Drug development company Nyrada (ASX:NYR) has completed its preclinical Good Laboratory Practice (GLP) studies, which were required by regulators to evaluate the safety and tolerability of its cholesterol-lowering drug candidate.
The company says it is on track to begin its phase 1/2a first-in-human study in early 2H CY2023.
Commenting on the company’s milestone, Nyrada Chief Executive Officer (CEO) James Bonnar says: “The completion of the preclinical GLP studies and receipt of the draft study reports will allow us to finalise our ethics submission and bring us closer to the initiation of our phase 1/2a first-in-human study.
Nyrada’s cholesterol-lowering drug is taking an optimal approach to PCSK9 inhibition that is cost competitive and prioritises patient convenience, compared to the current available injectable drugs.”
The company has engaged with Scientia Clinical Research to run the study, which will be assessing the safety and tolerability of Nyrada’s drug candidate, alongside providing an early indication of the drug’s efficacy in the target patient population.
Additionally, phase 1/2a development will be carried out in 2 stages. The first stage will comprise single oral doses being administered to healthy volunteers to determine safety and tolerability.
Meanwhile, the second stage will involve dosing participants over a 14-day period to determine the safety and tolerability and pharmacokinetics, alongside exploring drug efficacy in patients with high cholesterol.
Nyrada is an ASX-listed preclinical stage, drug discovery and development company, specialising in novel small molecule drugs to treat cardiovascular and neurological diseases.