ANNUAL REPORT FY22 19 Preclinical Safety and Toxicity Studies Safety, pharmacology, and toxicology studies are anticipated to begin in Q3 CY2022. These studies will evaluate the safety and tolerability of Nyrada’s lead brain injury drug candidate in research models. Data from these studies will determine the safe starting dose for the Phase I first-in-human study. Manufacture of the batch of drug to be used in the preclinical and clinical studies has been completed and is now undergoing formulation development to deliver a dose form suitable for intravenous administration. The necessary formulation development work is being undertaken at a leading US based CRO from mid-September and is expected to take between 2 - 6 weeks to complete. This formulation work does not impact on the timing of cell-based in vitro safety and toxicology studies, which are due to commence in Q3 CY2022. However, this formulation work must be completed prior to the commencement of the in vivo safety and toxicology studies to ensure optimal drug delivery. The ongoing COVID-19 pandemic has led to an industry wide constraint on resources and complicated logistics, resulting in a lack of availability of GLP study slots, making scheduling preclinical work with CROs challenging. The Company is in regular contact with the CRO to ensure these studies are expedited. Phase I Study Pending completion of the FDA mandated preclinical safety and toxicology studies and ethics committee approval of the trial protocol, recruitment, and dosing of the first participant is expected to commence in H1 CY2023. The Phase I study will be run in Australia and will evaluate the safety and tolerability of NYR-BI02. The trial participants will be split into 5 groups of 8, with 6 receiving the drug and 2 receiving a placebo. Blood samples will be drawn several times throughout the study period and analysed for drug levels. Participants will be monitored for clinical signs throughout the study duration. The study will support the development of Nyrada’s drug in both TBI and stroke indications, significantly expanding the commercial opportunities available to the Company. Objectives • To assess the safety, tolerability, and pharmacokinetics of NYR-BI02 Design (subject to ethics approval) • Randomized, double-blind placebo –controlled, dose escalation design • 5 cohorts; 8 participants each cohort; 6:2 active and placebo treatments • 3 cohorts will be single ascending doses • 2 cohorts will be given continuous infusion doses Participants • Male and female healthy volunteers • 18 – 50 years age Cohort number Dose administered 1 Low dose single bolus 2 Medium dose single bolus 3 High dose 4 Low dose continuous infusion (72 hrs) 5 High dose continuous infusion (72 hrs) Location & Duration • Study will be conducted at a clinical trial center in Australia • The study duration will vary between 1 – 4 days Cohorts 1-3 Cohorts 4-5 Day 1 Day 2 Day 10 Continuous infusion Day 7 Day 3 Bolus delivery Safety assessment Safety assessment
RkJQdWJsaXNoZXIy MjE2NDg3