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

[woodnor]

Hey guys, maybe someone can help me understand this :

Why is it that nobody had trialed setipiprant for hairloss before if Cotsarelis made the discovery of PGD2 and hairloss in 2011? Is it because they needed funding?

Also, was Cotsarelis involved in Kythera getting the funding for the trials?

[hellouser]

Hey guys, maybe someone can help me understand this :

Why is it that nobody had trialed setipiprant for hairloss before if Cotsarelis made the discovery of PGD2 and hairloss in 2011? Is it because they needed funding?

Also, was Cotsarelis involved in Kythera getting the funding for the trials?

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.

[RGPHILPA]

Here's the patent kythera purchased the rights to. It states the the application will be topical, although no mention has been made about the delivery, besides this.

https://www.google.com/patents/WO2013142295A1?cl=en

Thanks for posting. I didn't see that this was the patent they acquired. The "novel" approach mentioned appears to be in regards to going after PGD2/GPR44 for treating hairloss rather than the actual delivery of the drug. So, most likely you're correct. But....and this a big kim kardashian sized butt..... i would like to direct your attention to one particular part of the patent which i think is interesting and could be referring to the wounding protocol from Follica:

[0081] Other therapeutically effective agents / treatments for a combination therapy to enhance hair growth include, for example, but not limited to, transplantation surgery and removing dermis or epidermis. Other therapeutically effective agents / treatments include for a combination therapy to inhibit hair growth include, for example, but not limited to, removing hair on skin by mechanical or chemical methods known to one of skilled in the art.

So, this patent is basically wide open and covers a lot ground. So, it's tough to figure out where they're going with it. But, what they've written in section 81 is pretty much a play by play from Follica's initial business plan. They had mentioned using their technique for both hair growth and removal. And here we come across it again. The mention of combination type therapy makes me think that they definitely could be involved here. However, you may very well be right and this will be a more straight up topical, medication only type of approach.

None the less, very, very exciting news.

[It's2014ComeOnAlready]

Can anyone with knowledge of how clinical trials work tell us how many trials they will have to do for this? They have done a lot of work in regards to safety and dosing, would that mean all they have left is efficacy?

Their CEO also mentioned a proof-of-concept would cost them $10 million. That sounds like a lot for one trial, maybe it's a trial to determine efficacy in a large population?

[hellouser]

Can anyone with knowledge of how clinical trials work tell us how many trials they will have to do for this? They have done a lot of work in regards to safety and dosing, would that mean all they have left is efficacy?

Their CEO also mentioned a proof-of-concept would cost them $10 million. That sounds like a lot for one trial, maybe it's a trial to determine efficacy in a large population?

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.

[sdsurfin]

They are starting with IIb, I'm not positive whether this counts as their proof of concept or if there is a POC and then a 2b.
they would still have to do a phase 3, and then get it approved. Basically they have to show efficacy and proof that it makes sense, and then phase 3 is to really nail it down in a large group of patients. Hopefully it goes better than their asthma trials.

[HairlossAt15]

They said phase 2b in the Web cast. But they already have a team and lab setup so it shouldn't take as long, also on their website it says they have 100 million(entire company) available and this trial will only take around 10 million.

So it shouldn't take to long, once phase 2b is finished they will have data on how much hair growth patients got from the treatment(since phase 2b is on human patients)

In other words it won't be long until we have some real idea about how good this will be.

[Sogeking]

They are starting with IIb, I'm not positive whether this counts as their proof of concept or if there is a POC and then a 2b.
they would still have to do a phase 3, and then get it approved. Basically they have to show efficacy and proof that it makes sense, and then phase 3 is to really nail it down in a large group of patients. Hopefully it goes better than their asthma trials.

How can you be sure that it is Phase2b? Although if it is, then it could be out on the market in 5 years.

Granted the sum of 10mil mentioned before does usually pertain to Phase 2 and higher...

@HairlossAt15
Well in that case that is really fast possible approval process.

[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.

[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)

[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.

[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]

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.

[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.

[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.