NeuroScientific Biopharmaceuticals Ltd (ASX: NSB) has obtained positive outcomes from recently completed in vitro genotoxicity studies and plasma protein binding studies involving its lead drug candidate EmtinB in the lead up to commencement of first-in-human Phase I clinical studies in 1H 2022.
Both studies were undertaken by leading contract research company Eurofins, US.
Assessing genotoxicity is an integral part of determining the safety profile of novel drug candidates and involves a standard battery of tests designed to identify compounds that damage DNA. In accordance with regulatory guidelines for the conduct of genotoxicity studies, EmtinB was evaluated in standardised bacterial reverse mutation (Ames) and in vitro micronucleus tests and did not exhibit any signs of inducing genetic toxicity.
Plasma protein binding studies assess if a drug attaches to proteins within the blood, which reduces the amount of drug available to distribute into the tissues of the body to reach the site of action. It is essential to understand the plasma protein binding characteristics of a drug in order to accurately predict dosing in first-in-human clinical studies.
NeuroScientific’s Managing Director and CEO, Matt Liddelow, said the degree of binding of EmtinB to plasma proteins was evaluated in human plasma samples and the mean unbound fraction of the drug was determined to be 98%, meaning that 98% of EmtinB that enters the blood circulatory system is available to reach the site of action.
The positive outcomes from these studies are important for progressing our lead drug candidate EmtinB into first-in-human clinical studies,” Mr Liddelow said.
“The genotoxicity results are another significant step in developing the safety profile of EmtinB prior to testing in humans and confirming the protein binding profile of EmtinB in human plasma is important for accurately guiding selection of the first-in-human dose.”
Roadmap
Having previously completed all necessary nonclinical safety studies for its neurology safety programme, conducted in accordance with Good Laboratory Practice (GLP) standards as required, NeuroScientific is in the final stages of collating the data from nonclinical GLP toxicity studies to confirm the safety and tolerability of repeat doses of EmtinBin animals prior to commencement of first-in-human Phase I clinical studies.
This data is expected to be reported in Q1 CY22 and represents a significant de-risking event for the commercialisation of EmtinB and a major milestone for the company.
The safety data from all nonclinical non-GLP and GLP studies will be submitted for review by an independent Human Research Ethics Committee (HREC) for approval to commence the Phase I clinical study. The Company expects to complete this process in Q1 CY22.
Additionally, the company recently completed an independent review process for its neurology safety programme to identity any potential gaps in the safety data that may delay HREC approval, which confirmed that the current data package is suitable to gain approval to conduct a Phase I clinical study.
NeuroScientific has appointed clinical contract research company Linear Clinical Research to undertake its first-in-human Phase I study of EmtinB.