NeuroScientific Biopharmaceuticals Ltd (ASX: NSB) has successfully completed the programme of non-clinical Safety Pharmacology studies which form a key element of the safety evaluation necessary to gain regulatory approval to start Phase I clinical studies on the company’s lead drug candidate EmtinB.
The programme was undertaken by LabCorp Inc, US to Good Laboratory (GLP) Standards and involved the core battery of studies to determine the potential for any adverse effects on the central nervous system (CNS), cardiovascular (CV) system, and respiratory system (RS).
Unacceptable safety remains one of the most important reasons for failure in preclinical and early-phase clinical studies, with 48% of drugs not progressing into Phase I clinical trials due to safety concerns.
In addition to GLP Toxicity studies, GLP Safety Pharmacology studies are pivotal studies in identifying potential adverse liabilities of a drug before progressing to testing in humans.
EmtinB completed the programme of non-clinical Safety Pharmacology studies without causing any adverse liabilities. The company is currently undertaking non-clinical four-week GLP Toxicity studies in two animal species, which are the final pivotal studies of its non-clinical neurology safety programme and are expected to be completed in Q4 2021.
CEO and Managing Director, Matt Liddelow, said NeuroScientific is working closely with its clinical development partner Linear Clinical Research to schedule its Phase I clinical study to initiate at the earliest date possible following conclusion of the non-clinical neurology safety programme.
We are very pleased to have completed another major determinant of safety with EmtinB as we finalise the remaining non-clinical studies in the lead up to starting our first-in-human Phase I clinical trial. The company is at an incredibly exciting point in its existence as we progress towards initiating clinical studies and I look forward to providing further updates in the near future,” Mr Liddelow said.
EmtinB is a peptide-based compound that binds to surface-based cell receptors from the LDLR family, activating intracellular signalling pathways that stimulate neuroprotection, neuro-regeneration and modulate neuroinflammation. EmtinB is modelled on a specific active domain of the complex human protein called Metallothionein-IIA, which is produced as part of the human body’s innate immune response to cell injury.
