idiopathic pulmonary fibrosis

You can measure some disease outcome that you can treat.

So, you know, people have looked at fibrosis, idiopathic pulmonary fibrosis, because it's a death sentence.

If you're diagnosed with IPF, you know, there could be significant liver disease, you know, fibrotic disease, liver and other tissues.

These are things where people are saying, OK, Now we can see if this works because these are lethal conditions with ineffective treatments currently.

So that's where many of these approaches will be tested.

Yeah, no, there's no question.

And I've been fortunate in my career to be involved with two diseases, IPF being one and now bronchiectasis, where we finally broke through with effective therapy that we have to be approved.

And so I think the situation with bronchiectasis is akin to what we've seen with ILD to previous years with COPD, asthma, where there's a clinical focus, there's some science here.

And with the pace of medical discovery, I don't think there's any question that we're at the brink of really a number of new drugs, and a number of new approaches that are coming down the pike.

moving it into additional liver diseases, rare liver diseases, primary sclerosing, cholangitis is really attractive, things like that, where I think there's brick walls in front of the industry that we can break through.

IPF, you know, doing more in IPF.

Vizient has established an IPF model as well.

And then...

And then, you know, at VivoSim, we're basically at the tipping point for, you know, really fast growth with this in the liver tox services as well as we repurposed.

So the AI found the novel target and then the generative side of their platform drew the exact molecule to block it.

And it is now in a phase three trial called Genesis IPF3.

And this isn't a small safety check, right? They are enrolling 320 patients across 47 centers.

Yep, for a 52-week, double-blind, placebo-controlled trial.

And so I said to the guys on the board who had asked me, you know, after we executed that deal, If I'd like to come in, I said to them, you know, with pleasure, but we really need to do a bit of a pivot because even though the drug's been doing so well up until the early clinical studies, diseases that they were looking at are such big diseases.

And I said to them that a company of this size, given that you have such nice data in animal models of lung fibrosis, the company should be going after an idiopathic pulmonary fibrosis disease, or IPF, because it is, in my opinion, and the opinion of many KOLs that I speak to, an unmet need in that whilst there are a couple of drugs that are approved and on the market for IPF, these drugs are aimed at slowing the progression of the fibrosis in the lungs in this disease.

And We had this data in animals that suggested that our drug actually reverses the fibrosis.

And so by doing that, we get sort of access to what we see as an rare disease.

So they give you a little bit of help to get through those early clinical development milestones.

And so, you know, I got the board to sort of agree with me and we've started to pivot into that direction.

Now, that lead asset that you mentioned, which is VB0004 for idiopathic pulmonary fibrosis, for investors that aren't new to that story, what is IPF and why is there such a significant unmet need?

Yeah, great question.

A quick recap.

From idiopathic pulmonary fibrosis, or IPF, a progressive scarring of the lungs.

Bristol-Myers Squibb's Phase III aloft IPF trial tested admilpirant, an LPA1 antagonist, at 60 and 120 milligrams twice daily against placebo.

The primary endpoint was the change in forced vital capacity over 52 weeks.

a lung function measure of how much air a person can forcefully exhale.

BMS hasn't explained the split, and it doesn't by itself mean the lower dose works better.

The full data will have to account for it.

Syndax has stopped in IPF.

Um, we're gonna pivot the conversation to data, uh, from the week.

Uh, we're gonna start off in the IPF space where Bristol Myers Squibb had a drug, uh, I think it's called Admilparent, Admilparent.

Sorry about that.

Um, they had a successful phase three study, but maybe not so successful phase three, and there are some read-throughs to some other companies.

Um, so with that in mind, I think what I'll do is maybe I'll turn it over to, to Paul, uh, or Brian, whoever wants to lead off, uh, on the discussion on the IPF data.

Uh, I'm happy to kick it off and then, yeah, love to hear Skorney's view.

Um, I, uh...

So yeah, so maybe for context, Bristol reported data that, you know, they are a hundred percent, um, describing as positive and I think they're probably right that it's positive for them in terms of getting a drug likely approved and a drug that could be a big product, um, for their drug that is, uh, an LPA-one receptor antagonist for idiopathic pulmonary fibrosis.

Sure.

that originally are targeted to IPF or certain lung fibrosis, but interestingly, they rejuvenate also certain proteomics clocks, you know, so that's where we're at here.

Sure.

And then lastly, and you can choose to answer this question or not.

Yeah.

And they designed Rent-A-Certib for idiopathic pulmonary fibrosis, that lung scarring disease I mentioned at the start.

So to understand the gravity of what Insilico achieved, we really need to understand why traditional pharma has just failed so spectacularly at curing IPF.

Well, the attrition rate for fibrosis drugs in clinical trials is staggering.

I mean, it's just really high.

Yeah, they do their job and clock out.

Exactly.

But in IPF, that signaling pathway is broken.