Nyrada is currently undertaking a pilot study to optimise the design of the efficacy study to evaluate its brain injury drug candidate in two traumatic brain injury (TBI) models: Controlled Cortical Impact and Penetrating Ballistic Brain Injury. These two models represent two different modes of brain injury, one as a direct head trauma and the other mimicking a bullet or shrapnel wound. These types of injuries are common amongst active military personnel.
A key focus of the study is to refine the location and extent of injury in each model and select optimal timepoints to assess the therapeutic effect of Nyrada’s drug candidate in preventing secondary brain injury, which occurs after the TBI due to excitotoxicity. Excitotoxicity occurs when a wave of chemicals are released from the dead and dying brain cells affected by the original injury. These chemicals diffuse out from the core injury, over-stimulating healthy brain cells surrounding the core injury to the point of causing their death. This secondary wave of brain cell death can more than double the size of the original core injury, thereby contributing significantly to any long-term disability. Data from the current pilot study will help to ascertain the number of animals that will be required to provide a meaningful assessment of the therapeutic effect of the company’s drug.
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. This means that the company expects to have two phase one trials running concurrently during the second half of 2022 which will be an exciting time for shareholders.ASX RELEASE 04.01.2022