Aussies suffering from Alzheimer’s disease may have avoided some sketchy science after drug development company Neuroscientific Biopharmaceuticals (ASX: NSB) had their application to commence Phase 1 trials in humans, rejected by the Human Research Ethics Committee (HREC). 

In order for any drug development company to commence trials in humans, they must secure HREC approvals which detail the intentions of the trials, and how they will be conducted. Given the sketchy history around human trials, these regulatory processes are in place to prevent humans participating in trials that fail to meet ethical guidelines. Such processes were not in place when the Tuskegee Syphilis Study took place… 

The exact reason behind the HREC rejection for Neuroscientific Biopharmaceuticals Phase 1 trials of their flagship EmtinB drug was limited in public disclosures but was based on “the supporting documentation did not sufficiently address the risk-benefit profile to justify the conduct of the planned Phase I Clinical Trial,” according to the Company. 

Neuroscientific Biopharmaceuticals will seek further clarification behind the rationale of the decision but for the development of EmtinB to be halted before even reaching Phase 1 human trials is a big blow for the Company. 

Based on data collected from animal studies, EmtinB is a peptide-based compound that stimulates neuroregeneration and modulates neuroinflammation. 

Degeneration of brain tissue is one of the precursors to Alzheimer’s disease, as well as glaucoma which Neuroscientific Biopharmaceuticals is also targeting with EmtinB.  

With development of EmtinB having burnt a fair bit of cash to reach this stage, including $10.4m in losses in 2022 and $3.2m in 2021. Considering their flagship drug has been rejected before a single human dose was administered, it’s not gonna be a good day for NSB shares which last closed at $0.215 before the Company confirmed the HREC rejection.