Kythera Acquires Rights to PGD2 Blocking Setipriprant for New Hair Loss Treatment

[sdsurfin]

2014, we're all as hopeful and as excited as you on the development of this drug. However, you need to accept that sdsurfin has made some valid and very real points. While we may not want to hear them, they are possibilities that must be considered, weighed, and remind ourselves of. Not everything is perfect. His points on the effects of prolonged antihistamine usage is valid. Be respectful, please. We're all brothers in the hairloss boat.





Remember, we're all brothers in this. No need to be name calling and such. We're all old enough to avoid that. I think your points are valid and useful and I'm happy that you've presented them. Whether it's good or bad news all news is important to gauge the possible efficacy of these future treatments and if we have reason to be wary or concerned.

true and my bad, I didn't start the name calling but I should just ignore it.

[sdsurfin]

Lmao cotsaerlis spells out in his studies how big of a impact pgd2 has on hair growth. Then the Kythera presentation translates it into laymen terms. Human hairs grows as normal when pgd2 effect is removed, simple as that.

Headaches are normal side effects in any trial... Probably just placebo effect from paranoid testers...

? I don't even know if you read any of what I wrote. Everything you say is true but it has nothing to do with what I'm warning people about. Just because a drug works doesn't mean it's gonna be pleasant or worth it to take. And we don't even know if it works. Kythera are taking an informed gamble on something tested in vitro and with a good theory behind it. That doesn't mean this drug is the perfect way to implement that knowledge. Blocking the DHT pathway is even better but we still haven't gotten the perfect drug to deal with that. Just saying we are in very preliminary areas, and tbh hair growth was not an astounding aspect of any of their past trials, so IMO it's def not a miracle cure. Millions of people take zyrtec or claritin, but they are warned not to take it for too long. This was not a warning or an issue in the trials for these drugs, and many doctors don't even know that you can withdraw from them, but it's possible and maybe probable after long enough use. Even if you don't withdraw, being exhausted and headachy and farting all the time is pretty awful. And no headaches weren't a placebo effect, at 25%. thats too many people to just make something up. Not to mention its a well documented major side effect of other antihistamines. If you can't understand what I'm saying then just forget about it. I would like the people that do understand to ask knowledgeable people and scientists what they think. that's all.

[Gerhard]

true and my bad, I didn't start the name calling but I should just ignore it.

It's all good, brother. We can all get frustrated sometimes. Trust me, I am definitely not a paragon of calmness or anything! But I can understand why tension can run high in this. We all put our faith and trust into something and we hope that it works out, but the reality is that even if it is a milestone there are a lot more factors before it can be a success. Some people see that and some people don't want to. We all just have to remember that the best thing we can do is work together and update with beneficial questions, concerns and progress.

? I don't even know if you read any of what I wrote. Everything you say is true but it has nothing to do with what I'm warning people about. Just because a drug works doesn't mean it's gonna be pleasant or worth it to take. And we don't even know if it works. Kythera are taking an informed gamble on something tested in vitro and with a good theory behind it. That doesn't mean this drug is the perfect way to implement that knowledge. Blocking the DHT pathway is even better but we still haven't gotten the perfect drug to deal with that. Just saying we are in very preliminary areas, and tbh hair growth was not an astounding aspect of any of their past trials, so IMO it's def not a miracle cure. Millions of people take zyrtec or claritin, but they are warned not to take it for too long. This was not a warning or an issue in the trials for these drugs, and many doctors don't even know that you can withdraw from them, but it's possible and maybe probable after long enough use. Even if you don't withdraw, being exhausted and headachy and farting all the time is pretty awful. And no headaches weren't a placebo effect, at 25%. thats too many people to just make something up. Not to mention its a well documented major side effect of other antihistamines. If you can't understand what I'm saying then just forget about it. I would like the people that do understand to ask knowledgeable people and scientists what they think. that's all.

For now we'll just have to wait and see what results they publish in the future and hope for the best. A lot of people will prefer to only look at the presentation pdf rather than also take the critiques you've posted as well. Again, thanks for posting them though. You've made me more aware of the situation and helped me determine what questions we should be asking of Kythera and trying to learn more about.

[sdsurfin]

Yeah I really wish someone would take the initiative to schedule an appointment with the guy in san diego, it would be very easy to do and might elucidate a lot. I know there are guys in cali on this forum. Regrettably cotsarellis is very hard to contact if not impossible, as is garza.

We could very well be one of the luckiest generations as far as hair loss is concerned, but it will def come at a price. We will probably see a better maintenance option than propecia in our time, and the next generation will likely get a pretty full cure. Between Prip and Bim and SM and replicel and CB something is gonna pan out, likely we will see a precentor drug and a growth drug, and probably a lot of guys will be able to handle the sides. This won't be a done, side free deal until they figure out gene editing, which will take a long long time. Even making new follicles, which is likely to happen in the next 20 yrs, will not be successful without medications that keep it going, and that means sides.

I think the best we can do is join forces and push for drug companies to be honest and to make either topical versions or oral formulations that truly take our health into consideration. I'm pretty pissed that we don't have a topical AA at this point, because there are several candidates better than CB, and I hope this pGD2 stuff won't stop them from being developed. they have less chance of causing sides than medications that **** with our immune receptors.

[HairlossAt15]

We are not on the same page, I have read all the papers from Cotsarelis and Garza and have a firm understanding of the Science and trial process.

First lets clarify how powerful placebo is:

"In the 1950's a man dying of advanced cancer learned of an experimental drug called krebiozen, which many people considered a miracle cure for cancer. The man desperately insisted he be given it. After a single dose his huge cancers "melted like snowballs on a hot stove" and he was able to resume normal activities.

Then disaster struck. Studies of krebiozen showed it to be ineffective, and when the man read this his cancer once again began spreading. At this stage his doctor tried an experiment. He announced that there was a new, "improved" krebiozen and the patient would now receive it. Once again the man's tumors shrank. Yet in fact the doctor had given him only water. [Case was reported in a medical journal in 1957]"

Now lets look at the side effects

Major : none!

Minor:

Headache (25%) : You cant record a headache with any apparatus, in trials the patients are simply asked "Did you feel any adverse effect e.g headache etc" (or something similar to that).To which people give their answer, for absolute transparency, these are noted down as official side effects.. even though you have no idea if it was the drug. It could be from any of these things : anger, frustration, dehydration, exhaustion (end of a hard week) etc etc. You can also easily talk yourself into a headache from paranoia. Just like you can talk yourself into stress, sadness etc.

Flatulence (15%) : Interesting one, but again hard to measure and confirm it is related to the drug, could just be from eating bad food etc. The patients are knowingly taking an "experimental" drug, leads to fear in some people - when I was young and naive I used to get sick to my stomach just when taking pain killers(before I even took them and then got worse after), just didnt like pills at all, would be afraid after taking it, leading to feeling sick to my stomach and puking a few times.

Somnolence and fatigue (10%) : Fatigue? You mean the feeling you have after a hard day at work? Come on guys, impossible to relate this to the drug. "10%" thats about the percentage of people who are depressed/stressed out all the time. Not even significant in any way.

I never said this was the cure, but it could very well be after some tinkering and adding some growth factors to.

"To test the effect of PGD2 on human hair growth, we used explanted human hair follicles maintained in culture for 7 days. We added increasing amounts (from 0 to 10 μM) of PGD2, 15-dPGJ2, or vehicle to the culture medium and measured hair length (Fig. 6D). Starting at 5 μM, PGD2 and 15-dPGJ2 significantly inhibited hair growth. At 10 μM, PGD2-treated hair was 62 ± 5% shorter than vehicle, whereas 10 μM 15-dPGJ2 completely inhibited all hair growth. We tested a variety of other PGD2 analogs and found them to be capable of inhibiting hair lengthening."

Blocking the DHT pathway is even better

How so? I think that will lead to far worse side effects..

This was not a warning or an issue in the trials for these drugs, and many doctors don't even know that you can withdraw from them, but it's possible and maybe probable after long enough use.

Good to see you are smarter than doctors. "Withdrawals", people say they get that from eating less chocolate..also its not a complicated concept, dont know why your making it out to be so..

If you can't understand what I'm saying then just forget about it. I would like the people that do understand to ask knowledgeable people and scientists what they think. that's all.

How pretentious...

[Thinning87]

I gotta say, sdsrufin brings up good points from time to time but he often goes way too far in his judgements. It's like he always knows everything that is going on behind the scenes in any company or lab. Any time there is an announcement by someone in the hairloss community you be he'll be here making his predictions. He called me a troll when I announced my roommate and my good friend's names were on the Sanford Burnham paper a few weeks ago. I reported what they told me personally and he insisted that I was full of it. Then he totally changes his mind days later when he reads the paper in more depth.

For once, sdsrufin you can just stop talking about everything because you're just another amateur poster on some forum. Please try to find something other than spamming the entire forum with your judgements about things you obviously don't know anything about.

[unbalding]

The concern for me is does your body compensate by increasing PGD2 further or producing more PGD2 receptors, thus making a permanent treatment more difficult when that comes along.

[It's2014ComeOnAlready]

Finasteride along with Setipiprant and Minox should yield some impressive results. I wonder what we can get in combination with Histogen/Replicel should either of them come to fruition.

I honestly believe there is a race to get setipiprant, as well as bimatoprost out there. You won't need anything else, treatment wise. One will stop hair loss, and the other will regrow spots you need it in. That's it. That's one of the reasons I find this very exciting.

[It's2014ComeOnAlready]

I would also like to make clear why I am so gung ho about this development. Cotsarelis has been working on the PGD2 thing since 2007, and he has selected a particular drug (one that has been exhausted in clinical trials) and a company to trial and produce it.

It says that 5 drugs worked in this pathway, but they chose this one because of it's efficacy with hair, but also because of how studied it is. This is not some company taking a chance at a potential new hair loss drug. All the hard work has been done, and they want to commercialize this as soon as possible. All the steps and measures have already been taken to ensure that this will work and they'll be successful. The trial is the least daunting part about it.

Other doctors, news outlets, Cotsarelis himself have always been very confident about this. We should be too if a pharmaceutical company wants to produce it. Companies don't put on more clinical trials with a drug that hasn't worked for something else, unless it surely works for something they can commercialize it for.

[unbalding]

I honestly believe there is a race to get setipiprant, as well as bimatoprost out there. You won't need anything else, treatment wise. One will stop hair loss, and the other will regrow spots you need it in. That's it. That's one of the reasons I find this very exciting.

Theoretically, but people have tried similar treatments that are already available with little to no success. I don't see how setipiprant should be any better than ramatroban. There are a substantial number of people out there who have used that along with various pgf2 analogues, and no miracle results have been reported. I myself just started using ramatroban today along with bimataprost .03%, and will start using D-cloprostenol next week. I'd love to try a higher concentration of bimataprost or latanaprost if I could find a reasonable price on quality powder.

[It's2014ComeOnAlready]

Theoretically, but people have tried similar treatments that are already available with little to no success. I don't see how setipiprant should be any better than ramatroban. There are a substantial number of people out there who have used that along with various pgf2 analogues, and no miracle results have been reported. I myself just started using ramatroban today along with bimataprost .03%, and will start using D-cloprostenol next week. I'd love to try a higher concentration of bimataprost or latanaprost if I could find a reasonable price on quality powder.

So, you're doubting that this will work at all because rubbing ramatroban on your head didn't work? Hm. They're spending millions of dollars to trial setipiprant for hair loss in a "novel approach." I sincerely doubt that this "novel approach" is rubbing a chemical all by itself on your head. I wouldn't call that a treatment, I'd call that rubbing a chemical on your head without any sort of vehicle.

Also, the issue with bimatoprost in trials had been concentration. In their phase 2b study, they upped the concentration 10X. 0.03% is very weak for hair loss, but it works for eyelashes.

[Energizer]

Wounding

Does anyone have any details on this wounding protocol? Is it a chemical peel? Mechanical? And how many cell layers does it penetrate? I was able to find this but not too much else: http://www.uphs.upenn.edu/news/News_...06/cotsarelis/

[It's2014ComeOnAlready]

The concern for me is does your body compensate by increasing PGD2 further or producing more PGD2 receptors, thus making a permanent treatment more difficult when that comes along.

Does taking propecia increase DHT or DHT receptors over time? No.

[RGPHILPA]

Theoretically, but people have tried similar treatments that are already available with little to no success. I don't see how setipiprant should be any better than ramatroban. There are a substantial number of people out there who have used that along with various pgf2 analogues, and no miracle results have been reported. I myself just started using ramatroban today along with bimataprost .03%, and will start using D-cloprostenol next week. I'd love to try a higher concentration of bimataprost or latanaprost if I could find a reasonable price on quality powder.

Laypeople have no clue what they're doing. They're just grabbing stuff off the shelf and slopping it on their heads and expecting regrowth. It's not that simple. Pharmaceutical companies spend significant resources and hire scientist who specialize in formulation development for a reason - it's difficult to get it right. The dose, the vehicle, frequency of administration etc... all need to be figured out precisely. They have significant effects on exposure, 1/2 life and toxicity. So, it's not surprising that no results were seen.

I wouldn't say this thing is a done deal. They'll still need to demonstrate efficacy that tops minoxidil and fin to really have a break through product. I think your average bald dude (i.e. those not on the forums) doesn't think minoxidil and fin will do a thing for them. My buddy is a classic example, hes a NW5 who tried minoxidil for a few months. He saw zero regrowth and gave up on it. I think a lot of people experience the same thing. For this treatment to become a big deal, they're gonna have to get impressive results. Something where, when you go on the drug, you get a very noticeable cosmetic result. That's really what will bring in the mainstream bald guy who's not familiar with anything that's discussed in these forums. I'm guessing that this efficacy will need to be 25% or more regrowth with a very high patient response rate. A homerun, where the treatment becomes a blockbuster, would probably have to approach 50% regrowth. To me, this is their biggest obstacle; getting a very high efficacy. It's not been achieved before.. It's fantastic that they already know it's a safe, well tolerated drug; which is the biggest killer of drugs in the clinic. So we have a good jump on it already.

I think this is our best shot - it's utilizing the most advanced understanding of MPB that the world has. Fingers crossed on the proof of concept!

[It's2014ComeOnAlready]

Does anyone have any details on this wounding protocol? Is it a chemical peel? Mechanical? And how many cell layers does it penetrate? I was able to find this but not too much else: http://www.uphs.upenn.edu/news/News_...06/cotsarelis/

This has nothing to do with wounding. Their trials for follicular neogenesis involved wounding, this is a new treatment to prevent hair loss.