- NeuroScientific Biopharmaceuticals (NSB) has completed two ocular pharmacokinetic (PK) and tissue distribution studies of its EmtinB candidate
- NSB develops peptide-based drugs for the treatment of neurodegenerative conditions such as Alzheimer's disease and glaucoma
- The two Australia and U.S.-based studies in rabbits will precede phase one clinical trials of the drug in humans
- NSB says recent results verify the "impressive" bioavailability of intravitreally-delivered EmtinB
- The findings bolster the potential of the drug to be administered through less invasive methods, such as eye drops
- NSB completed a four-week ocular tolerance and safety study in non-human primates in March and expects to deliver results later in the quarter
- Shares have spiked 1.89 per cent to trade at 26 cents each
NeuroScientific Biopharmaceuticals (NSB) has completed two ocular pharmacokinetic (PK) and tissue distribution studies ahead of commencing phase one clinical studies in humans.
NSB develops peptide-based drugs for the treatment of neurodegenerative conditions such as Alzheimer's disease and glaucoma.
The company is progressing its ocular research and development (R&D) program in a bid to transition from preclinical to clinical development this year.
Ocular PK and distribution studies in rabbits
Neuroscientific completed its most recent ocular PK studies in rabbits to determine the bioavailability of its EmtinB candidate in the eye.
NSB says a detailed knowledge of PK is important for human clinical trials because it establishes the frequency of dosing in patients.
In one study, conducted by the Lion's Eye Institute in Perth, researchers detected a single dose of EmtinB labelled with a fluorescent tag in all ocular tissue samples, including those from the retina and optic nerve, up to the final time point of six days.
The results significantly exceeded the study's minimum target end point of three days.
In parallel, Toxikon conducted a larger ocular PK study of rabbits in Massachusetts.
Researchers detected the drug in all ocular fluid samples across the entire dose range up to the final time point of 14 days.
NBS says all close groups remained within the therapeutic concentration range past four days and significantly exceeded the three-day minimum end point.
Together, NSB says the studies verify the "impressive" bioavailability of intravitreally-delivered EmtinB and indicate strong potential for a patient dosing regimen of four to six-week intervals.
Further, the results have bolstered the potential of the drug to be administered via a less invasive method, such as eye drops.
NSB is set to begin studies in the second half of the year to investigate alternative delivery methods.
Ocular tolerance and safety in non-human primates
Meanwhile, the company completed a four-week ocular tolerance and safety study in non-human primates in March, for which results are still pending.
A three-month safety study in non-human primates is also scheduled to begin later this year.
NSB expects this study will provide further safety data for future longer-term clinical studies and support potential licensing deals with prospective partners.
The company's managing director and CEO Matt Liddelow commented on the work.
"We are pleased to report these significant achievements in our R&D program, while continuing to remain acutely focussed on progressing EmtinB into safety studies in humans," he said.
"The impressive PK data means we have flexibility with patient dosing in clinical studies and the tissue distribution data gives us confidence in investigating non-invasive methods of delivery."
NSB expects to deliver results for its non-human primates study later this quarter.
NeuroScientific Biopharmaceuticals shares have spiked 1.89 per cent to trade at 26 cents at 3:22 pm AEST.