Kintor Pharmaceutical KX-826 Phase 2 Results With Poster
The long awaited phase II results from Kintor’s KX-826 (pyrilutamide) study in males with androgenetic alopecia have surfaced online.
KX-826 Phase 2 Results Presentation
Several months ago in May, the 28th Annual Meeting of the Chinese Society of Dermatology was postponed from June to the beginning of September 2022. This was the acclaimed conference where Kintor Pharmaceutical’s highly anticipated phase 2 trial results of KX-826 in males with AGA would be released. According to a recent update by the Chinese Society of Dermatology, their 28th Annual Meeting was yet again postponed to a further date, this time indefinitely. However, it appears we will not have to wait for another rescheduling to see the details from Kintor’s phase 2 trial. Another conference listed on the CSD’s website “The 6th National Hair Academic Conference”, which brings together experts and scholars from the hair research field was scheduled to take place Aug 26-28th. There is an electronic poster section of the 6th NHAC’s website which displays interesting hair research reports – one of them being KX-826’s phase 2 results.
app.incongress.cn/EPoster/html/posterModelH5.html
The original poster was written completely in Chinese and needed to be translated to gain a more precise understanding. Thanks to the amazing service Yandex, I was able to translate the poster to the English language. A downloadable PDF version of the translated poster is also available.
KX-826 Phase 2 Data Results
The important statistical data results from Kintor’s KX-826 pyrilutamide phase 2 trial in males is:
- The trial comprised 120 male subjects with Norwood levels of 3V, 4, and 5.
- Cohorts included KX-826 2.5mg BID, 5mg QD, 5mg BID, and Placebo QD, BID.
- Primary endpoint was non-vellus target area hair count (TAHC) change from baseline to week 24.
- After 14 days of topical use, the blood concentration levels of KX-826 were 0.3 – 4.1 ng/ml, and its metabolite KX-982’s levels were 0.4 – 10.4 ng/ml.
- The incidence of adverse drug reactions was 16.1%, with the most common being pruritus or itchy skin. No serious adverse events or serious adverse drug reactions were reported.
- The most efficacious results were obtained in the group receiving 5mg of KX-826 BID (twice daily) which showed a 15.34 hair per cm² increase in TAHC above the placebo group, and a total increase of 22.73 hairs per cm² in TAHC compared to baseline.
These results will certainly be well received by the community of people seeking new treatments for hair loss and hair regrowth. Showing a 22 hair per cm² increase in non-vellus hair count, these results are easily comparable to past studies of oral finasteride. As a reminder, Kintor is also currently engaged in other KX-826 clinical trials, including a female phase 2 trial and male phase 3 trial in China, as well as a male phase 2 trial in the US.
Note: Interpretation of certain translated data is continuing to be improved as more information becomes available. I have also updated the poster to a clearer version which was translated and provided by a dedicated reader, thanks.
Special thanks to Mathis for helping to lead me to this news. Thanks to all who redistribute this important news for citing this article with link.
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Hi, I want to buy
Pharmaceutical KX-826
Thanks
Please I want to buy some
Please read through the comments then. This website does not sell KX-826.
So I bought and tried the min max version of pyri. Now as a disclaimer I had used fin and dut for 15 years and came off bc the sides were too much at the end. I’ve been off for 6 years now.
If I even try to use fin at .5mg nowadays I immediately get sides and feel like hell.
So I tried pyri for the hell of it, hoping it might work without sides. Day two the ball ache came back and I could feel all of the old sides I used to get from fin. I stopped immediately. I hope others are able to use it and not give them sides. Good luck!
What is next on the horizon that is going to treat hair loss without the anti androgen angle?
Thanks agakn
Keith, Technoderma is up there and Hope Medicine’s HMI-115
The most beautiful thing about this is:
After all this years with no real(with studies and all the fda bullshit) new treatments, we finally get to see results of a new treatment.
So, whats your opinion about those results admin?
I’m interested to find out more about what this Shengku disease is lol, as a medical student I’ve never heard of this disease before lol
Bread, I think the results look great on paper, I would use the word promising to describe, and I still think we need to see the drug hit the public before we know the entire story. But overall, I am pleased with this trial.
What is “Shenku disease”?
Is it official or some kind of leaked result
Right off the Chinese Society of Dermatology website (linked in the article) and now confirmed further by Kintor’s press release.
Is it available in Turkey
The real drug is not available anywhere. Maybe the gray market research chemicals being sold are available, you’d have to check the websites.
Not that much excited. After all those years we have medicine with similar results to finasteride
Yes but it works on a different pathway does it not? I’m sure in combination with fin you can achieve even better results.
But finasteride has serious side effects, KX-826 pyrilutamide has not.
Fin results without sides is huge.
@Vlmp: similar results to finasteride but (appearently) without its side effects! Doesn’t this sound like a huge step forward to you?? Still far from being an ultimate Solution, no doubt, but if confirmed this would call for celebration, by far!
Good find ! Any info about the response rate?
Can someone explain what the difference is between Kintor’s KX-826 and GT20029?
Do they expect that GT20029 will be an improvement and replacement for KX-826 or is it their intention that both will be used next to eachother in the future? (and if it is possible to use both)
The later is an Androgen receptor degrader. I’m no expert but I believe this means it would actually gradually remove the androgen receptors locally on the scalp, thus removing the negative effect of androgens which contribute to hairloss. Please someone correct me if this is wrong
The results are same with finasteride? Looks like there’s 15 hair per cm2 above placebo in 24 weeks. When i look to the phase 3 results of dutasteride 0.5 there is only 8 hair per cm2 above placebo. This means it is even better than dutasteride. Also without side effects.
Strange, where are you finding these trial results for Dutasteride .5mg? The study I found, which was a double blind placebo controlled 24week trial of Dutasteride vs Finasteride vs Placebo: the results were +24.9 haircount per cm2 above placebo at 24 weeks for .5mg. Furthermore, at a dose of 2.5mg Dutasteride the results were +27.83 hairs per cm2. So, dutasteride still takes the cake.
-On a side note, I started finasteride at 20 years of age, and now 27 I have been on Dutasteride .5mg for 3 years. Never had any side effects. Well, except a full head of hair.
https://pubmed.ncbi.nlm.nih.gov/20605255/
Phase 3 results of dutasteride 0.5 mg. It is approved in Korea and Japan.
I am happy that it worked for you 🙂 There may be different results in different studies. In medicine unfourtunately 2+2 isn’t always 4.
We are now in Sept, is there anything that is coming out this year?
Potentially Cosmerna, but that may come out early next year.
What mg of finasteride you using?
Great to hear it’s comparable to fin. Hopefully between fin and Phyralutimide people can find a preventive measure that works.
Also a small Verteporfin update. I saw that Dr Barghouthi has lined up a full transplant with Verteporfin to begin early September.
I also got to ask Dr Barghouthi for some insights into what can be done with Verteporfin beyond a normal hair transplant.
For example the re-punching of old extractions to improve doner area.
Or maybe extraction of miniaturized follicles on the top of the scalp to see how they grow back.
He seemed receptive to trialling either of these methods to see what works. However the problem is finding people and to a lesser extent getting the verteporfin.
Just wanted to mention incase anyone here would be willing to try either of the above and can work around the Drs needs for the trial check ups.
I can imagine quite a few people who have had transplants would love to see about turning the doner scars back into doner hairs. Or even just reduced appearance.
FT, can you give us your opinion on this and if their is any timeline?
Keith, the numbers look fantastic. I think the data is promising and we still 1) have to see how it affects people in the real world who begin using it regarding safety/sides and 2) timelines are always available on the https://folliclethought.com/ultimate-guide-to-hair-regeneration article. I imagine you’ve heard of it before. It’s not always perfectly up to date, but it should help someone have a good ballpark understanding.
Good news, nice scoop Joe!
FT your article is getting a lot of attention on Reddit
Thanks Big Kahuna, I appreciate it.
Shengku disease just means itchy skin lol, nothing to be concerned about.
YOU DIG WHAT I’M SAYING !! YAHOO 😀
Remember these are the results in Chinese men. The results in caucasians will with all likelihood be much worse
That’s helpful.
What makes you say that?
My comment is directed at Forward, just to be clear.
Sorry, I failed to notice this before.
What makes me say that is both the indirect and the direct scientific evidence about this subject.
What I mean by direct evidence is papers like this https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057731/ that have studied the disparities in AGA severity between ethnic groups as one their main research questions. Severity of AGA is very much a predictor of how well the treatments working through hormonal pathways will on average work on subjects. Here’s a quote from the study referring to earlier literature on this matter:
“There are racial as well as age-related differences in the incidence and pattern of hair loss in AGA, and both prevalence and severity of AGA were reported to be lower in Asian and black men than in Caucasians.”
I know this is just a one study, but you can take yourself to a confirmation detour by taking a look articles cited in the end of that quote, the articles they have cited and so on.
By indirect evidence I mean the data we have on response rates to existing drugs. For example, in the original finasteride studies in which subjects were mostly caucasian men (88 %), the number of subjects who regrew hair was 18 % after the first year and 36 % after the second year. By contrast, in this study https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.14719 using Korean men as subjects, improvement (which by their definition definitely included hair regrowth) was seen in 46,4 % in first year and 55,5 % in the second year. The improvements also continued as more time passed and after 5 years of treatment, the proportion of subjects that experienced improvement was a whopping 85,7 %. This is in stark contrast to FDA studies where even the number of men *maintaining* started to decline after first year and after 5 years, was down to a number of 67 %.
Even crazier improvement and maintenance rates have been seen in japanese men https://www.oatext.com/Long-term-(10-year)-efficacy-of-finasteride-in-523-Japanese-men-with-androgenetic-alopecia.php
In top of this, there is also a lot of anecdotal evidence. By now it is a kind of truism in many hair loss forums that what works in asian men does not necessarily have a good success rate in caucasians.
Hope this clarified 🙂
Forward,
That’s pretty interesting. I have definitely heard that MPB is more common amongst Caucasians than other races, so maybe it is logical to assume they won’t have as good a response. Being a white guy myself, maybe I’m biased because I’ve responded pretty well to the available treatments. I’ve always felt that maybe the reason why other races are less prone to patterned hair loss may help explain the root cause of the problem. Like, can’t we just find all the 90 year old guys with perfect Norwood ones and just find out what’s going on up there? Lol.
I’ve heard this argument before in relation to the fin 10 year results. I don’t think it holds any merit; my own results as a white guy tally up with the fin study. Also, it obviously does its job Very well; comparable to fin with a different mode of action; we can stack this if we want.
As someone who is not a medical expert, can I ask how exactly are the blood concentrations of 0,3-4,1 ng/ml (Pyrilutamide) and 0,3-10,1 ng/ml (metabolite) low? A typical reference range for total testosterone levels in men is 2,5 – 9,5 ng/ml, which means that for some individuals, the concentration of pyrilutamide in the blood could be higher than testosterone. Even in the less extreme case, if the binding affinity of pyrilutamide is as high as claimed, wouldn’t there be very significant AR competition happening in the systemic level?
What am I missing here? Some one help me out.
This has always concerned me too. Pyrilutamide is theoretically a very very strong ligand receptor antagonist. If this stuff goes systemic, even in small amounts, it could prove very unpleasant.
I agree, these numbers need further looking into. I hope the study is screening adequately for signs of androgen deficiency.
It seems somewhat worrying to me that perhaps some people will be unlucky and the drug and metabolite will absorb systemically to a higher degree than in others. Who knows exactly why this may be.
Anecdotally this would possibly fit with reports of people’s experiences with RU58841 online. Some are fine, some get side effects similar to finasteride.
I presume we would know if people had experienced these type of “finasteride-like” side effects in the study?
What’s the relative affinity of pyru Vs test for the relevant receptor?
Yeah if someone could explain this that would be great as i’m also confused about this when upon initial reading about pyraludimide it was said that it was not absorbed systemically? now to hear that it is absorbed at rate similiar to testosterone levels is a bit concerning.
I think whenever one is talking about a topical drug which one wants to be active primarily at the site if application and not elsewhere there are a couple of key factors:
Firstly one wants a really short half life, so that the drug is really only active at the site for a short time, then when it is absorbed it becomes something else which hopefully isn’t a problem. And that would be point number two. The primary metabolite of the drug is favourable and not problematic.
I think this is what kintor were hoping for. Short half life and hopefully non worrying metabolites.
However, that’s why we need studies, to know how this plays out in the real world. People are all different, and for some reason we end up with variation. Case in point the range in levels of pyrilutamide and its metabolite seem to vary quite alot.
Yet we can see no mention of classic anti androgen symptoms in the study report? But like the OP I cannot understand how if these levels equate to levels similar to testosterone in the serum, how over time they will not start to cause a problem. Unless it’s that the levels are at these peaks for only an hour or so, so that the overall drug burden of it binding to androgen receptors elsewhere around the body is quite low.?
An old slide: https://i.imgur.com/H5K41w9l.png
But results seem on par with oral duta.
And side effects are just “itchyness” probably from carrier.
So good news, hope it’s legit.
But yes we need more information about “low systemic exposure”
Big thanks to all of my patrons on Patreon https://www.patreon.com/FollicleThought Support is always appreciated and welcome!
This is big …. Very big news . The androgen receptor antagonist along with the androgen receptor degraded is essentially a cure ! GT WILL LEAD US HOME
https://www.icthealth.nl/nieuws/regeneratieve-geneeskunde-geeft-kalende-mannen-hoop/
Mane
Thanks Hope, interesting they say “The hair growth device is currently only being developed for young men, because it does not yet work for women with hair loss and older men.” What if a young man has more advanced hair loss than an older guy? In any event, looks like Yoda will have to lie about his age if I decide to take the plunge.
Interesting, Hope.
There is one shady thing in the article though. In their news letter, Mane Biotech stated that “100% of our test group stopped hair loss and initiated hair regrowth within 6 months of using our product.” In this article, they say that their test *person* (singular) grew a thicker hair.
So all this confidence about how their device works and bold claims about the effectiveness based on a sample of n=1? Oh man…
Hmm I do not know. maybe there is a mistake in the article? As far as I know they worked with 11 clinics to conduct the study. A test subject would be quite little.
It’s either a mistake or they are just referring to one particpant who in particular had such stellar results… I remember several people claimed in early 2020 on a big german hairloss forum to have signed up for tests, so I’d be surprised if they really would only have tested it on 1 person (I’m also not even sure of a product with that minimal testing would even legal to sell there)
Hope,
Hope that’s the case.
Does it work for men n not women
Gurvinder, this drug KX-826 should also work for women, it is being tested in China for women now and we should get the results sometime over the next several months.
Nice News Turn Bio
https://www.prnewswire.co.uk/news-releases/prominent-stanford-university-scientist-and-cellular-reprogramming-innovator-will-oversee-all-research-for-turn-bio-850617515.html
Thanks Hope. I am excited that turnbio will cure many skin conditions. I hope they accelerate the process.
Yesterday I asked them through their email if I could sign up for human trials when they will be doing them and they said they are still a long way from them but they have put me in their database!! Soo hopefully it will be a safe and positive treatment.
Thnks ft
I want more information about the serum concentrations of kx-826 aswell. Those concentrations are not benign…
Concerneduser—what do you mean with “not benign”? What studies I’ve shown they are?
Josh—-correction: what studies HAVE* shown they are.
Ampflica is currently raising 10 million euros. Studies for Scube3 probably only in several years. However, the company appears to have other hair loss drugs in the pipeline as well. Studies on this could start next year. Positive: There are more and more companies that are trying to find a solution for hair loss with completely different approaches and now also with a lot of money. This is very promising.
https://dot.la/potential-baldness-cure-2658114684.html
https://www.reddit.com/r/tressless/comments/vp409h/comment/ifar5u9/ Rassman talks about starting clinical trials late this year or early next year though? And he’s a part of Amplifica
they seem to have several products in the pipeline. One of them will probably soon enter the clinical phase. Scube3 but probably only in a few years. At least that’s what the CEO says
It’s now available: https://actifolic.com/product/pyrilutamide/
Wow. Has anyone seen any of the hair loss forums trialing this?
Some cool news in the Updates page https://folliclethought.com/updates/ Remember to bookmark it and check it a few times a week. 😉
Great news. Admin, the last patient in phase 3 was dosed in June as the trial will take 6 months plus 1 month follow up this means that the phase 3 trial should be fully completed by February. Is this correct?
If the last patient enrolled was in June then that sounds right to me Julian. Then there is the road of submitting data to the regulatory authorities.
Epibiotech has collaborated with humedix to further their program
Thanks Gurvinder
Mane Biotech with a new homepage
I just got some in the mail from UGL. Cant wait to try!
What is available to try? Sorry I must hav missed somethinh
Keith, I believe he is referring to buying a 3rd party manufacturer selling pyrilutamide for “research purposes”, but Bob will have to confirm for himself.
Hey guys, curious where I might find pyril for research purposes? Please let me know.
Keith, I don’t personally know. You might try a web search or anyone else can share a link if they know.
Anageninc
https://anageninc.com/product/pyrilutamide-kx-826/
I’m not advocating for this company. I used their RU solution for a while a few years back and it seemed to have an effect. Switched up my regime and discontinued as I’m not a big fan of using unapproved chemicals from China (or any country for that matter).
3 websites I know for sourcing Pyrilutamide are Actifolic (Europe only I think), Anageninc, and Minoxidilmax. I don’t know much about the trustworthiness of each of these suppliers though. Generally they say they test every batch for purity and they share the certificate of test, but it’s impossible to tell if they really actually did it.
Minoxidilmax has some interesting products and they appear to ship to the US again, they stopped for quite a while. I used their 15% minox over 10 years ago when Dr. Lee went out of business and I could no longer get Xandrox. I’ll say I lost ground, it wasn’t as effective. However, they’ve been around for years, must work for some as they survive on re-orders. It’s another company based overseas so hard to know if their products are 100% legit.
Hey FT, I was wondering if you would be able to update the “Ultimate Guide to Hair Regeneration 2022” and include SCUBE3 perhaps? Whenever you’re free
I could probably do this sometime YoYo, but Scube3 is a ways off from even being developed. I’ve heard multiple years before trials. Just FYI.
Dr Rassman who is involved with Amplifica has stated that they are looking to do clinical trials sometime within the year though? You might have to scroll a lit down https://www.reddit.com/r/tressless/comments/vp409h/this_looks_interesting_possibilities_for_the/
Scube3 is a new compound. Not going into trials now. It is Amplifica’s 3rd compound. Few years away. A different compound is the candidate for trials. I believe I mentioned this in this thread.
FT, thanks that does make more sense. Btw Nick they’re planning on doing clinical trials I in 2023, not launch the product for commercialisation.
Hey Admin!
Could you do an interview with Mane Biotech?
Their claims seems to be a bit striking but the reason that it’s a German company which has won lots of startup prices makes them interesting again.
They are planing a product launch early 2023.
Best regards
Nick
Nick, thanks. I know some people are interested in the device, and I did attempt to get some info previously, but no plans to interview Mane at this time.
stemson with two new employees. The team now consists of 24 employees. Wasn’t Stemson’s goal to have a team of 25 people? Think news could come soon
Yup Hope that is what they said, 25 employees was the goal.
So, what’s poised to come to Market next year, Mane Biotech and what else or is that it? Considering Kintor yet to finish up and release phase 3 data I’m guessing they will be 2024 until commercially available
Potentially this too – https://folliclethought.com/new-hair-growth-cosmeceutical-using-sirna-with-published-study-cosmerna/
New article within the next day or two.
Anyone try the minoxidil Max pyri pure topical?
Hey FT I don’t know whether you already have assistance on translation, but if you ever need to clarify some Chinese content I’m more than happy to help.
Yang, thanks so much for that offer. I hope to take you up on that in the future. You don’t happen to know anyone who can also translate Japanese do you?
No native speakers around at the moment, but I know people studying there. Should be alright for some short texts.
Hi
I’m bald, it’s hereditary. Do you have a prescription for my hair to grow back? If so, how can I order it because I live in Germany
[…] further insights into the drug’s trial performance. Head to the main page now to read further information about this exciting […]
[…] Pyrilutamide is a non-steroidal anti-androgen (NSAA) that blocks testosterone and DHT from binding to the AR. It does this by binding to AR receptors in the hair follicles, which prevents the effects of androgens on hair follicle miniaturization. […]