Australian preclinical drug development company Nyrada (ASX:NYR) has provided an update on the progress of its small molecule cholesterol-lowering program.
The company said a previous in vivo preclinical study showed NYX-PCSK9i reduced total cholesterol by 57 per cent without adverse side effects. It said it has now commenced a new in vivo efficacy study in the same specialised transgenic mouse model to evaluate NYX-PCSK9i in combination with a statin.
Nyrada said the study aims to determine if NYX-PCSK9i enhances the efficacy of a statin when co-administered.
It also said recent medicinal chemistry work has revealed two promising drug candidates (NYX-PCSK9i-211 and NYX-PCSK9i-212) with in vitro testing confirming they have improved potency and bioavailability compared to NYX-PCSK9i.
"These new candidates may be less prone to interactions with drugs prescribed to patients with high cholesterol," said the company. "Consequently, the new in vivo high cholesterol mouse study has been expanded to evaluate the efficacy of these new drug candidates."
Nyrada said it has also selected a preferred contract research organisation (CRO) to oversee the preclinical safety and toxicology studies that are necessary before human clinical trials can commence.
Commencement of the preclinical safety and toxicology studies is dependent on having sufficient amounts of the clinical candidate available, said the company, adding, "Nyrada is optimising the route of synthesis for these compounds as it scales up from gram to kilogram quantities, which are required for these studies."
CEO James Bonnar said, “Nyrada has built a strong portfolio of novel compounds that strengthen our intellectual property and create licensing opportunities for the Program. We are confident that scale-up manufacturing combined with the improved potency and drug-likeness of the new compounds, compared to the positive results of NYX-PCSK9i, ensures we will enter Phase I clinical trials with the optimal drug candidate.”
The company also reported it has received a $976,372 cash rebate under the federal government’s R&D tax incentive program. The rebate relates to expenditure incurred on eligible R&D activities conducted during the 2020 financial year.