Botanix Pharmaceuticals (ASX:BOT) targeting skin disease


by Jessica Amir

Botanix Pharmaceuticals Limited (ASX:BOT) President, Vince Ippolito, talks about interim results from the company's BTX 1308 psoriasis phase 1b study and opportunities in global medical dermatology.

Jessica Amir: Thanks for tuning into the Finance News Network. I'm Jessica Amir with Botanix Pharmaceuticals (ASX:BOT) President, Vince Ippolito. Vince, thank you for coming, and welcome to Network.

Vince Ippolito: Yes, happy to be here. Thank you.

Jessica Amir: And you've just wrapped up your first roadshow with the company, but before we get into why you're here today, let's just pause on your background and a little bit about Botanix Pharmaceuticals (ASX:BOT), who they are.

Vince Ippolito: I've been in the pharmaceutical industry for almost 35 years, and the vast majority of that has been in medical dermatology. I started with a company called Novartis Pharmaceuticals (SWX:NOVN), where I actually kicked off their dermatology division, and launched some very big drugs at that company. After that I went to an emerging dermatology company in the United States called Medicis (NYSE:MRX), and we built that to the largest independent medical dermatology company in the US. We launched a huge acne drug there at Medicis called Solodyn, and at that time it generated more revenue than any dermatology product in the US. Later we sold that company to Valiant Pharmaceuticals for almost $2.4 billion. When I left there I went to another startup. And again, there we developed and commercialised another asset for atopic dermatitis, a non-steroidal product called Crisaborole. The brand name is Eucrisa today. As we were developing that company, we ended up being bought by Pfizer for $5.2 billion.

Jessica Amir: Wow.

Vince Ippolito: So it leaves me here today at Botanix (ASX:BOT), and I'm really happy to be part of the company. Botanix is a clinical, medical dermatology company focused on the area of Cannabinoids. And so our focus today is in dermatologic skin conditions, anti-infectives. We have four products in our pipeline today. Two of them in stage two, one of them, the lead asset is for acne, and the follow-on product is for atopic dermatitis. Our development assets are in psoriasis and anti-infectives.

Jessica Amir: You've out performed all of your peers some would say. In fact, year on year, your share price is up 44 per cent and largely that's fueled from your announcements this week. So if you wouldn't mind telling us Vince, about the clinical and commercial importance of what you've announced?

Vince Ippolito: The first two announcements that we put out, the first one, was really around a study that we did, a punch biopsy study in psoriatic patients. Dr Jim Krueger at Rockefeller University, analysed the work for us. And what he was able to show was, is that our unique formulation of Permetrex along with CBD, it operated as an anti-inflammatory and an immune modulating agent in psoriasis. And because Dr Krueger mapped so many genes, he was also to validate for us in our two clinical programs of atopic dermatitis and acne, that CBD and our Permetrex formulation was anti-inflammatory in those diseases as well. So that was really huge news validating our clinical platform as anti-inflammatory agent and immune modulating agent.

The second piece of news that we put out, was another study that was done, that looked at our anti-infective program that we had. And the anti-infective program showed that we were active against all gram positive bacterias. Namely, that we killed both Staph and MRSA, and not only that we quickly killed Staph and MRSA, but the bugs did not form any resistance against the bacteria. So Cannabinoid did not form any resistance. And so now we've validated through two clinical studies that, we're anti-inflammatory, we have anti-infective characteristics, and we're immune modulating in the diseases that we have.

So when we shared these data with our investors, obviously there was great excitement, because we've actually somewhat de-risked our clinical platform proving our mechanism of action.

Jessica Amir: So Vince, where do you really see is the biggest unmet need at the moment?

Vince Ippolito: Let's start with our lead program here in acne. So there's really been no new acne medications in the last 20 years. So the unmet need for me in the market place, is really to have something that's not only efficacious that can treat the inflammatory characteristics of acne, but something that's cosmetically elegant for patients. Because often times, these acne products cause actually more redness, and the patient gets worse before they get better in using these products. And so what we found with our Permetrex formulation, it's a very safe and easy product to use, and because Cannabinoid has been shown to be a safe product, patients can use this product without the unwanted side effects of using an acne product.

For atopic dermatitis, this is really a huge unmet need. So let's take the United States for example, there's 18 to 24 million sufferers of atopic dermatitis, and it's mostly characterised as a disease of children. So most children who get the disease, the vast majority of them present before the age of two. So they go on topical therapies to actually control their disease. Well, when you're that young, the biggest concern is, safety of the agents that are being used, because frontline it's the topical corticosteroids, and these products can't be used for a long time in children. So for us, if approved, our development program in atopic dermatitis brings the promise of potentially something that can be used long term continual, because of its safety profile.

Jessica Amir: And just lastly Vince, before we let you go, we know Botanix is a small Australian listed play, but with you joining the company it really changes things up. What's next?

Vince Ippolito: Yes. So first off, I believe that we have something really unique and novel here. And we're delivering into markets where there's really truly unmet needs. So the most important thing for us, is to do the robust clinical work that we're doing today, follow the FDA guidelines, and get these drugs really approved. The two lead assets, as I had mentioned, are programs in acne and atopic dermatitis, so those studies are ongoing right now in phase two. And so, the acne study should wrap up sometime towards the end of the third quarter here, and then the atopic dermatitis study should be completed sometime in the fourth quarter. So then data follows after that. So our two lead programs, investors could look at top line data of our phase two studies that are going on.

You know, I really believe about a year ago, if you asked if most major pharmaceuticals companies in the US were talking about CBD or Cannabinoid, I'd say the answer was probably, no, they weren't. But as we turn the corner into 2019 with all the excitement that's in the US, I think we're on the radar now in the US. And I have built many dermatology companies in the past, and I'm committed to building this one as well.

Jessica Amir: Wonderful. Well, congratulations Vince Ippolito on the fantastic results.

Vince Ippolito: Thank you.

Jessica Amir: Very exciting times.

Vince Ippolito: All right, thank you.


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