NeuroScientific Biopharmaceuticals (ASX:NSB) has submitted an application seeking approval for an early-phase clinical trial involving its lead drug candidate EmtinB.
The company said it is on schedule to complete the milestone of commencing clinical development of EmtinB in the first half of 2022.
Managing director and CEO Matt Liddelow said, “I’m pleased to report that NeuroScientific has submitted a very robust data package and clinical trial plan for HREC review and we remain on schedule to achieve the major milestone of commencing clinical development of EmtinB during 1H 2022.
“Most importantly, the company is one step closer to bringing a much-needed therapeutic option with disease-modifying potential to patients with Alzheimer’s disease and Multiple Sclerosis. With the HREC review process underway and other supporting activities well-advanced, NeuroScientific has officially transitioned from being a preclinical to a clinical stage company.”
The company said an important focus of this study will involve the assessment of biomarkers in human blood samples that indicate proof of the mechanism of activity of EmtinB in humans and can be used to guide efficacy outcomes during future trials in patients. The clinical trial will include up to 30 healthy participants and will be undertaken by leading WA-based clinical research partner Linear Clinical Research.