NeuroScientific Biopharmaceuticals Ltd. announce it has submitted an application for Human Research Ethics Committee (HREC) approval to commence a Phase I clinical trial of lead drug candidate EmtinBTM, achieving another important milestone in the progression of EmtinB as a first-in-class treatment with disease modifying potential for Multiple sclerosis and Alzheimer's disease. The Phase I clinical trial is a double blind, placebo controlled, dose-escalation study designed to establish the safety profile, pharmacokinetics and pharmacodynamics of EmtinBTM in up to 88 healthy adult volunteers. The clinical trial will be a single site study undertaken by Linear Clinical Research (Nedlands, WA) and will include an initial single ascending dose (SAD) study, followed by a multiple ascending dose (MAD) study, and a separate study arm to investigate the concentrations of EmtinBTM in cerebrospinal fluid (CSF) samples.

The primary endpoint of this clinical trial is the safety and tolerability of EmtinBTM versus placebo. The Phase I clinical trial has been designed to support Phase II clinical trials of EmtinBTM for the treatment of patients with Multiple sclerosis and Alzheimer's disease. Since this clinical trial will be conducted in healthy volunteers rather than in patients, the safety data is also expected to support the progression of EmtinBTM into Phase II clinical trials for a range of neurodegenerative conditions in the future.