NeuroTherapia, Inc, a US-based clinical-stage company, announced on Tuesday that the European Medicines Agency (EMA) has approved the company's Phase 2 clinical trial of its lead molecule NTRX-07.

In the double-masked, randomised clinical trial, NTRX-07 will be administered to Alzheimer's disease (AD) participants for 28 days.

In addition to monitoring safety, pharmacokinetics and standard measures of clinical efficacy, the trial is also designed to give an indication of target engagement by analysing various biomarkers of neuroinflammation and neuronal function.

CRU Global, a Europe-based CRO, is managing the trial and it will be conducted at sites in Hungary, Poland and and the Czech Republic. Sites are currently completing training for administrating qEEG and P300 ERP recordings, with patient enrolment expected to commence in February.