NeuroScientific Biopharmaceuticals Ltd. to report positive outcomes from its Preclinical Safety and Toxicology Program involving lead drug candidate EmtinB, undertaken to support the commencement of first-in-human clinical trials. EmtinB demonstrated an impressive safety profile in multiple animal species, including pivotal GLP Toxicology studies of daily doses up to 20x above the predicted efficacious dose-range in humans, with no major adverse effects or toxicology findings attributed to EmtinB. Pivotal toxicology studies in animals are considered the most important studies in assessing the safety of drug candidates prior to testing in humans and must be completed in line with ICH guidelines 1 and compliant with `Good Laboratory Practice' (GLP) standards to ensure the quality and integrity of the resulting data.

The safety outcomes from the GLP studies for EmtinB include: GLP toxicology studies established that doses as high as 100mg/kg/day over a period of 28-days did not result in any major safety concerns. No reported occurrences of organ damage or incidences of macroscopic changes in tissues to indicate damage following daily dosing for up to 28-days. 100% survival rate at the conclusion of the dose period across all GLP toxicology studies.

The safety margin for the predicted dose range in humans substantially exceeds the standard requirement of regulatory agencies, such as the TGA and the FDA. Advancing EmtinB into first-in-human clinical trials: NeuroScientific expects to receive approval from Human Research Ethics Committee (HREC) during May 2022 allowing the Company to commence a first-in-human clinical trial for EmtinB during first half of 2022.