Nyrada (ASX:NYR) has announced what it describes as "encouraging efficacy results" from a preclinical study of its NYX-PCSK9i in combination with a statin.
The company said its small molecule NYX-PCSK9i was studied with atorvastatin in an in vivo study in a specialised mouse model, called APOE*3-Leiden.
"The results support the selection of NYX-PCSK9i as the preferred compound for preclinical studies at an internationally recognised Contract Research Organisation, ahead of a Phase 1 first-in-human study," said the company.
The company said the mouse model showed NYX-PCSK9i reduced total cholesterol by 46 per cent as a monotherapy and 65 per cent when dosed in combination with the statin.
"In this study, a dose of 50mg/kg was administered and evaluated over 35 days (5 weeks) with no adverse effects identified. Pleasingly, NYX-PCSK9i was well-tolerated with no significant changes in food intake, body weight, or liver function observed," said the company.
Nyrada CEO James Bonnar said, “NYX-PCSK9i has shown very encouraging results in this recent cholesterol-lowering study, building our confidence it is the best drug candidate to take into human trials. To our knowledge, this is the first preclinical study showing a cholesterol-reducing effect from an oral PCSK9 inhibitor drug when dosed in combination with a statin, making it exciting new territory to pioneer.
"It has the potential to provide a convenient and cost-competitive oral therapy for the 70% of patients at risk of cardiovascular disease who struggle to reach their target LDL cholesterol level despite taking a statin, such as Lipitor [atorvastatin].”