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

[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.

[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.

[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.

[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.

[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?

[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.

[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.

[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]

Why is everyone on this forum so stuck on exclusive usage of treatments. I mean if Replicel and Setipripant both come out, you could use both of them.

That is the point of all the new possible treatments coming out (CB, Sm, Septipripant, Replicel, Histogen and even Pilofocus).

Replicel has the best safety profile. However I am betting that Histogen has the best effectivity.

In the end the more of them come out, more options we hive. I'm sure there will be people using all of them at once.

I'll be signing up for any and ALL non-hormone altering options.... so, yeah; Minox + Histogen + Replicel + Setipripant + BIM + CB + RU. At that point, I'd expect serious results.

[Sogeking]

In any case, it will be interesting to see.

If replicel comes out with their product anytime near when these guys do, and replicel works, it's gonna be a much better option.

Why is everyone on this forum so stuck on exclusive usage of treatments. I mean if Replicel and Setipripant both come out, you could use both of them.

That is the point of all the new possible treatments coming out (CB, Sm, Septipripant, Replicel, Histogen and even Pilofocus).

Replicel has the best safety profile. However I am betting that Histogen has the best effectivity.

In the end the more of them come out, more options we hive. I'm sure there will be people using all of them at once.

[sdsurfin]

In any case, it will be interesting to see.

If replicel comes out with their product anytime near when these guys do, and replicel works, it's gonna be a much better option.

[It's2014ComeOnAlready]

This audio said nothing about delivery method. "the novel method of use".

That's correct, and I wasn't trying to further my point by making that post. Just trying to share information in a helpful way. Anyway, they bought all the patents, which say topical. Who knows how they are going to administer it. I only doubt that it's oral, because they already tested it orally in healthy men and women.

Yes, also other PGD2 inhibitors have the same effect, but they chose this drug because of "specificity and safety."

[sdsurfin]

Cool. Thanks for elucidating. I get bad sides from everything, and when I take zyrtec or claritin I get mild headaches and sometimes bad drowsiness. Might expect similar from this drug, a lot will probably tolerate it better, and some worse. I'm still most concerned about the withdrawal possibility after years of use, and would love to be able to talk to an expert about it. Sucks that kythera has no email.

[Justinian]

I only mention these side effects because the percentages were very high, the incidence of such effects is very high with other antihistamines, and there is a withdrawal effect from these drugs that is not talked about even by many doctors. There are always low percentages of people that report headaches and drowsiness, but not at these percentages. If that's too hard to understand I don't know how else to say it. Talk to anyone who has taken zyrtec. I too hope that the side effects will be outweighed by the positives. Just don't get your hopes too high.

Also, Kythera purchased cotsarellis' patents, but that doesn't mean they will follow those patents. From their shareholders presentation its pretty obvious they plan to develop and test this as a pill. Is it possible to make it a topical? who knows, probably. Either way the side effect shouldn't vary much.

The side effects you're referring to were from a sample size of 20, so 2 people getting a fairly common human feeling = 10%. There was no placebo to compare to. Here is the excerpt from the study at http://www.ncbi.nlm.nih.gov/pubmed/24095247

"Setipiprant was well tolerated at the tested dose, with no apparent effects on clinical laboratory variables, vital signs, weight, ECG variables, or ECG morphology. In total, 10 of 20 subjects reported at least one adverse event (AE) during the study. Headache was the most frequently reported AE (in 25% of subjects), followed by flatulence (15%) and somnolence and fatigue (10%). Only 1 case of headache, 1 case of somnolence, and 2 cases of fatigue were judged to be related to study drug by the investigator.

No AEs of severe intensity and no serious AEs were reported during the study. One case of moderate headache (1 man, treatment A) and 2 cases of moderate fatigue (2 women, treatment B) were reported; all other AEs were rated to be of mild intensity by the investigator. All AEs resolved without sequelae. The AE incidence in men and women and between treatments was similar."

[sdsurfin]

It's been posted, but I'll repost. Here's an audio recording from people at Kythera discussing this drug for hair loss:

https://clyp.it/41mcx0mb

This audio said nothing about delivery method. "the novel method of use" bought by kythera and provided by Upenn simply means the act of using setipriprant as a hair growth molecule. The molecule itself is being bought from actelion. Again, you are misunderstanding what people say and reading into things.

This is no big deal yet, they have no idea how it will work in vivo. Ramatroban keeps hair growing in vitro as well. Hopefully it wrks, but certainly no guarantees. Propecia maintains hair and grows a good amount in many people, so there's no way this gets released if it isn't as good, and other PGD2 receptor blockers have not panned out very well in unofficial trials.