Nyrada Inc - Annual Report 2021

NYRADA INC (ASX:NYR) 8 CEO Report Dear Shareholders, I am pleased to provide an update on Nyrada’s activity for the 2021 financial year, a busy and productive year for the Company. The team has made significant progress in both our key drug development programs for Cholesterol-Lowering and Brain Injury, resulting in encouraging preclinical data that positions us well for completing the remaining safety and toxicology studies before we commence Phase I trials. Cholesterol-Lowering Program Our Cholesterol-Lowering Program recently delivered very promising results in a second preclinical efficacy study using a specialised mouse model. In an in vivo study, NYX-PCSK9i was shown to reduce total cholesterol by 46%when administered on its own and by a further 65%when given in combination with a statin. Pleasingly, NYX-PCSK9i outperformed the statin drug Lipitor® in the same study, which reduced total cholesterol by 27%. These results build on an earlier, similar dose-range finding and efficacy study, and are particularly encouraging because the mouse model used in these studies possesses important human-like characteristics with respect to cardiovascular health, making it highly predictive of human clinical outcomes. Importantly, in both preclinical studies undertaken, NYX-PCSK9i has been well tolerated with no adverse effects observed. This development work follows on from an earlier cell-based study where we reported NYX-PCSK9i matched the efficacy of the two FDA-approved monoclonal PCSK9 antibody drugs in protecting LDL receptors from degradation, caused by PCSK9. These receptors are important as their function is to remove cholesterol from the bloodstream. The two drugs evaluated in the comparison study, alirocumab (Praluent®, Sanofi/Regeneron) and evolocumab (Repatha®, Amgen), are “injectables” that are prescribed alongside statins for patients who are unable to effectively lower their cholesterol levels using statins alone. Following a comprehensive medicinal chemistry program where multiple promising analogues were optimised and evaluated, Nyrada selected NYX-PCSK9i to progress to safety pharmacology and toxicology studies, before moving into a Phase I first-in-human study in mid-2022. “In an in vivo study, NYX-PCSK9i was shown to reduce total cholesterol by 46%when administered on its own and by a further 65% when given in combination with a statin. Pleasingly, NYX-PCSK9i outperformed the statin drug Lipitor® in the same study, which reduced total cholesterol by 27%.”