NeuroScientific Biopharmaceuticals (ASX:NSB) says it has submitted an application for Human Research Ethics Committee (HREC) approval to commence a Phase I clinical trial of its lead drug candidate EmtinB.
The candidate is a first-in-class treatment being investigated 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 in Western Australia. It 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 company said the primary endpoint of the trial is the safety and tolerability of EmtinB versus placebo. It said the Phase I trial has been designed to support Phase II trials of EmtinB for the treatment of patients with Multiple sclerosis and Alzheimer’s disease.
Managing director and CEO Matt Liddelow said, “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.”