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TISSUE REPAIR LIMITED (TRP) - Revolutionizing Wound Healing: Co-founder & CEO Tony Charara on TR987® Clinical Trials and TGA-Approved TR Pro+™

August 14, 2024 • Andrew Musgrave

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What if a simple biological trick could revolutionize wound healing for the first time in 25 years? In our latest episode of ASX Briefs, we sit down with Tony Charara, the visionary co-founder and CEO of Tissue Repair Limited, to discuss this groundbreaking innovation. Tony introduces their lead drug candidate, TR987® , which is poised to transform the treatment of chronic wounds as it enters phase three clinical trials in the US and Australia. He explains how decoy yeast cells can accelerate the body’s natural healing processes, potentially making TR987®  the first approved drug in its category in a quarter-century.

But that's not all—Tony also sheds light on the recent TGA approval of TR Pro+™, , a post-procedure topical gel that's already creating buzz in over 200 clinics. Initially launched as a cosmetic, TR Pro+™,  has shown remarkable results in enhancing skin quality and speeding up recovery post-aesthetic procedures. With its new TGA listing, this product's potential applications have expanded dramatically, from treating acute wounds to addressing conditions like solar keratosis. Tune in to discover the innovative path Tissue Repair Limited is forging and the significant impact their solutions could have on healthcare.

Andrew Musgrave:

Welcome again to ASX Briefs, and today I'm joined by Tony Charara, the co-founder and CEO of Tissue Repair Limited, a company that's at the forefront of biotechnology with second generation wound healing agents. The company is currently advancing its phase three clinical program for its lead drug candidate, , for chronic wounds, and has recently achieved significant milestones with , a post-procedure topical gel. Tony, thanks for joining me today and welcome to the podcast

Tony Charara:

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Andrew Musgrave:

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Andrew Musgrave:

Okay, just to get things started, can you just give us a brief overview of Tissue Repair and its core focus areas?

Tony Charara:

Sure.

Tony Charara:

So Tissue Repair is a phase three biotechnology company, so I'm a co-founder of the company and it was originally some technology that came out of illicit entity and when we took it over we did a couple of phase two trials, got a great signal in its key indication, which is wound healing. . c

Tony Charara:

So we have a technology where we take a yeast cell, we take out all the proteins and the lipids and we expose that yeast cell inside an open wound and the body perceives it as a threat and you basically get accelerated wound healing as a result of the remodeling that occurs from that decoy cell, if you like occurs from that decoy cell, if you like. So it's a technology that's applicable to all wounds in any animal or human. And our first drug candidate is TR987, which will shortly go into phase three trials in about a month or so, and that's two phase three trials that are in the US and Australia, and I think I'd summarise the opportunity by saying we could be the first drug to be approved in a chronic wound indication in about 25 years. So that's a bit of a background.

Andrew Musgrave:

Okay, and with the TR987, as you say, it's going into phase three clinical trials. So can you share some more details of the trial design and what you hope to achieve with the study?

Tony Charara:

Sure. So our endpoint is an endpoint called complete wound and it's in a chronic wound that are venous leg ulcers. So I think at that trial there's two trials, so two phase three trials, one in Australia and one in the US, and we're essentially measuring the incidence of complete closure between a vehicle and an active group. Now most clinicians would say that you'd want to sort of detect a difference of about 10% which is sort of considered meaningfully efficacious. In our phase two data set we were showing around a 20% difference, adjusted difference in complete healing. So we're trying to mirror that delta that we achieved or that signal that we achieved in phase two and I don't think any drug or device has shown that in a phase three trial globally. So if we do get that kind of a delta, most clinicians would consider that sort of breakthrough efficacy if we can show that in an FDA drug trial.

Andrew Musgrave:

Okay, and you've also recently received TGA approval for the TR-PRO+. So how significant approval for the company and what does it mean for the commercialization of the product?

Tony Charara:

Yes. So look, we originally started. We started a small pilot commercialization with TR Pro Plus as a cosmetic and that was launched or laser ablation, and really tiny trial. We launched in Sydney and New South Wales and showing really great success. I think we're in about 200 clinics now. You can check our Instagram site called Tissue Repair Skin where you'll see a lot of the wrinkling testimonials from that product and both clinicians and consumers alike.

Tony Charara:

We're getting really amazing efficacy results from the use of the technology and not only better healing, but improved cosmosis or skin quality. Better healing, but improved um cosmosis or skin quality. So what we do is we create. You know the laser creates a wound and by um exposing that wound to another decoy pathogen, you essentially are stimulating more collagen, more fibrosis um and better skin regeneration and that shows up in better elastosis and and improved wr. So now that product was launched with not a lot of claims as a cosmetic and we recently got that product listed as a TGA-listed medicine with claims around accelerated healing.

Tony Charara:

But what that also means is that we can go after a whole other myriad of indications. So that's acute wounds, burns, post-biopsies, solar keratosis, which is an indication that's an affliction that affects maybe 300,000 Australians. So it sort of speaks to the breadth of applications that the technology can be applied to. But it allows us to do that in a way where we can market our data, show all our mechanism of action data, so that whole data dossier that we've assembled for our drug trial, which all goes to wound healing efficacy, we can use and educate clinicians around it and I also think it opens us up for pharmacy distribution. So pretty excited by that step and it allows us really to expand the breadth for the product.

Andrew Musgrave:

Okay, and at a more macro level, what's the market potential for both those products and how do you plan to capture the market share?

Tony Charara:

Yeah, look, wound healing is a massive market. You have estimates of anywhere from $20 billion to $50 billion globally. So I think we're considered an advanced wound therapy. So for chronic wounds, that market could be $2 to $5 billion and we're up against therapies that are $10,000 or $15,000 a course. So some of these wounds, a lot of them, consider it a silent academic. They're the cost to treat of some cancers and there hasn't been a whole lot of innovation in that space for decades really.

Tony Charara:

So for the drug products, so TR987, that indication is squarely focused on chronic wounds is a hard to heal wounds and anesthetic, therapy where we're really trying to put a therapy in market that's more efficient than some of the more expensive therapies out there but essentially has the same level of efficacy.

Tony Charara:

So for can you tell us about any strategic partnerships or collaborations the company has formed and how they are actually helping you advance the product pipeline. acute wounds, so that's anything that's not chronic, so that's an abrasion, a cut, a burn, anything post, an aesthetic, a cosmetic surgeon's procedure, if you like. That market is also massive too, and we think that market could be, you know, one to $5 billion, depending upon the estimates that you use. So so really there is a huge market potential and there there really isn't a lot of products that I think actually immunomodulate the wound. So I think our success is around really resetting the wound so that we're being accelerated healing and having a direct immune response. A lot of the technology out there these days is around like a particular type of device or a patch, and so, you know, putting a therapy in market that basically accelerates the immune response I think is exciting and it has a huge breadth and allows us really to tackle those breadth of indications. I think our challenge is working out how we can you know which particular indications we go after and when, so that we can focus our efforts given the company's limited resources.

Andrew Musgrave:

Okay, no-transcript.

Tony Charara:

Look off the back of the TGA approval. There are a number of discussions we're having with multiple partners . These are across aesthetics, they're across general wound healing, they're across community health, so residential care settings where people, you know there are a lot of chronic wounds or incidents of chronic or acute wounds and there are a bunch of partners in each of those spaces, mostly in Australia at this point in time. But a lot of the parties are global and so any successes we have with some partnership deals here we feel it's a springboard to, you know, accessing a global market through those potential partners. So they're all in discussions. I can't say you know we're in active discussions at the moment but I'm hopeful in the coming months we'll be able to announce a couple of these. And that's the company's real strategy is to try and leverage partner distribution in terms of having market access and we sort of focus on product development and data and science and clinical trials basically, which is really the company's core strengths.

Andrew Musgrave:

of the key milestones and developments?

Tony Charara:

And our phase three trial. So I think we're in it. When we're about 25% recruited that's two 300-patient trials and when we're 25% recruited there'll be an interim analysis of futility. So that'll be a marker of we're going and that trial recruitment period is about 18 months and really the big value catalyst for tissue repair is basically getting a phase three result and being able to achieve a drug label.

Tony Charara:

The big Tony value catalyst for tissue repair is basically getting a phase three result and being able to achieve a drug label and that's a massive outcome for a small company like us, particularly given the health economics of the drug and the market potential. So really the big value catalyst is that. I think we were surprised about TR Pro. As I said, we had 100% quarter-on-quarter sales growth in about 200 clinics and I think some near-term catalysts would be our ability to execute distribution partnership arrangements for that product and really leverage the experience we're having here. So sales growth, distribution partnerships, I think on that side I think will also be near-term value catalysts.

Andrew Musgrave:

Okay, tony. Well, thanks for your time today. It's been great to get an update on where the company's at, and we look forward to further updates from Tissue Repair in the upcoming months.

Tony Charara:

Great, really appreciate your time. Thanks a lot.

Andrew Musgrave:

That concludes this episode of ASX Briefs. Don't forget to subscribe and we look forward to catching you on our next episode.