- NeuroScientific Biopharmaceuticals’ (NSB) eye treatment drug, EmtinB, passes safety and tolerability markers in a recent study
- The ocular safety and tolerance study assessed the drug administered by an eye injection, in non-human primates over a 28-day period
- Preclinical lab services company, Toxikon, completed the study, finding no signs of inflammation or abnormalities
- The results are noted as a major advancement for the company in its research and development program in the lead up to starting a Phase I clinical study
- Shares are down 1.49 per cent at 33 cents at 12:34pm AEST
NeuroScientific Biopharmaceuticals (NSB) eye treatment drug, EmtinB, has passed safety and tolerability markers in a recent study.
EmtinB is a therapeutic peptide, developed to initially target Alzheimer’s disease and glaucoma.
The ocular safety and tolerance study assessed the drug administered by intravitreal (meaning inside the eye) injection, in non-human primates over a 28-day period.
Preclinical lab services company, Toxikon, completed the study, finding no signs of inflammation or abnormalities.
Additionally, the study investigated low-, mid- and high-dose study groups, with the high-dose group establishing a safety margin three times greater than the planned clinical dose.
While the intravitreal injection of drugs is increasingly used for the treatment of a wide variety of retinal diseases, NSB remains cautious as adverse events and complications of this method can result in drugs being suspended from further development before reaching the market.
Therefore, the company believes ensuring intravitreal therapy is safe, is paramount in order to achieve significant adoption and strong sales.
On this, recently appointed Non-executive Chairman Paul Rennie commented that “no adverse results in a well-established preclinical model” will be “very interesting to those pharmaceutical companies developing novel ophthalmic products”.
NSB is progressing its ocular research and development (R&D) program in a bid to transition from preclinical to the first in-man studies in the second half of calendar year 2021.
CEO and Managing Director Matt Liddelow said the safety results are a “major advancement” for the R&D program in the lead up to a phase one clinical study.
“Collectively, these positive results, combined with all non-clinical safety
data generated to date, provide significant confidence in our progress towards
developing EmtinB as a safe and effective treatment for ocular conditions that
damage the optic nerve, such as glaucoma which is one of the leading causes of
blindness globally.”
Additionally, the company said its preclinical ocular safety program is well-advanced with safety pharmacology studies due to report by next month.
Another ocular efficacy study, involving an ocular occlusion animal model, is set to report in the same period.
Shares were down 1.49 per cent at 33 cents at 12:34pm AEST.