NeuroScientific Biopharmaceuticals (ASX:NSB) has reported outcomes from recently completed in vitro genotoxicity studies and plasma protein binding studies involving its lead drug candidate EmtinB.
The company described the outcomes as positive and said they support the commencement of first-in-human Phase 1 clinical studies.
Both studies were undertaken by contract research company Eurofins.
The company said 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. This reduces the amount of drug available to distribute in the tissues of the body to reach the site of action.
"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," said the company.
NeuroScientific’s managing director and CEO Matt Liddelow said, “The positive outcomes from these studies are important for progressing our lead drug candidate EmtinB into first-in-human clinical studies.
"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.”
NeuroScientific said it is in the final stages of collating the data from nonclinical GLP toxicity studies to confirm the safety and tolerability of repeat doses of EmtinB in animals prior to commencement of first-in-human Phase 1 clinical studies.