Drug discovery and development company Nyrada (ASX:NYR) has provided an update on preclinical studies as part of its Brain Injury Program.
The company says the formulation development work necessary to ensure that it can deliver an optimal dose form suitable for intravenous administration of its brain injury drug candidate is ongoing and progressing well.
Nyrada adds that its in vitro safety and toxicology studies are progressing well, with in vivo studies to follow. These required preclinical studies are expected to be utilised to evaluate the safety and tolerability of the company’s drug and represent a necessary part of the drug development process, given Nyrada’s candidate has not been tested in humans.
“This work is critical to the remaining preclinical and phase one studies and we are very pleased with the results to date”
It is reported that data from these studies will determine the safe starting dose for the phase one study.
The company also notes that the efficacy of its brain injury drug candidate is currently being evaluated within a well-established preclinical stroke model, which was previously used by the Nyrada to test the efficacy of its first-generation molecule.
Adding on to this, Nyrada announced that the stroke model study would be conducted in Q4 2022, however additional time has been required to progress the formulation development work and has resulted in a slight delay to the commencement of the study.
Results from the stroke model study are now expected to be made available during the first quarter of 2022.
Speaking on the program, Nyrada Chief Executive Officer (CEO) James Bonnar said: “The team has been working closely with the US based Contract Research Organisation engaged to undertake the formulation development work for our brain injury drug candidate. This work is critical to the remaining preclinical and phase one studies and we are very pleased with the results to date.
This year represents a key turning point for the company, with both our Brain Injury and Cholesterol-Lowering Drug development programs expected to commence phase one clinical trials during the first half of 2023. The team and I are excited for what lies ahead.”
Nyrada is an ASX-listed preclinical stage drug development company that specialises in novel small molecule drugs in order to treat cardiovascular and neurological diseases. The company currently has 2 main programs that are both targeting market sectors of ‘significant’ size and considerable unmet clinical need. These programs are being conducted for a cholesterol-lowering drug and a drug to treat brain injury, specifically traumatic brain injury and stroke.