- NeuroScientific Biopharmaceuticals (NSB) records no adverse events during its non-clinical studies of EmtinB
- The trials sought to determine the potential for any adverse effects on the central nervous, cardiovascular and respiratory systems, forming a key element to gaining regulatory approval to start Phase 1 clinical studies
- NSB is now undertaking final trials of its non-clinical neurology safety program in two animal species, which it expects complete in Q4 2021
- NSB says it’s working closely with its clinical development partner to schedule its Phase I clinical study to launch at the earliest date possible following the safety program
- NeuroScientific Biopharmaceuticals closed down 3.75 per cent at 38.5 cents per share
NeuroScientific Biopharmaceuticals (NSB) has seen no adverse events during its non-clinical studies of EmtinB.
EmtinB is a therapeutic peptide targeting Alzheimer’s disease and glaucoma, as well as other Emtin peptides.
The studies formed a crucial element of a safety evaluation necessary to gain regulatory approval to start Phase 1 clinical studies. The trials looked to determine the potential for any adverse effects on the central nervous, cardiovascular, and respiratory systems.
“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,” NeuroScientific’s CEO and Managing Director Matt Liddelow said.
The company said not meeting safety requirements remained one of the key reasons for failure in preclinical and early-phase clinical studies, which sees 48 per cent of drugs not progress to clinical trials.
NSB is now in the midst of undertaking non-clinical, four-week GLP toxicity studies in two animal species. These are the final trials of its non-clinical neurology safety program and are expected to be complete in the fourth quarter of 2021.
The company said it’s working closely with its clinical development partner, Linear Clinical Research, to schedule its Phase I clinical study to launch at the earliest date possible, following the non-clinical neurology safety program.
“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.
NeuroScientific Biopharmaceuticals closed down 3.75 per cent at 38.5 cents per share.