NeuroScientific Biopharmaceuticals Ltd (ASX: NSB) has submitted an application for Human Research Ethics Committee (HREC) approval to commence a Phase I clinical trial of lead drug candidate EmtinB, 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 EmtinB 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 EmtinB in cerebrospinal fluid (CSF) samples. The primary endpoint of this clinical trial is the safety and tolerability of EmtinB versus placebo.
The Phase I clinical trial has been designed to support Phase II clinical trials of EmtinB 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.
Coming off the back of the recent significant milestone of recruiting the first subject for our early-phase clinical trial, we are very excited to be submitting the HREC application for this important large-scale Phase I clinical trial of EmtinB that will provide human safety data to support multiple Phase II clinical trials in patients with neurodegenerative conditions, starting with Multiples sclerosis and Alzheimer’s disease,” Managing Director and Chief Executive Officer, Matt Liddelow, said.
NeuroScientific recently achieved the historic milestone of HREC approval to commence the company’s very first clinical trial of EmtinB, an early-phase clinical trial largely focused on the assessment of biomarkers in human blood samples that indicate proof of the mechanism of activity of EmtinB in humans, and subsequently announced the first subject recruited for the trial.