The development program for at least one of the of the Gastroenterology CRO agents that I’m aware of was stop, which I’m not sure why. There’s not a very robust active pipeline right now. There’s one that I mention that- that’s on hold, but will come back for, two- two or three years from now. It’s pretty good.
I- I’m- I’m hoping that what we’ll be able to do is to get the indication expanded to palms and soles, because not having that in- indication is often a reason why insurance companies will deny [inaudible 00:16:16] cut and deny coverage. So my hope is that the FDA will realize that this is really, hyperhidrosis is really a quality of life thing, more than it is a medical, I mean it’s a medical disease, more than it is a physiological problem.
Nobody dies of hyperhidrosis. But you certainly can, affect your employment, your social relations, your- your friendships your- your daily life. And- and so what I would hope would be, that the FDA would eventually say, “Okay, the heck with all this gravimetric measurement. Let’s use a PRO only and see what we get.”
Betsey Zbyszynski :
The- the study that I mentioned that we did 120 patients in- in six months in my site alone, was a PRO study only. Now, it’s not going to get anybody a label change, but it’s going to get some good information on uses of this Gastroenterology CRO particular product on the palms, which is what- what we studied.
Yeah, I think [00:15:00] across the board in a lot of dermatology indications, PROs are being use more and more. I mean I’ve been in dermatology, almost 20 years now, and initially we didn’t h- use the quality of life forms. And now, more and more, it is being incorporated into protocols. I think people are realizing that these aren’t necessarily life-threatening diseases, but the quality of life of these people is- is very compromised.
I agree with you completely. The problem is that the FDA doesn’t agree with you or us, or anybody about this. And although, you’re absolutely right, is that most sponsors are- are using quality of life measures in their in their protocols, it doesn’t make it to the label. It doesn’t make it to the packaging, to the prescribing information package insert. The FDA doesn’t they probably look at it, but they don’t view that as a metric that is acceptable for registration.
Dr. David Pariser :
So that- that’s, that ends up being something that gets gets a publication or a poster or both, and- and gets, present from podiums and lectures but doesn’t make it to promotional promotional setting. Which you have to be on the label to do it, of course.
Yeah, that’s- that’s too bad. Especially, I know with psoriasis the suicide rate is high. I’m sure it’s something like that in hyperhidrosis too, with people with severe.
We don’t really know that statistic because nobody has ever done a study that’s asked for it.
We certainly, the Hyperhidrosis Society gets emails every week from people with hyperhidrosis who are contemplating suicide now, if they completed the suicide, they wouldn’t be sending emails. But so it- it’s- it’s a significant psychological issue, for sure.
For anything? Okay, we’re talking now, I’m- I’m going to skip out of hyperhidrosis and go to to psoriasis. Now you might think that there’s not a whole lot of need for treatment for psoriasis. We have 11 biologics for psoriasis. We have some JAK inhibitors that are currently in clinical trials. We have other agents that are oral, small molecule, and other biologics, in the treatment of it. Why, so why do I want to spend my 250 million dollars on that?
Betsey Zbyszynski :
Here’s what I want to do. And this could, this is applicable to atopic dermatitis too, but more so psoriasis. Some people who have psoriasis, really bad psoriasis, it goes away by itself. Why? Something happens that interrupts that inflammatory cascade, and the psoriasis goes away.
It may stay away for a long time, it may come right back, but it does go away. What if we could have a drug that would somehow do whatever it is the body’s doing, and shut it off and cure psoriasis? Okay?
You know maybe it’s just one of the biologics we have in some kind of megadose. Maybe it’s something new. But that’s my moonshot for n- number one moonshot. I have other shots that are going just into suborbital space, but that’s my biggest one.
Yeah. People wouldn’t have to keep coming back, I know the biologics work, which is great, but that’s forever, if they’re coming once a month, because they don’t want to go off it in fear that their psoriasis will come back.
That’s true. That’s the worst fear that people have with psoriasis. I had patient on one of the psoriasis clinical trials one time. It was one of the long-term trials, and the patient had been completely clear, 100% clear, for two years. And the guy came in one time and said, “Doc, the stuff isn’t working anymore.”
Dr. David Pariser :
I said, “What are you telling me? Do you remember when you use to have more than half your body with this on it? What are you talking about it isn’t working anymore?” and then I always tell him we always want you to have a little bit of the psoriasis, that way we know we’re not giving you too much medicine.”
Of course. Oh my gosh, of course. And I guess if they see just a little bit, to them, it’s it’s all your perception.
That’s going to, that little bit, and then what’s it going to be? Am- am I going to go back to that awful stage I use to be? [inaudible 00:22:08]
Thank you so much, Dr. Pariser. This has been a pleasure. I’ve certainly learn a lot more about hyperhidrosis and the current market, and I do hope that some of these studies and protocols that you’re working on will make it to the market, and will be successful.
That’s what we do. I- I us to say when a treat- because the hyperhidrosis patient has the worst quality of life of anything. And when you treat them depending on, this- this was a study that was done when you treat them with Botox, their DLQI, the change in their DLQI is greater than the change in the DLQI of anything else we do.
Now, I can’t say that anymore because the biologic for psoriasis also now do that much. But it use to be, and s- and still is, a great improvement in people’s quality of life.
Betsey Zbyszynski :
The US Food and Drug Administration (FDA) announced that Olumiant (baricitinib) has been approve for the treatment of adult patients with severe Alopecia Areata. When clinically teste, Olumiant, a Janus kinase (JAK) inhibitor, successfully regrew hair in patients with alopecia areata who had at least 50% scalp Hair Loss as measured by the Severity of Alopecia Tool for more than 6 months.
Olumiant is the first FDA-approve JAK inhibitor to treat adults with severe alopecia areata. The characteristic hair loss associated with this disease has a significant impact on the patient’s quality of life. Baricitinib is an oral therapy that is administered once daily. It is not recommended to use Olumiant concomitantly with other JAK inhibitors, potent immunosuppressants, or biologic immunomodulators.
Alopecia areata is a disease that causes non-scarringl hair loss and affects as many as 6.8 million people in the United States. Alopecia areata is a form of hair loss that can affect both men and women. This autoimmune condition occurs when the immune system mistakenly targets its hair follicles, resulting in hair loss. The course of treatment will vary depending on disease severity, but it is important to note that there is currently no cure for alopecia areata.
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