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James Mackay

James Mackay

Australian actor

Aug 5, 2026

3:26
What is actually happening inside the body during gout, and what does that familiar picture leave out?
3:33
Yeah.
3:33
So that's an excellent question.
3:35
So gout, honestly, is one of the most misunderstood, um, diseases that, uh, that exists.
3:42
As you said, people believe that it's caused by diet and, you know, that the, the only symptom is a, is a big swollen, um, red toe.
3:52
Um, [clears throat] could be further from the truth, to be honest.
3:55
So gout is caused by excess uric acid in the body, and that can be caused by one of two things.

13 MINS LATER

16:46
So in your experience, have you come across anything humbling, uh, or anything unexpected that changed how, uh, you thought about this disease, the patients, and in, and in general how the trials were designed?
13:26
If I'm a gout patient or someone I know is a gout patient, what does Crystallis bring to the table now that maybe wasn't previously available through standard of care? Let me talk a little bit
13:36
about the gout patient journey.
13:38
Or maybe even talk a little bit about gout as a disease.
13:41
The biology here is relatively simple.
13:43
Gout is caused by excess uric acid in the body.
13:47
That can result from either or both the overproduction of uric acid, which tends to be linked to diet, or the under excretion of uric acid.
13:56
And what's important is that 85 to 90% of patients that develop gout develop it because they can't excrete enough uric acid.

9 MINS LATER

22:36
So tell me about that.
5:19
So can you walk us through a little bit about this Mortlock cask that's in front of us?
5:25
Sure.
5:25
Well, this is from a fairly well-known and amongst expert's in the industry, very highly regarded distillery from Speyside called Mortland.
5:40
It's from Dufftown and it's very, very close by McAllen.
5:48
Very different style.
5:49
It has a famously dark meaty, almost umami spirit character to it.
6:01
So much so that its nickname is The Beast of Dovetown.

22 MINS LATER

28:06
this a peated from like the
4:37
Yeah
4:37
...
4:37
when, uh, when the system needs to call on it.
4:39
So they actually build more gas, but you use it less.
4:42
Okay? So that is part of our policy.
4:45
Um, it's also, um, LNG is the policy position.
4:49
As a country, we will use gas to power, we will use LNG.
6:12
There's awareness of the coming problem, but to move from that to actual implementation in time for us not to have a dip in the middle is, is I think the key concern.
TomHOST
2:43
And when you were originally launching or thinking about the idea of Crystallis, was there a specific gap in the market or unmet need that you felt strongly compelled to address? Talk us through, why did you and your co-founders go around setting the company up?
3:00
Yeah, sure.
3:01
So my final role at AstraZeneca was I led the business development team that acquired a company called Ardea Biosciences that was developing treatments for gout.
3:11
So that was my first introduction to gout as a disease and the lack of available therapies.
3:18
And I took over the CEO role of Ardea and we took a couple of URAP1 inhibitors through to approval in the US and Europe.
3:28
But there were some challenges with those molecules.
3:31
So when one of our co-founders, Novo Ventures, approached me, they were the lead investor in my previous biotech that I founded, Aristea Therapeutics.
TomHOST
8:11
If you just to look at the broader picture, how do you currently assess the gout treatment landscape? And where do you see some of the most significant unmet medical needs that are out there today that are in this space?
15:40
How did that experience, both the scientific success and the subsequent commercial withdrawal of the drug, shape your thinking about Crystalis?
15:50
Yeah, very much so.
15:51
Um, so, um, we, um, so as you said, we developed, uh, Xurampic.
15:57
We also developed fixed-dose combination with allopurinol, uh, Xurampic, which was called Dzalo, and got approval for both of those in the US and, and Europe.
16:08
Um, the challenge that we had with that molecule is that it had a renal tox liability, um, and, um, that turned out to be, um, somewhat challenging.
16:20
So when we sought approval for that molecule, we actually chose the lower dose level that we'd studied in the phase three clinical trials because we considered that the higher dose level, um, did not have an acceptable risk-benefit profile because of the renal toxicity.
16:38
Um, and I can talk more if you want about why we believe that molecule had that renal toxicity.

8 MINS LATER

24:33
Can y-you outline the study designs, who's being enrolled, the primary endpoints, and the duration or follow-up?
35:47
Uh, before we get into it, 'cause I wanna, I wanna start with, like, the administrator side of your business and what that role is, and for you just to give a little bit of an overview of that, 'cause I know you're looking for somebody, uh, right now in, in, in that position also as well, right?
35:59
Yeah.
35:59
So, um, just to give the big picture, I suppose we've achieved 40% year-on-year growth over the last couple of years.
36:07
So we are organically growing relatively quickly, and that's a great benefit to the business, but it also is a challenge from a capacity point of view.
36:17
And so we believe in kind of hiring ahead of the demand.
36:21
And so ultimately that's one thing that we're doing at the moment.
36:24
We're building the next team.
38:11
So, um, can you just talk to me a little bit about those stages, like the responsibilities of an administrator, um, and what, say, somebody coming in at a junior level might look like up against somebody that's maybe at stage five?

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