Nyrada Inc (ASX: NYR) has reported it has made significant progress made on the pilot traumatic brain injury preclinical study under the Nyrada- UNSW-WRAIR collaboration.
Preclinical TBI Efficacy Study Progress
Last year, Nyrada announced a three-way collaboration with UNSW Sydney and the Walter Reed Army Institute of Research (WRAIR) to evaluate the efficacy of its brain injury drug candidate in two preclinical models of traumatic brain injury (TBI): Controlled Cortical Impact (CCI) and Penetrating Ballistic Brain Injury (PBBI).
These models represent two different modes of injury, one as a direct head trauma (CCI) and the other mimicking a bullet or shrapnel wound (PBBI), reflecting serious head injury relevant to active military service members.
In the lead-up to the efficacy study with Nyrada’s brain injury drug candidate, a pilot study is being conducted to optimise the design of the efficacy study. Brain samples from the CCI and PBBI models have been collected from WRAIR and are currently undergoing assessment at the Translational Neuroscience Facility of UNSW, utilising their sophisticated MRI technology (T2-weighted and Fractional Anisotropy MRI) to establish the nature and extent of injury. This reflects brain imaging technology used in hospital emergency rooms.
A key focus of this pilot study is to refine the location and extent of injury in each model and select optimal timepoints to assess a therapeutic effect of Nyrada’s drug in preventing secondary brain injury. This data will allow the Company to ascertain the number of animals that will be required to provide a meaningful assessment of the therapeutic effect of Nyrada’s drug.
Professor Gary Housley, Chair of the Nyrada Scientific Advisory Board, and research head of the UNSW Translational Neuroscience Facility, reports that the imaging of the brain injury models provided to UNSW by the WRAIR Brain Trauma Neuroprotection team are providing key data for powering the Nyrada brain injury rescue drug study.
Testing Nyrada’s Brain Injury Drug Candidate in Stroke
Nyrada will evaluate the efficacy of the company’s brain injury drug candidate in a well-established preclinical stroke model in the first quarter of this year. The model is called the Photothrombotic Model of Ischemia, where localised clot formation is achieved in a specific brain region leading to a stroke. This model was previously used by Nyrada to test the efficacy of its first-generation molecule, which showed a promising efficacy signal.
This work is outside of the studies being undertaken as part of Nyrada’s collaboration with WRAIR and UNSW. WRAIR’s focus remains solely on developing a drug to mitigate the impact of TBI on military service members.
A key advantage of the drug that Nyrada is developing is that it can be administered to stroke and TBI patients in the same manner, by way of intravenous dosing over a 3-day period, which is matched to patient emergency hospital admission.
The development of this model presents an exciting step forward in Nyrada’s strategy to evaluate the efficacy of its brain injury drug candidate to reduce the impact of secondary brain injury in patients following a stroke, as well as TBI,” Nyrada CEO, James Bonnar said.
Pathway to Phase I Study
Nyrada expects to commence a Phase I first-in-human study for its Brain Injury Program in the second half of CY2022. The Phase I study will be run in Australia and will evaluate the safety and tolerability of the Company’s brain injury drug candidate.