Nyrada (ASX:NYR) has completed a dog toxicology study, reinforcing the safety and tolerability of its lead brain injury drug candidate, NYR-BI03.
The 14-day study adhered to Good Laboratory Practice conditions, focusing on aspects such as general health, body weight, clinical pathology, and pharmacokinetics, vital for gauging drug exposure.
The company chose dogs due to their physiological similarities with humans, particularly in drug metabolism.
Nyrada's recent study involved administering doses higher than the planned human dose, which further supports the safety profile of NYR-BI03.
This follows their standard practice of conducting GLP studies on two animal species—in this case, dogs and rats—to ensure data reliability and identify species-specific reactions.
"We are very pleased with the favourable safety outcomes seen in both rats and dogs, which bolster our confidence in translating these findings to human studies," said John Moore, non-executive chair of Nyrada.
Previous preclinical studies on NYR-BI03 showed neuroprotective effects, rescuing 42% of brain tissue in the penumbra region.
The company expects to initiate the first-in-human Phase 1 clinical trial for NYR-BI03 in late 2024, pending further successful completion of GLP studies.
Nyrada continues to focus on neuroprotection for stroke and traumatic brain injury, aiming to address significant unmet clinical needs with NYR-BI03.