November 27, 2023
Bad News for KX-826 Phase 3 Trial Results
According to this Reddit source, the results of the Chinese Phase 3 trials for KX-826 (aka Pyrilutamide) were ok, but not good enough. There were no serious adverse events or side effects, and positive hair growth compared to baseline (at all visit points) after 24 weeks. However, compared with the placebo group, the total area hair count (TAHC) improvement in the KX-826 treated group had no statistical significance. Albeit there was a “trend in efficacy observed”.
On a positive note, Kintor plans to continue with its multiple KX-826 related trials (in the US and China) for the topical treatment of androgenetic alopecia. Moreover, I appreciate the speed with which the company released these findings. I expect there will be an official press release in the next few days.
November 18, 2023
Kintor Pharma: KX-826 and GT20029 for Androgenetic Alopecia
My original post on Kintor Pharmaceutical (China) has become way too lengthy after so many regular updates. So I will now add all new developments here. This rapidly moving well funded company is in Phase 2 and Phase 3 trials in the US and China for both its two androgenetic alopecia (AGA) products.
Kintor (pipeline here) is conducting hair loss trials for:
- Two separate androgen receptor (AR) targeting products: a degrader (GT20029) and an antagonist (KX-826 aka Pyrilutamide).
- Each of these trials is being conducted in both China and the US.
- Each of these products is being tested for both males and females with androgenetic alopecia (aka pattern hair loss).
i.e., a total of 8 types of clinical trials times 3 phases in each = 24 developments we have to track. A bit too much if all of these do end up taking place, but a most welcome development. Over one-half of these 24 potential trials are already finished.
- The GT20029 product is an androgen receptor degrader (AR Degrader). It is developed using Kintor’s proprietary Proteolysis Targeting Chimera (PROTAC) platform. This is the world’s first topical androgen receptor (AR) compound (AR-PROTAC) to enter clinical trials. GT20029 degrades the AR protein via the E3 ubiquitin ligase pathway. During preclinical studies, GT20029 did not cause any notable side effects or systemic drug accumulation.
- Kintor’s main product for treating male pattern hair loss is KX-826 (Pyrilutamide) and is an androgen receptor antagonist (AR Antagonist). KX-826 is currently in Phase 3 clinical trials in both China and the US per the pipeline chart. In China, these trials are done (see my new update further below).
Note that Cassiopea’s Breezula (Clascoterone) is an AR antagonist that is also currently in Phase 3 trials in the US. Kintor’s website has an interesting article discussing both these competing AR antagonist products and hair loss.
Make sure to also read my related past post on destroying the androgen receptor to reverse hair loss.
Phase 3 Trials for KX-826 (Pyrilutamide)
KX-826 (Pyrilutamide) is currently in the most advanced stage and has a good chance of coming to market in China by the end of 2024. In Kintor’s pipeline page, it is shown to be in the final stage of Phase 3 trials for men in China; and early stage of Phase 3 trials for men in the US. Moreover, it is also in the early stage of Phase 3 trials for women in China.
Kintor is also undertaking a second Phase 3 trial in China for long-term safety of KX-826, which I discussed in detail in my original post. Even more exciting, one my Chinese readers sent me the below partial translation of a new October 2023 presentation by Kintor. He said that his English is not good, but I only changed a few words that were confusing or out of place.
”
KX-826 is a topical androgen receptor (AR) antagonist independently developed by Pioneer Pharmaceutical. It is the first AR antagonist in the world to enter phase III clinical trials for the treatment of hair loss. KX-826 binds the AR by competing with dihydrotestosterone (DHT) to locally block androgen-mediated signaling to limit hair follicle miniaturization and promote peripheral hair growth. After reaching the circulatory system, KX-826 is rapidly metabolized into inactivated metabolites, which has little influence on the whole body AR signaling pathway and has good safety.
The Phase II clinical trial in China included 120 men with hair loss. Of these, 90 subjects were randomly assigned to KX-826 0.25% twice daily, KX-826 0.5% once daily, and KX-826 0.5%, and the remaining 30 subjects were randomly assigned to placebo. After 24 weeks of treatment, the 0.5% concentration group of KX-826 showed a significant improvement in the amount of non-vellus hair in the target area. An increase of 22.73 roots per square centimeter compared to baseline.
Finally, news about Phase III: KX-826 is currently in or planned for five Phase III clinical trials (two in China and three in the United States). Among them, the Chinese Phase III clinical trial of KX-826 for male alopecia has completed the last subject visit, and the company is making full efforts to promote the data collation, library un-blinding and data statistical analysis of this clinical trial.
“
Phase 2 Trials for GT2009
In Kintor’s August 22, 2023 update, they announced the completion of patient enrollment in Phase II clinical trials of GT20029 for male pattern hair loss in China. The current pipeline shows that these trials are almost over in China, and close to beginning in the US.
In the middle the post, I have linked to the October 2023 Chinese presentation image that someone from China sent me. This Chinese correspondent attempted to translate it, but feel free to check for any errors if you know Chinese.
Great work, admin. I’m sure this took quite a bit of time. I appreciate it. I guess we’ll see how it goes from here.
Nothing will happen.
You’re probably didn’t and honestly, from what I’ve seen leaked (if true and could be way off) much of this is as good as minox. I’m getting a little tired of stuff that claims it’s as good as minox. We need better. Way better.
I ordered Pyrilutamide on the grey market, and got some pretty shite sides. I’m hoping the real deal won’t feel like that, as I can’t handle fin.
Note that beezula is a mild fail since it didnt work longterm in the 12months study. The efficacy decreased significantly indiecating that this trend will continue over a year and patients end up under baseline nevertheless.
So breezula is trash and kx need to shownit works long term.
Admin – are you expecting KX-826 to be available in the US market by end of 2024? Or just Chinese?
Great question.
Just Chinese approval (best case scenario, assuming Phase 3 results are good). But it is so easy to get drugs from China these days.
Btw Dutasteride is still only approved in South Korea and Japan for hair loss.
Why would someone use this vs fin/dut? As a stack? What’s the difference between an androgen blocker, degrader, and antagonist?
Like others have said, if it’s as good a minoxidil and finasteride, then I see no reason why would you change drugs. Let alone add more to the inconvenience of topical application rather than oral.
Given how strong androgenetic alopecia is we need all of them. Stopping the convertion T/DHT (Dutasteride/Fin) is the most critical step but blocking (KX-826) and degrading the AR (GT20029) will be crucial for achieving long term success (20+ years).
That approach will be a true game changer for the young starting early enough.
Probably just for people who can’t handle Fin or Dut.
I’m more interested in the AR degrader product. If it works as it’s theoretically claimed, the results could be very significant. Rigorous safety studies are essential though !
https://www.wionews.com/science/scientists-achieve-major-leap-forward-to-potential-hair-loss-cure-660474
Wow, now that is huge. Long term, of course (maybe not in my lifetime) , but amazing nonetheless.
100% I agree with you, minimum 40 years (if we’re being generous).
What’s the point then. Why care if there isn’t a cure coming soon?
You must be new in the forum ;-)
I was being cynical Alex.
Does anyone have any information from stemson therapeutics? What are they doing? It’s been awhile.
Hope you have a good thanksgiving admin and everyone. (if you live in the U.S) and Yoda :). Take care.
Thanks and you too!
kintor released new news today, kx826 is hopeless, and its stock price has plummeted. I couldn’t cry or laugh when I heard the news. I was numb.
Thanks. There is some discussion about this on Reddit, but nothing on their site.
Sounds bad, though at least they released the results super fast.
https://www.reddit.com/r/tressless/comments/184pdh7/kintor_has_released_an_investor_relations_memo/
The last hope for a short term new product is breezula… After that, no new meaningful treatment until… 2030.
Kintor released the press release overnight (US time).
https://www.marketscreener.com/quote/stock/KINTOR-PHARMACEUTICAL-LIM-111325374/news/Kintor-Pharmaceutical-Limited-Announces-Results-of-Phase-III-Clinical-Trial-of-KX-826-Topline-Treatm-45442274/
I initially had high hopes for them until the Phase II results disappointed. I wish they would just drop KX826 and focus all their hairloss energies and resources on GT20029.
Thanks. They have enough resources, so hopefully no cannibalization of time and staff across so many trials.
Tough day.
Well I still can’t see official news on their website, but one has to assume the information is legit. I was wrong and initially thought the posts are doomerism and pessimism yet again…well alright.
Here we are, the one possible future product with the least efficacy (see phase 2) is gone down the drain. I personally wouldn’t have bought it anyhow, application twice daily for a dozen of hair is not worth it for me.
It makes no difference guys. We need treatments which are better than anything on the market now. Looking forward to Q1 when they release GT-results. I also think the company needs a homerun, there’s too many failed products already (see Covid-medicine) – otherwise they’re gone.
Make sense Ben. I deleted your short comment (as you probably guessed), but I would have thought the same in your place.
I had the advantage of being able to see that reader’s email address (a Chinese one) and his past one other comment on this site, so decided to check Reddit before concluding anything.
Totally fine with the deletion as I was in the wrong.
There’s been these absolute pessimistic and annoying comments lately from the known trolls which I want to counter (sometimes), and I shot from the hip in this case.
Let’s try to keep an optimistic view, as hard as it is sometimes.
This completely explains why they started the long term 52 week phase 3 trial this past summer. They saw that the efficacy wasn’t great but trending in the right direction, and they’re hoping a longer trial period will show a clear divergence in results vs placebo.
This also explains how breezula has designed their phase 3 trials, as they’ve had similar issues with their results.
The overall consensus on topical androgen antagonists is that they work, but not as good as 5a inhibitors. Therefore, they’ll need more time to show results which I think is worth it. This could still replace 5a inhibitors or stacked with it for more total efficacy.
I hope they commercialize this asap, and not wait for their long term phase 3 study.
Great point Johnny, and hope that is the reason!
Good post. Hope youre right as we need more weapons to the arsenal. AGA is a pretty strong beast.
No, breezula actually lost efficacy after 6 months with a decline to 9 months and was barley above basline at 12 months. When this trend continues breezula is trash.
For kx i dont know how 3 trials male and females has showed efficacy and now all of a sudden the point changed. Its interesting neverless if the product is trash or the trial design or maybe even the data analisis.
Phase 2 gt20029 is a pivotal moment for the company otherwise it may say good bye.
Yes, we’re aware of breezula’s declining results for months 9 and 12. If you look at their phase 3 design, they’re taking only those that were on the actual drug after 6 months and testing them vs placebo for an additional 6 months. It seems that their goal is to show that even though the results don’t hold long term, it’s still gives you more hair than you would have without the drug.
Not every new hair loss drug is going to be as efficacious as finasteride. It’s a different MOA that will show clear benefits and will appeal to way more people because of its 0 side effect profile.
I had a feeling that Pyrilutamide wouldn’t be as amazing as advertised. Especially at this point since 1993, big interventions are needed for drastic improvement of hair, dermal papilla multiplication, hair cloning, Amplifica, GT20029 etc
Im really lost as to how the results can suddenly drop off a cliff…anyone?
Are we saying it’s a total dud?
That’s the thing. Phase 2 data showed this was comparable to finasteride. We haven’t seen the data yet for phase 3, but now they’re saying that it worked but it wasn’t much better than placebo.
Hard to draw any conclusions until they share the actual data and we can compare them to phase 2 results.
Is it fair to say that it’s also unlikely to be effective for maintenance?
I don’t think that’s fair to say at all. Without seeing the actual data, we’re just guessing. But if that memo is legit, it sounds like the company still believes in the efficacy of this drug, and that they’ll be able to show it with longer 52 week study, which they’ve already started.
But even based on this memo, it said they’ve observed positive hair counts versus baseline over 6 months. Most people who are balding and not taking any treatments for hair loss will gradually continue to lose hair or stay the same after 6 months. Rarely do they see increases in hair counts, so this drug seems to not only maintain hair but also regrow some.
It’s the under performing delta versus placebo that’s confusing.
I am not surprised at all. We need something that shows legit hair growth. Not anti androgen topicals etc. On to the next drug. Hopefully that Bayer drug with the monkeys will work….2040 will have cloning…in the meantime it’s the big 3 snd fue.
I get legit hair growth from Pyrilutamide. I have been on it for over a year and basically regrew my bald temples.
I saw that three netizens in the stock market called kintor, and they were the following responses: 1. “The other party said that there was a mistake in the operation calculation, and they will continue to find the cause and strive for listing next year” 2. “I just called and asked, and I was analyzing the data, but they all think that the result is unlikely to reverse, and there will be no further announcements.” 3. “Just hit, the possibility of re-listing is not big, basically declared failure”
alas！
what is a netizens?