The Unprecedented Phase 1 Results of ET-02 for the Treatment of Androgenic Alopecia

Last week, Eirion Therapeutics announced positive results for its first-in-man clinical trial of topical ET-02 in the treatment of androgenic alopecia. The drug was safe and well-tolerated, with unprecedented results being observed as early as 5 weeks.

Dermatology Times recently spoke with Jon Edelson, MD, CEO and President of Eirion. He shared groundbreaking insights into the therapeutic potential of ET-02, its mechanism of action, and how it aims to revolutionize the treatment landscape for hair loss.

Edelson: I'm Jon Edelson. I'm the Chairman, CEO, and President of Eirion Therapeutics and its founder. The company was founded in 2016 and we're very happy with the progress we've had since then, especially the results of our recent trial for ET-02 for first-in-human study of androgenic alopecia.

Dermatology Times: What safety and efficacy clinical points from the ET-02 trial do you feel are most important for dermatologists to know?

Edelson: Regarding safety, we studied safety extensively in the first-in-human trial. In fact,that was the primary purpose of the study was to look at that safety. So, we looked at clinical indications of safety, particularly looking at any sort of local skin reaction. We asked the investigators to consider things like stinging, itching, burning, erythema, [and] scaling. We saw none of that. Because it was being applied to the scalp, there was the potential that there was accidentally something we get into the eyes. So we also asked the investigators to observe if there was any ocular irritation during the course of the study. There was none of that. To further study safety, blood was taken during the study from the subjects and examined across a wide range of blood work, chemistries, blood count, and things like that. No clinically significant abnormalities were observed. And finally, they also did EKGs to make sure there was no impact to the heart or the function of the heart. So we were, in sum, extremely pleased with the results. There was no safety signal whatsoever, and it seemed very safe to proceed with this treatment. So, the second part of the study looked at efficacy. And although this wasn't the primary objective of the study, it turned out to be the most exciting part of the study, where we looked at the amount of hair growth that was achieved. This was actually a 4-week treatment regimen, and then the patients were brought back a week later to do further observations of hair growth. And what we found was that the amount of hair grown, and specifically non-vellus or normal hair, was about 6 times the amount seen in the placebo. So ET-02, it was a 5% solution, generated 6 times the amount of placebo. And when you consider how much that is on an absolute basis, we compared it to separate clinical trials of 5% minoxidil, which is considered by many the gold standard for topical treatment of androgenic alopecia. And we found that in 1 month of treatment, we actually exceeded the amount of hair growth that minoxidil saw in its trials after 4 months. So it was a really very impressive amount of hair growth. And in fact, I would say clinical trials don't typically even look at hair growth until 8 weeks or later, because it's not observable. So, for us to be able to see this in this brief period of time was extraordinary. And in fact, we had Dr Jerry Shapiro, who's a professor at New York University and is considered one of the top experts in the treatment of hair loss in the world. He reviewed our data in some detail, and he said to see this amount of growth in this short period of time was truly unprecedented. So we couldn't have been happier with the results.

Dermatology Times: Where do you see ET-02 fitting into the existing therapeutic landscape? What separates it from other androgenic alopecia treatments?

Edelson: We see it as being actually something completely new and in a whole new category to itself. As I think about the approaches to treating androgenic alopecia, I think there's basically, broadly speaking, 2 approaches currently. One is to look at the hair follicle itself in the microenvironment, supporting the hair follicle. And there are attempts to, in essence, stimulate that hair follicle to grow further hair. Minoxidil is probably a good example of something that's trying to stimulate the hair follicle microenvironment. The other approach, which is more recent, and there really aren't any approved products in this area, is thinking about the stem cell. The hair follicle stem cell is very interesting because it's considered to be the master control switch for hair growth. And so, it's logical to think, "Okay, is there something we can do at that level, which is sort of where it all begins, to impact hair growth?" And there are thoughts about stimulating that stem cell. Our approach is actually different in that we believe that stimulation, while it may indeed provide some effect, and we've seen that with minoxidil and other approaches, is not really addressing the primary problem in androgenic alopecia. We believe the primary problem is that as people age, some people develop a defect in their stem cell biology, and that defect causes the stem cell to actually stop working. We refer to it as being deactivated, and we believe we've identified what's happening in this process. And our drug, ET-02, is actually targeting a correction of the stem cell biology to bring it back to normal. So at a high level, we are not looking to stimulate either the stem cell or the hair follicle. We're looking simply to turn the hair follicle back to its normal functioning, and with that, we hope to allow the stem cell then to produce normal hair. And in theory, this would not only enable someone to be treated who has androgenic alopecia, but the drug could potentially also prevent this defect from acting to shut down the hair follicle stem cells. So we have hopes in the future to study not only the loss of hair, but the prevention of the loss of hair.

[Transcript has been edited for clarity.]