloud programme.
NeuroTherapia chief medical officer Dr Joseph Foss said: “We are pleased to see that NTRX-07 continues to be safe and well-tolerated in patients with Alzheimer’s, and that drug exposure levels were in line with what we expected, demonstrating a positive outcome.
“Following the preliminary analysis of the exploratory endpoints, the study met its core Phase IIa objectives and produced a positive multi-domain signal package across safety, PK, biomarkers, MRI, EEG, and clinical outcomes. This supports confidence in the further development of this new approach to treating Alzheimer’s.”
