Ethics committee (HREC) knocked the trial back due to localised...

Ethics committee (HREC) knocked the trial back due to localised irritation (toxicity) at the injection site, impurities in the serum, and insufficient evidence of efficacy caused by the company opting to use the dendritic form of EmtinB rather than the dimeric form primarily used in the original research paper. The dendrimer had lower efficacy than the dimer.

Then we had a looong period of nothing while the company tried to find a CEO. When Stephen Carter joined the company and conducted a strategic review, there were some other quite critical issues raised:

• Although EmtinB had efficacy in vitro there was no confidence that an injection into the bloodstream would result in sufficient active constituent crossing the blood-brain barrier to be effective in treating the targeted neurological disorders (MS, Alzheimer's).
• The remaining exclusive licence period for developing the drug is too short for the company to pursue for the company to continue low-confidence research directions.

These issues are behind the company's decision to pivot away from central nervous system disorders toward Glaucoma. This was principally because the drug is injected directly into the treatment site, resolving the issue of getting sufficient active constituent to the treatment site.

In my view, Glaucoma is all systems go once the FDA approve the trial.