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- Results from a preclinical trial of Nyrada’s (NYR) molecule, PCSK9i, show it’s more effective at reducing cholesterol than the world’s best-selling drug
- In the mouse model trial, Lipitor — the most-prescribed drug in Australia — reduced cholesterol by 27 per cent over five weeks
- Nyrada’s drug candidate, however, reduced cholesterol by 46 per cent when used as a monotherapy, and 65 per cent when used in combination with Lipitor
- The preclinical, drug development company plans to report follow-up analysis next month and is preparing for a first-in-human trial to begin mid-2022
- Shares closed at 29 cents on June 28, 2021
Results from a preclinical trial of Nyrada’s (NYR) molecule, PCSK9i, have shown it to be more effective at reducing cholesterol than the world’s best-selling drug.
The trial in mice tested Nyrada’s drug candidate against and in combination with Pfizer’s cholesterol-lowering drug Lipitor. First approved by the US Food and Drug Administration in 1996, Lipitor’s patent expired in 2011 and it has since been sold under the name ‘atorvastatin’.
In the 2020 financial year, it was also the most prescribed drug in Australia, according to data published in the peer-reviewed journal Australian Prescriber.
Study results
Results from the in vivo efficacy study, showed over a five-week period Lipitor, or atorvastatin, reduced total cholesterol by 27 per cent.
Nyrada’s molecule PCSK9i, however, lowered cholesterol by 46 per cent when used as a monotherapy, and 65 per cent when used in combination with Lipitor.
The drug candidate works by increasing the number of LDLR receptors, which bind to LDL particles — often referred to as ‘bad-cholesterol’— reducing their levels in the blood.
Build-up of these particles on the artery walls can lead to a heart attack or stroke, the imperative behind medical interventions to counter heightened levels of LDL in the blood.
Nyrada CEO James Bonnar said the results bolster the company’s confidence that the molecule is the best drug candidate to progress to 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 per cent of patients at risk of cardiovascular disease who struggle to reach their target LDL cholesterol level despite taking a statin, such as Lipitor.”
What next?
Nyrada plans to report follow-up analysis of the in-vivo trial in July. The preclinical drug development company is also preparing to carry out safety pharmacology and toxicity studies in the second half of 2021.
These will be completed ahead of a phase one first-in-human study which is expected to get underway in mid-2022.
Shares closed at 29 cents on June 28, 2021.
