The WHS WOUNDSHARK 2024 INNOVATION AWARD: Therapeutic BREAKTHROUGH — Eluciderm’s SuperHealer™️ Journey

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Eluciderm, Inc. won the WHS WOUNDSHARK 2024 INNOVATION AWARD at the 2024 International Symposium for Advanced Wound Care (SAWC 2024) as recognition for the anticipated market impact of its groundbreaking ELU42, a first-of-its-kind, topically administered, small-molecule Wnt signaling pathway inhibitor. Inspired by seminal academic research done with superhealer mice, ELU42 is the lead molecule in Eluciderm’s pipeline of therapeutics aimed at a paradigm shift from simply managing patients’ wounds to truly healing them, with the ultimate goal of making everyone a superhealer. Eluciderm’s Executive Scientific Team: Dr. Daniel Holsworth, PhD, CEO; Dr. Sarika Saraswati, PhD, VP Molecular Biology; and Dr. John Delgado, MD, CMO. For more information, visit www.eluciderm.com.

Transcript:

Hello, this is Brian McCurdy with HMP Global at SAWC Spring in Orlando, Florida. I'm sitting here with Eluciderm, who just won the Wound Healing Society WoundShark Award 2024 Innovation Award. First of all, congratulations on winning the WHS WoundShark 2024 Award. 

Daniel Holsworth, PhD, RAC:
Thank you, Brian. We were very gratified to be recognized as maybe a new leader in regenerative medicine. We were really pleased that, based on the competition, which was companies worldwide with new innovative technologies, that we were chosen as to be, you know, maybe have the highest success for being a paradigm shift in wound healing, and we feel that we really are going to be offering the world a new technology where people can truly be healed rather than their wounds just be maintained.

McCurdy:
Dr. Holsworth, can you tell us about Eluciderm? 

Dr. Holsworth:
Well, Eluciderm is a pharmaceutical company that's focused on regenerative medicine. We're utilizing small molecules to treat open wounds, closed wounds of all types, as well as we have small molecules to treat dermatological diseases, inflammatory diseases, and also oncology.

McCurdy:
And Dr. Holsworth, what is the innovation? 

Dr. Holsworth:
The innovation is actually based off research from Dr. Saraswati, where she identified that Wnt inhibition is actually what's driving regeneration of tissue, as well as increasing the rate of healing, and it's actually very counterintuitive of what's known in the literature. So, that alone was innovative in just saying, you know what, actually we may need a molecule that inhibits a pathway rather than stimulates a pathway. So, what I did is I saw her work, and the compound she was using was considered a research tool. It's very good for research and to verify mechanisms, etc. But it's not a drug. My background is in synthetic organic and medicinal chemistry. I've worked in large pharma for several years, in biotech for years, generating drug candidates. So, when I saw this, it's like, actually we can transform this into a drug.

So, I developed a novel excipient, which, when combined with this small molecule, actually transforms its solubility. So, now we have a spray-on drug that's an 89% saline, so predominantly saline, innocuous. And what it does is it inhibits a stem cell developmental pathway that's responsible for all organ creation in the embryo. And, of course, skin is your largest organ. And the beauty of this, and this is what Sarika had shown back in 2016, is that the Wnt pathway is only activated upon injury to the skin, and it's only active transiently. But what that means is that this pathway really could truly be a master regulator of healing. And all we have to do is modulate pathway. We don't want to shut it off. We couldn't shut it off, I'm sure. But we just want to modulate that so that we steer the healing toward regeneration rather than fibrosis. 

And we've shown this in many animal studies. We have 1 case study in humans with diabetic foot ulcers with a patient basically closed their wounds in 15 days. And we've not observed any recurrence. And we feel that this is going to really set the stage for a breakthrough in wound healing. And it's about time for patients to feel that they can get their wounds healed. 

McCurdy:
Dr. Saraswati, what is the breakthrough? 

Sarika Saraswati, PhD:
So, to add to Dr. Holsworth's comment and the discovery, it's very humbling as a biologist that your discovery that you're studying in the basic research goes to this level, and we were studying a superhealer mice and the stem cells that were isolated from these mice, and we found that this Wnt inhibitory molecule is hugely, like 300- or 400-fold upregulated, and then we did like a decade of studies, like published papers and identified that Wnt inhibition is the key. You modulate and inhibit to a level where you have a little bit of activation, but it's not overactivated. And this pathway is actually an embryonic developmental pathway. So it is active during your baby is made, like your mother is carrying the baby, and they are developing, but it shuts off after you are an adult.

So, we discovered that in the superhealer mice that when if you they're the he's spontaneously, and we identified it's because of the Wnt inhibition, Wnt modulation, and we overexpressed, we did a lot of studies, but we couldn't get it further down to the clinic, and Dr. Holsworth actually contacted me and we teamed up, and he actually discovered a really novel excipient and the carrier molecule where we can dissolve this inhibitor, Wnt signaling inhibitor, which is a small molecule, and make it bioavailable. And we actually have shown the similar superhealer capabilities in the animal models. Like, we all are superhealers. We are tapping our own pathway when we are adult with this molecule. 

McCurdy:
And Dr. Delgado, what do you hope to achieve? 

John P. Delgado, MD, FAAFP:
Well, you know, this has been a tremendous journey for all of us, but the passion we share is that of healing and regeneration. And I'm a physician with a functional medicine background. We talk about root cause analysis and what makes for the injury. And so this work, where there's this discovery that within each one of us, each cell, has this capacity to generate again. And it's intrinsic, but the adaptive response of birth to the stress of life is to create this fibrotic scarring, which has then traditionally been referred to as healing. So, we're changing some of the definition of healing, because healing now can be a regenerative process rather than just a repair with scarring.

And to be able to achieve that with this team, where we have the top in the class for the biochemical breakdown and the biochemical discovery of the medicinals and the biology behind it, where we have that intrinsic superhealer with all of us, now we're looking forward to being able to show that clinically, with clinical studies. 

There's been a long-stated need for the past several years emphasized that we need a pharmaceutical, a medicine for wounds. And it's been reiterated by the FDA. It's been sought after. There's many, many therapeutics for wounds that are in conjunction, whether it's skin actual placement in the form of a graft or there's antibiotics in the form of an infection, or there's bandages when you have to cover. And the combination, including what would be biological is where you're actually stimulating some tissues. But what we've found is by sending a molecular signal, just a small molecule that Dr. Holsworth was able to make topically in the form of a spray-on that's portable, safe, effective, and extremely tolerant with respect to room temperature and the environment that we place it, that it's something that anyone can use anywhere at any time.

And so what we're going to be able to achieve in our clinical research studies, which we anticipate very much positive results next year in a phase 1 study, and we have world-class authorities working with us, that we're going to be able to show that, with a spray-on topical, we can actually close the wound, heal the wound, and regenerate that primal skin that we all had, that we were actually only given initially by our mothers, because we're not just closing the wound, we're actually getting that renewed skin growth. And so to be able to achieve that, we've been able to show in our animal models over 17 different large animal trials, showing that reproducibility with open wounds, with burns, with traumatic wounds. And so we're going to start with a diabetic foot ulcer, which is the hardest one, because our product is also bacteriostatic. It actually can affect the bacteria that infects the wound. So, it's going to inhibit that and actually regenerate and to actually heal at the same time. So, the results should be world-changing. 

I would like to say Dr. Holsworth has actually developed a whole set of other analogues because what had been happening is that people had been looking at a different part of the molecule. This medicine, the drugs in this class, have been used for cancer therapy. And so people were focusing on cancer, because it's the same large family of molecules. But now what we're showing is that, in fact, we can focus on a different part which makes it allowable to be topical, which has different kinetics, different pharmacology, that make it safer. And in that setting, the domain is wide open. We have developed 105 different molecules, 10% of which, at least so far, have been shown to have significant activity. We have the first molecule that's showing regeneration for elastic cartilage. We have a molecule that can be used for surgery that we anticipate very highly to demonstrate that it's going to not only reduce scarring, the fibrosis, but actually increase tensile strength by creating this basket weave of collagen, which creates this elasticity again. So imagine again, when you're not only having to reduce scar, but you get that elastic rejuvenated skin, and then lastly at the same time, preventing bacterial infections that would be primarily coming from the wound. So, that combination of scar reduction, tensile strength, elasticity, and the bacteriostasis will also be able to be used for general surgery, for all surgical procedures, in fact for any dermatologic invasive procedure.

So, the combination of our products is for open wounds, closed wounds, acute wounds, and chronic wounds. So, we really want to be able to buy our product, have it available to everybody, available to a situation of a wound anywhere, including in the battlefield, in the emergency room, or for that matter, treating a child at home with an injury that would otherwise be a scar.

But we're going to start where the heart is first. It's the greatest medical need, it's the greatest receptivity, and we anticipate getting breakthroughs. So I really, we all look forward to getting breakthrough designation. We hope to be able to achieve that. We're working with the FDA very strongly. We have anticipated positive results, and we're showing great receptivity in the field of people with a need, and we hope to be able to achieve that within the next year with our data coming through.

Dr. Holsworth, would you mind mentioning a little bit about our future pipeline of products? 

Dr. Holsworth :
Sure. Of course, we have ELU42, which we're right now in definitive toxicology and anticipated an IND by the end of the year. First for chronic wound treatment, but we also have ELU42 slated for a third-degree burn, as well as soft tissue traumatic wounds. We have a small molecule that what you'd mentioned earlier, John, is we have a topical to treat surgical wounds, and this drug not only improves cosmesis but also improves tensile strength. We have other drugs that improve cosmesis primarily, and so that would just be for plastic surgery for instance. There's no drug ever shown to regenerate elastic cartilage, and we show this topically applied substantially regenerates elastic cartilage, it’s actually phenomenal. And we anticipate that for facial surgeries, primarily the ears and nose. And we have a drug for psoriasis, small molecule for psoriasis.

These are not all Wnt inhibitors, but we have unique PARP inhibitors for various types of cancers. Again, we're trying to focus everything on topical, at least at the beginning, because it's just a safer way to introduce a drug. You have 100 % bioavailability when you apply topically, and we can manage the safety much more efficiently. 

We also are looking into acne. It may be surprising, but actually almost 100 % of the population will have an acne problem at one point in their life. And we are envisioning that as being actually a series of very small chronic wounds. So, can you envision reducing, you know, closing the acne, the open wound, closing that wound with reduced scar or no scar? And so we really feel that we have a very wide, a very large market, and there's a huge unmet medical need with all the indications that I mentioned. So, we see a bright future.

Dr. Delgado:
And I would like to mention as well that one of our goals and responsibilities I feel is when we're tapping into the wound and addressing wound healing at the cellular level, one of the objectives that we also have is to address with information that's going to be supplied as people look into our product line of what are the natural medicinals in the form of food and lifestyle and modifiable changes that we all can make to truly make a difference on wound healing. But the most beautiful thing, as Dr. Saraswati has said, is that the work comes from basic understanding of the molecular mechanisms on how we heal and things that have gone dormant, we can now reawaken. So, just like we were superhealers within our protective environment of the mother, we actually now have the ability with ELU42 and the Eluciderm products to become superhealers again, just by a topical spray-on that's available at any given place, at any given time, and for everyone. So, it's going to change, I think, the world of healing, and I'm looking forward to that. So, thank you for this opportunity, and we're very proud of the award. It's really representing, I think, the future of where we're going. 

McCurdy:
Well, this all sounds very promising. Thank you for being with us today, and congratulations on your award. And to learn more, you can visit eluciderm.com. Thank you for watching.