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

[It's2014ComeOnAlready]

I'm putting my estimation at 2 years. POC to establish efficacy, then a phase 3 with a larger group. An NDA can be filed during the duration of phase 3, shortening the entire process.

When they tested this drug for asthma, they did a POC and then a phase 3.

to quote Cotsarelis: "Companies in general try to keep the number of trials to the minimum. The more trials you do, the greater the chances for an adverse effect to be found."

[sdsurfin]

I'm not sure clinical trials move any faster now than they used to. Pretty sure they don't. The science does for sure.

[sdsurfin]

I was under the impression cet lowered pgd2 levels as a whole opposed to blocking receptor sites

It blocks the h1 receptor. Not sure if they know how it lowers pgd2.

[ledhead]

I was under the impression cet lowered pgd2 levels as a whole opposed to blocking receptor sites

Also I've been looking into antihistamine side effects more, and I think my prior fears were probably a bit overblown. Cetirizine blocks a very different receptor than setipiprant, and even in the case of cetirizine withdrawal, it was usually after many years, and people were able to get through it by reducing dosage over a few weeks. Definitely nothing as scary as propecia. I'm sure Pip will have side effects, but probably none that are horrible, and most people should probably be fine on it. What worries me most is the drowsiness, but we can only speculate as to how bad that will be. hopefully not bad.

[oppenheimer82]

you should contact them. normal clinical trials usually take between 7-15 years. So 5 years isn't bad really in the grand scheme of things. The POC will prob be the only trial before phase 3, but it might take a year just to file for and plan that trial, if not longer. these things take time.

In more positive news, these guys http://www.pulmagen.com/adc3680.html

and also the guys developing OC045 are both developing antagonists of the same receptor, and are already done with phase 2b trials. We could see one of those come out soon, and they are probably very very similar. Kythera could not have purchased the rights to those because they are already licensed and in development for other things, but i doubt they are too different.

I know its easy to get down about this, but basically we are in the transition phase between the propecia generation, which was ****ed, and a new generation of treatments. We're lucky to be on the brink of these things, and not in the days of our grandfathers, when there was nothing. I am a huge skeptic and not generally optimistic about progress in medicine, but I truly do think we will have several better options in 5 years, 8 or ten at the most. If replicel pans out then we can pretty much kiss this thing goodbye, which is really saying a lot.

In the meantime don't spend your time on this stuff, I'm trying to figure out if there's a viable maintenance option right now, just got some RU and might try topical fin, and if nothing works then I'll just ride it out. Shiseido makes a topical called Adenogen, which I can't attest to the efficacy of yet, but it has not given me any sides, and i get sides from even minox. I know a lot of people who kept their hair for 3 or 4 years just on minoxidil, so just do what you can, don't stress, and I think better days are coming. If you're already noticeably bald then I suggest you just buzz it down and love yourself, don't be like the psychos on here that proclaim it's a death sentence or that people hate bald guys. Ive been around and that has not been my experience in the least. The women on my moms side of the family were all gorgeous, and all married bald men, and the women on my dads side were not gorgeous and married full haired men. Good indication of how much it matters to others. If you love yourself others will love you. It's a strugge for everyone, and no one is 100 percent satisfied with life. If they are they are just waiting for a struggle to happen. My best looking most full haired friend just lost his mom to alzheimers at a pretty early age, so imagine what he has to worry about. Life's a bitch for everyone, so just be positive and know that hair means almost nothing. I'm out for now.

we all know your opinion now. could you stop trolling please?

[NeedHairASAP]

As a reference, it took merck 5 years to approve propecia for MPB once it was already approved for the prostate. Setipiprant has not been approved for anything yet. So you can estimate how long this might take from those numbers unless there's some other caveats that i'm not aware of. OC045 is in phase three trials I think, so we might be able to use that sooner off label.

As a reference to your reference, email didn't even exist then. Things move faster and faster everyday.

[sdsurfin]

As a reference, it took merck 5 years to approve propecia for MPB once it was already approved for the prostate. Setipiprant has not been approved for anything yet. So you can estimate how long this might take from those numbers unless there's some other caveats that i'm not aware of. OC045 is in phase three trials I think, so we might be able to use that sooner off label.

[sdsurfin]

Also I've been looking into antihistamine side effects more, and I think my prior fears were probably a bit overblown. Cetirizine blocks a very different receptor than setipiprant, and even in the case of cetirizine withdrawal, it was usually after many years, and people were able to get through it by reducing dosage over a few weeks. Definitely nothing as scary as propecia. I'm sure Pip will have side effects, but probably none that are horrible, and most people should probably be fine on it. What worries me most is the drowsiness, but we can only speculate as to how bad that will be. hopefully not bad.

[sdsurfin]

you should contact them. normal clinical trials usually take between 7-15 years. So 5 years isn't bad really in the grand scheme of things. The POC will prob be the only trial before phase 3, but it might take a year just to file for and plan that trial, if not longer. these things take time.

In more positive news, these guys http://www.pulmagen.com/adc3680.html

and also the guys developing OC045 are both developing antagonists of the same receptor, and are already done with phase 2b trials. We could see one of those come out soon, and they are probably very very similar. Kythera could not have purchased the rights to those because they are already licensed and in development for other things, but i doubt they are too different.

I know its easy to get down about this, but basically we are in the transition phase between the propecia generation, which was ****ed, and a new generation of treatments. We're lucky to be on the brink of these things, and not in the days of our grandfathers, when there was nothing. I am a huge skeptic and not generally optimistic about progress in medicine, but I truly do think we will have several better options in 5 years, 8 or ten at the most. If replicel pans out then we can pretty much kiss this thing goodbye, which is really saying a lot.

In the meantime don't spend your time on this stuff, I'm trying to figure out if there's a viable maintenance option right now, just got some RU and might try topical fin, and if nothing works then I'll just ride it out. Shiseido makes a topical called Adenogen, which I can't attest to the efficacy of yet, but it has not given me any sides, and i get sides from even minox. I know a lot of people who kept their hair for 3 or 4 years just on minoxidil, so just do what you can, don't stress, and I think better days are coming. If you're already noticeably bald then I suggest you just buzz it down and love yourself, don't be like the psychos on here that proclaim it's a death sentence or that people hate bald guys. Ive been around and that has not been my experience in the least. The women on my moms side of the family were all gorgeous, and all married bald men, and the women on my dads side were not gorgeous and married full haired men. Good indication of how much it matters to others. If you love yourself others will love you. It's a strugge for everyone, and no one is 100 percent satisfied with life. If they are they are just waiting for a struggle to happen. My best looking most full haired friend just lost his mom to alzheimers at a pretty early age, so imagine what he has to worry about. Life's a bitch for everyone, so just be positive and know that hair means almost nothing. I'm out for now.

[HairlossAt15]

Just re-listened to webcast, he said phase 2a POC trial, but I cant imagine it will take that long and it will still be done on human patients, meaning we will have data within a few months hopefully.

[It's2014ComeOnAlready]

Gah I hope it's not 5 years. I don't see why they couldn't establish efficacy in a POC, then jump to phase 3, meanwhile filing NDA approval during phase 3 to speed up the process. It's a drug that has been studied in 8 trials, what else would you need to know other than that it works?

I think you guys are going by what the standard is for clinical trials (and I get that). I think this case may be different due to how studied it is, that it has had a phase 3 etc.

I might try and contact them to see if they could answer this.

[sdsurfin]

I see. However, their CEO mentions they're done with dosing as well. The only thing they would really need to prove is efficacy with a large enough group. They only mention the POC in their future development plans with this drug. I seriously wonder if all they need is one trial then approval.

They are at phase 2b. that means they need to do two trials. first they have to file for an IND and proof of concept. So really it would be about 4 years minimum. 1 yr POC, 1 yr 2b, 1 yr phase 3(if they do one, maybe they don't need it?) and one year min to file for approval.

It really blows that we have to wait around 4 or 5 years for anything of substance, I think this time the 5 year wait is actually realistic, but gotta find a way to maintain until then. If we're incredibly lucky we might have replicel in japan or SM or Bim here in three years.

Is anyone on RU and maintaining? I can't take fin or minox, and I'm trying cetrizine but i feel tired and throaty all the time on it. I do think replicel will be solid, but I gotta hold on until then.

[It's2014ComeOnAlready]

Phase 2A, 2B and 3.

Then it requires a FINAL approval from the FDA before going commercial. In reality, they've only skipped Phase 1 because its already been tested for safety.

I see. However, their CEO mentions they're done with dosing as well. The only thing they would really need to prove is efficacy with a large enough group. They only mention the POC in their future development plans with this drug. I seriously wonder if all they need is one trial then approval.

[woodnor]

Because there's no way of getting it and the only PGD2 inhibitors that were ever tried were CETIRIZINE and 'OC' neither of which were proper.

What did you mean by "there's no way of getting it"? Did you mean that there was no way of getting setipiprant before? (If you meant that), wasn't setipripant being trialed already for something else before? (sorry I don't really understand how all the protocols work)

[Bald Russian]

Can i add my 2 cents? Another 5 year...
Already any new story is so ironic bad joke. Already dont belive that anything will be good. I tired to use some chemicals on my head, skin hurts... I gonna shave head and forget about hair, sad but true.