NYRADA INC (ASX:NYR) 10 Good Laboratory Practice Safety Studies In March 2024, Nyrada commenced Good Laboratory Practice (GLP) safety studies for NYR-BI03. GLP studies are a regulatory precursor to a first-in-human clinical trial with their purpose being to ensure safety before testing in humans. Following the conclusion of the 2024 financial year, two of the requisite GLP studies were completed: • AMES (Bacterial Reverse Mutation) evaluated the mutagenicity and predicted the genetic risks and potential carcinogenic effects of NYR-BI03. • hERG (Human Ether-a-go-go-related Gene) evaluated the cardiovascular safety of NYR-BI03. NYR-BI03 demonstrated requisite safety in these two (in vitro) studies. The remaining GLP safety studies are on track to be reported in the fourth quarter of the 2024 calendar year. Walter Reed Army Institute of Research Study Nyrada’s collaborative TBI study with the Walter Reed Army Institute of Research (WRAIR) commenced early in the fourth quarter of the 2024 financial year. This study assesses the efficacy of NYR-BI03 in a rodent model of penetrating TBI, which seeks to mimic the serious head injuries suffered by military service members. The degree to which NYR-BI03 provides neuroprotection following a penetrating TBI will be assessed and measured. The study has progressed through the controlled injury phase with all MRI images and associated analysis to be conducted at UNSW Sydney. The MRI imaging is underway and statistical analysis to follow, with study results now expected to be available in 1QCY2025. Phase I Clinical Trial Subject to the successful completion of GLP studies, Nyrada remains on track to commence its first-in-human Phase I clinical trial for NYR-BI03 late in this calendar year. This study will assess the safety and tolerability of the drug in healthy human volunteers and will seek to confirm the safe dose range to take forward into subsequent clinical trials. The design and budget for this Phase I trial is subject to final GLP study results and is thus still being finalised. However, design and cost will be moderated by the study’s conduct in Australia and with healthy human volunteers. Rebion Strategic Partnership In late June 2024, Nyrada signed a Strategic Partnership Agreement (SPA) with Boston-based medical device development company Rebion. Rebion uses Neural Performance Scanning technology to identify and monitor functional impairments in the brain stemming from disease or injury. Through this SPA, Nyrada and Rebion intend to collaborate to advance therapies and outcomes for TBI sufferers. This includes joint research, conference presentations, and applications for non-dilutive funding grants. A mid-term goal of the SPA is to conduct a joint study assessing the efficacy of Nyrada’s brain injury therapy with Rebion’s brain injury detection and monitoring capabilities; potentially as part of Nyrada’s Phase II trial of NYR-BI03. “Nyrada’s collaborative TBI study with the Walter Reed Army Institute of Research commenced early in the fourth quarter of the 2024 financial year… with results now expected to be available in 1QCY2025.”
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