NeuroScientific Biopharmaceuticals Ltd (ASX: NSB) has submitted an application for an early-phase clinical trial involving lead drug candidate EmtinB.
The application for Human Research Ethics Committee (HREC) approval, confirms the company is on schedule to complete the significant milestone of commencing clinical development of EmtinB in 1H 2022.
The timeline for approval is expected to be consistent with NeuroScientific’s plans to commence the clinical trial in June 2022.
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,” NeuroScientific’s Managing Director and Chief Executive Officer, Matt Liddelow, said.
“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 early-phase clinical trial is the initial stage of the clinical development program involving EmtinB.
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 importance of this data is highlighted by the high rate of attrition for drugs in Phase II clinical trials, with up to 70% failing due to lack of efficacy.
This clinical trial will include up to 30 healthy participants and will be undertaken by leading WA-based clinical research partner Linear Clinical Research.