Motiva™ (nefiracetam)

Motiva™, a novel cyclic (GABA) derivative, is being developed by Neuren for neuropsychiatric and neurocognitive symptoms of stroke and other acute and chronic neurological disorders including Parkinson’s disease and Alzheimer’s disease.

Completion of the acquisition of Hamilton Pharmaceuticals gave Neuren access to Motiva™ (nefiracetam), currently in late Phase 2 clinical development.

To date, seven clinical trials in humans have been conducted in Japan, the US and Canada in post-stroke patients. The clinical trials confirmed the safety of Motiva™ and showed that Motiva™ improved neuropsychiatric symptoms (apathy or abulia), cognitive function (via the Symbol Digit Modality Test, a measure of frontal lobe function) and activities of daily living (as measured by the Functional Independence Measure).

Neuren will proceed with a Phase 2b trial of Motiva™ under Hamilton’s open US
Investigational New Drug (IND) application. The trial is expected to run for around 12 months. It will incorporate a broader range of endpoints and more stringent patient selection criteria in order to provide the basis
for a pivotal trial.