Nyrada Limited (ASX:NYR) CEO James Bonnar discusses the cholesterol-lowering market, and recent results for the company's lead drug candidate, which achieved a 57% reduction in total cholesterol.
Rachael Jones: Hello. I'm Rachael Jones for the Finance News Network. Joining me today from Nyrada (ASX:NYR) is CEO James Bonnar. James, welcome back to the network.
James Bonnar: Hello, Rachael. It's good to speak with you again.
Rachael Jones: Good to see you again. Now, to the first question, 2020 was a big year for Nyrada. Can you tell us about this first year of operation?
James Bonnar: It was a landmark year for Nyrada. We listed in January, had a very successful IPO, and we've made significant progress on the two lead programs, the cholesterol-lowering program and the brain injury program. In March, we had to readjust to life under COVID. We managed to do that successfully and put in place measures to account for that, and operations were only minimally affected. We wanted to close the year on a really high note, and we achieved that with the impressive results that we released just before Christmas. And these are concerning our cholesterol-lowering program.
Rachael Jones: Now, could you describe to the viewers about the cholesterol-lowering market?
James Bonnar: Sure. So the cholesterol-lowering market is very large, and it's dominated by statins. And just to give you some context around that, the statin market is worth around about US$19 billion per year. And if we look at the two leading statin drugs, Crestor, an AstraZeneca drug and Lipitor, a Pfizer drug, they account for a large percentage of prescriptions here in Australia. In fact, last year they were ranked the number one and number two most prescribed drug. So statins, in terms of numbers, in Australia here about three million patients take statins regularly and that includes about 40 per cent of people over 65.
Rachael Jones: And what benefits will the Nyrada drug provide to patients?
James Bonnar: With statins, there's a suboptimal effect in a majority of patients. In fact, recent studies have shown that that affects as much as 70 per cent of patients. So, these are people who, despite taking a statin, are unable to reach their target cholesterol level. And so that leaves them at risk for cardiovascular disease. That 70 per cent also includes about 15 per cent of patients who are statin-intolerant. So, currently, these patients are either undertreated or not treated at all. So Nyrada is developing an affordable, effective and convenient treatment to enable those 70 per cent of patients who are currently underserved to reach their target cholesterol level.
Rachael Jones: Now, back to Nyrada's recent announcement, can you tell us about the 57 per cent reduction in total cholesterol and why these results are important?
James Bonnar: The results that you can see are from a recent study we performed in a mouse model, and this is a specialised model where these mice mimic human cholesterol metabolism and health outcomes.
And what's particularly interesting or important about that is that it provides a good predictor of what we can expect to see when we dose humans. And, from the graph, you'll see that the two doses we tested, there was a consistent reduction in a dose response, meaning that the more we gave, the more effect we saw. And that continued out to 28 days or four weeks.
So, in terms of the magnitude of effect at the top dose, we achieved a 57 per cent reduction, which was beyond what we expected. It was a really strong result. And to put that in context, in historical studies of the lead drugs on the market, Lipitor, that achieved in the same model a 20 to 50 per cent reduction, depending on the dose. The injectable monoclonal Praluent, a Sanofi Regeneron drug, it achieved between 36 and 47 per cent reduction in the same model. So, as you can see, the results for our drug are very impressive. What's also pleasing to see is that, over the 28 days of the study, the drug was well tolerated.
Rachael Jones: Excellent. And lastly, James, what can Nyrada shareholders look forward to over the next six to 12 months?
James Bonnar: Well, we have some further exploratory analysis that we're currently undertaking, and that really talks to the safety of the drug in this study, and we'll be announcing that data in the coming weeks. The other thing that we're working on is preparations for taking this molecule into the pre-clinical safety testing that is needed to be done before you can dose a drug first in human. What we're planning longer term for this program, we're looking to get this drug into the clinic, have it ready for the clinic by the end of the year. And we'll be doing a phase one healthy volunteer study here in Australia.
One of the things I'll point out about Nyrada is that we are a discovery and early stage development company. So we're looking to commercialise this program at the end of phase one, when we've confirmed safety and whether the drug works. What's interesting about that approach, that strategy is that we're dealing with much shorter timeframes than typically biotech companies would, and we're also dealing with programs that have lower capital requirements.
Rachael Jones: James Bonnar, thanks so much for joining me today, and thank you for the update.
James Bonnar: Thank you, Rachael. It's been a pleasure.