Kintor has started Phase 3 trial in China for Pyrilutamide

[Adri23]

I was under the impression that Pyrilutamide was an androgen degrader. If so then its mode of action is far different than an anti-androgen like Breezula or RU. The safety profile would also be better.

Nahh the AR degrader is GT20029 and it is years away.

 

[trialAcc]

Allegedly, TAHC (Target area hair count) of pyrilutamide from the phase II study was 22.5/cm2 according to people who saw the leak. If true, and again that is a big if, these results are very encouraging.

Not to be that guy, but Breezula reported 20.7/cm2 increase at month 6 for their target dose as well. By month 12 it was 4.70/cm2 above base line, and I actually remember they did some weird reporting metric where the count was the difference from the control group, meaning that people were under baseline at 12 months on the top dose despite having an increase similar to KX at 6 months. Notice how every stack has a "significance vs baseline" star except for the 12 month?

Without a 12 month phase 3 these results are going to be pretty worthless. If I had to guess why they didn't do a 12 month phase 3, they probably saw a decease in hair counts towards the end of the trial.

 

[5minutesbeforemiracle]

just a friendly reminder that 6 months result of breezily was 21/cm^2 in TAHC. then after 12 months it went totally to sh*t. Kintor does not plan to do a 12 month phase 3 trial. they are both topical anti androgens and have a very comparable mechanism of action. so even if the leaked results were to be accurate and the side effect profile was to be favorable, who says that pyralutamide shares not the same property that it cannot maintain the regrowth for more than half a year. and we would never know because they do not have to do a 12 month trial. maybe they will have to do one for the FDA once they are in phase 3 in the US. but that will take another 1-2 years minimum

I still do not understand why breezula did so well initially and then so poorly when other anti androgens like finasteride or dutasteride really start to show the best results after 12-15 months. its strange because anti androgens take a long time to show their positive effects however with this one it seems to be potent initially and then diminish(breezula). personally I am hopeful that Pyrilutamide does not have this property

One difference though is that Pyrilutamide has a way higher binding affinity than breezula (breezula is super weak, like 30 times weaker than testosterone). So hopefully pyrilutamide can hold its results for longer.

 

[LoWS]

One difference though is that Pyrilutamide has a way higher binding affinity than breezula (breezula is super weak, like 30 times weaker than testosterone). So hopefully pyrilutamide can hold its results for longer.

Theoretically, can it show long term results (10+ yrs) like finasteride?

 

[trialAcc]

One difference though is that Pyrilutamide has a way higher binding affinity than breezula (breezula is super weak, like 30 times weaker than testosterone). So hopefully pyrilutamide can hold its results for longer.

Yes, that's why Breezula is dosed at 7.5% to compensate for it's weakness. Pyrilutamide can't be dosed higher because it goes systemic at even 1.5x the tested dose (12mg), so what you see is what you will get.

 

[5minutesbeforemiracle]

Theoretically, can it show long term results (10+ yrs) like finasteride?

Yes. However, for the next few years we will only know its 6 months efficacy.

 

[LoWS]

Yes, that's why Breezula is dosed at 7.5% to compensate for it's weakness. Pyrilutamide can't be dosed higher because it goes systemic at even 1.5x the tested dose (12mg), so what you see is what you will get.

So Kintor should not do a phase 3 trial of this drug in the US? It should focus more on the GT drug?

 

[trialAcc]

So Kintor should not do a phase 3 trial of this drug in the US? It should focus more on the GT drug?

No, they should and will. There's been nothing new on the market for 20+ years, they will do massive sales just on the hype and fact that it isn't likely to cause ED alone.

I'm happy to be proven wrong here but I just think there is enough evidence here to at least suggest they could have ran into similar issues to breezula and even RU in that these types of topicals are just not that effective. That hasn't stopped minoxidil 2% from selling hundreds of millions a year for decades despite doing almost nothing.

 

[LoWS]

No, they should and will. There's been nothing new on the market for 20+ years, they will do massive sales just on the hype and fact that it isn't likely to cause ED alone.

I'm happy to be proven wrong here but I just think there is enough evidence here to at least suggest they could have ran into similar issues to breezula and even RU in that these types of topicals are just not that effective. That hasn't stopped minoxidil 2% from selling hundreds of millions a year for decades despite doing almost nothing.

I saw in some thread there is a GB on kx , there results should atleast give us a hint of it's long term efficacy isn't it? By the end of the year we may have some data.

 

[fashy]

No, they should and will. There's been nothing new on the market for 20+ years, they will do massive sales just on the hype and fact that it isn't likely to cause ED alone.

I'm happy to be proven wrong here but I just think there is enough evidence here to at least suggest they could have ran into similar issues to breezula and even RU in that these types of topicals are just not that effective. That hasn't stopped minoxidil 2% from selling hundreds of millions a year for decades despite doing almost nothing.

I mean the only "evidence" is that they decided do a 6 months phase III trial in China instead of a 1 year one. It is a suspicious choice, but at the same time doesn't necessarily mean that it will not be up to par. Furthermore, with RU there have been reports of longer maintenance than 6 months for what it's worth and this should in theory be stronger than both Breezula and RU.

I think by the end of the year we will know, once all the GB have had ample time to test it out. Phase II results might also leave clues as to whether the effect diminishes as time goes on.

 

[trialAcc]

I mean the only "evidence" is that they decided do a 6 months phase III trial in China instead of a 1 year one. It is a suspicious choice, but at the same time doesn't necessarily mean that it will not be up to par. Furthermore, with RU there have been reports of longer maintenance than 6 months for what it's worth and this should in theory be stronger than both Breezula and RU.

I think by the end of the year we will know, once all the GB have had ample time to test it out. Phase II results might also leave clues as to whether the effect diminishes as time goes on.

What about the fact that you haven't seen any phase 2 results despite a phase 3 greenlit being almost over? Usually, when a company has top tier drug results they are screaming it at every publication who will listen, and that doubly goes for a company like Kintor who's stock dropped 80% due to a mishandled phase 3 trial around the same time that they had the phase 2 results ready to apply for phase 3.

Again, happy to be proven wrong, all I'm saying is to take whatever those results are with some skepticism. It will probably be a great addition for people with moderate hairloss, but it's probably not going to replace finasteride/dutasteride in guys with more advanced loss.

 

[Baldingtooyoung]

What about the fact that you haven't seen any phase 2 results despite a phase 3 greenlit being almost over? Usually, when a company has top tier drug results they are screaming it at every publication who will listen, and that doubly goes for a company like Kintor who's stock dropped 80% due to a mishandled phase 3 trial around the same time that they had the phase 2 results ready to apply for phase 3.

Again, happy to be proven wrong, all I'm saying is to take whatever those results are with some skepticism. It will probably be a great addition for people with moderate hairloss, but it's probably not going to replace finasteride/dutasteride in guys with more advanced loss.

Tbh, their Covid drug that seemed to fail has now favourable results as well. They didn't'scream' about those as well. We'll see. RU gives plenty of people years of stabilization. Nobody knows, Lets wait out the GB and june.

 

[badnewsbearer]

One difference though is that Pyrilutamide has a way higher binding affinity than breezula (breezula is super weak, like 30 times weaker than testosterone). So hopefully pyrilutamide can hold its results for longer.

but the dosage is also much weaker. that is another factor

 

[Baldingtooyoung]

How long are the GB guys now trying this? If Phase II results is good and the GB also report positive effects, I want to get this ASAP

 

[HMI 115 IS THE CURE dude]

Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial - PubMed

Orion Corporation Orion Pharma, Endo Pharmaceuticals Inc.

pubmed.ncbi.nlm.nih.gov

ODM-201 is a novel androgen receptor (AR) inhibitor designed to block the growth of prostate cancer cells through high-affinity binding to the AR and inhibition of AR nuclear translocation. This trial assessed ODM-201's safety, pharmacokinetics, and activity in men with metastatic castration-resistant prostate cancer.

this androgen receptor inhibitor can have really good uses for androgenic alopecia. It could have the same off label effect as finasteride. I wonder how the efficacies compare, in terms of hair growth. This is already completed phase 2 for prostate cancer

 

[Dimitri001]

One difference though is that Pyrilutamide has a way higher binding affinity than breezula (breezula is super weak, like 30 times weaker than testosterone). So hopefully pyrilutamide can hold its results for longer.

Not if the speculated AR upregulation is the reason for the dropoff in results. If anything it could lead to it falling off the cliff sooner.

 

[BetaBoy]

Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial - PubMed

Orion Corporation Orion Pharma, Endo Pharmaceuticals Inc.

pubmed.ncbi.nlm.nih.gov

ODM-201 is a novel androgen receptor (AR) inhibitor designed to block the growth of prostate cancer cells through high-affinity binding to the AR and inhibition of AR nuclear translocation. This trial assessed ODM-201's safety, pharmacokinetics, and activity in men with metastatic castration-resistant prostate cancer.

this androgen receptor inhibitor can have really good uses for androgenic alopecia. It could have the same off label effect as finasteride. I wonder how the efficacies compare, in terms of hair growth. This is already completed phase 2 for prostate cancer

lol it's well past phase II, ODM-201 or Nubeqa was approved way back in 2019

 

[JohnDoe5]

lol it's well past phase II, ODM-201 or Nubeqa was approved way back in 2019

I just checked and you ARE right. ODM-201 is being marketed under the name Nubequa. It is already on the market. It's been on the market since 2019. This guy, "HMI-115 is the cure" has had his head up his *** for so long he has forgotten what fresh air smells like. He's a toad.

 

[dahman]

How are the side effects looking from pyril?

 

[Dr sanches]

How are the side effects looking from pyril?

Heart palps and doesn’t even work