First Clinical Evaluation of the Safety and Efficacy of Tarumase for the Debridement of Venous Leg Ulcers

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Hi, my name is Hadar Lev-Tov and I'm an Associate Professor of Dermatology. I work at the University of Miami, Department of Dermatology and Cutaneous Surgery. I'm a dermatologist by training, but I also see a lot of patients with wounds in our wound center.
 
What inspired you and your team to take on this particular area of research?
 
I think we see a common problem in our wounds in which to prepare the wound bed, it's challenging. Patients come in and even after the best debridement that you do, they still have kind of slough on the wound and we can get that wound bed ready for healing or for advanced therapy. And it's not a new problem, it's been in existence since wounds exist and there's various ways to prepare the wound bed.

And in this particular project, the company that has produced this drug is really trying to take an old intervention and putting a modern spin on it that will allow us clinicians to use this in a reliable manner. And so in this particular project, the drug we're talking about leverages the advantage of using biologic debridement, namely larvae, which traditionally we know is very effective, works very fast, but it has some challenges, it can sometimes be a little painful, but more importantly, patients just don't like it. It has what I call the yuck factor. And so this company was able to take the relevant enzymes out of the secretion of these maggots and was able to then put it into a hydrogel, which is a delivery system that will go on the wound and help to prepare the wound bed. And so, in this particular study, we wanted to see how this will work in venous leg ulcers.¹
 
How did you conduct this research and what did you find?
 
This study was designed to really answer the needs of regulatory agencies, so we're talking about a drug, not a device, so I think it's key to remember that a lot of times, in wounds we tend to talk about devices, so the standards are much higher, if you will. And this was a single arm study with different sites in which patients were assigned to receive escalated doses of this medication.
 
And the goal really, this is kind of first in human studies, so the goal was really safety. tolerability, and to see as we elevate the doses if there's no significant adverse event, both locally—so in the wound, around the wound, to the skin—as well as systemically. The wounds is open and there's some level of absorbency, so you want to see what is happening in the blood. So those were the kind of outcomes we look at.
 
Of course, as clinicians, we always keep about wound healing, but we can't get ahead of ourselves. So, this will be tested in a later study, but I'll tell you that we also looked at that as well.
 
What do you most want clinicians to know about this drug?
 
What we found in the study is really early encouraging signs. So, first we found that it was very well tolerated, there were no significant side effects. I think a lot of these products that are on the market for wound bed preparation can sometimes be painful, so we didn't see any signal for pain, which was good.
 
We didn't see any relevant systemic symptoms, so you know, you put in an enzyme that can chop away protein, so you're worried, oh, is it going to lyse something else that we need, like our blood cells, for example, or stuff like that, so we didn't see any of that signal there, which was very reassuring. We found also that it tends to work, but for we saw mostly in the higher doses.
 
And so I think now the challenge will be to take it to the next level and try to treat it to slightly higher doses and start looking at the wound bed preparation. But anecdotally, we already saw some promising results. And this was very similar, the results we saw in humans to the results we saw in an animal model when this was done in the preclinical.
 
So I'm really excited about that and I want my colleagues to know that there's hope. This is coming down the pipeline. It's still early stages, just a phase 1 study. But I hope that the company will get enough funds to run the next study, the next study, to get all the way to phase 3 and to your bedside very quickly. This will certainly add an important tool to our toolbox for wound bed preparation that hopefully will be effective without pain, readily used by our patients so they can get better outcomes and get the wound bed so we can either heal the wound or use advanced therapies as we like to do.

Disclosure: Dr. Lev-Tov is a consultant for SolasCure.

Reference

1. Szepeshazi K, Fairlamb D, Goldsmith D, Danos P, Hanft J,Young N, Zelen C. First Clinical Evaluation of the Safety and Efficacy of Tarumase for the Debridement of Venous Leg Ulcers. Poster presented at SAWC Spring, May 2024, Orlando, FL.