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

[Parsia]

As far as I know, the proof of concept trial will be phase 2 essentially. They could test different dosages here. They would then have to do a phase 3 to prove efficacy. It's dumb yes, but to my knowledge that's how it will work. Since they already did a phase 3 it would make sense for them to be able to market it after a phase 2, with a buyer knowing that it has only been safe not effective.

Also, this probably won't be a miracle cure in oral formulation since plenty of balding men had to have taken it in previous trials. It could definitely be a better finasteride that works more downstream, and in combination could contribute to a very effective regrowth solution.

Thanks for the info , So my question is why we don't hear anything about that until phase 3? I just got surprised because we always track new treatment and know about the company and also their trail phase and even wait for the next phase and most likely they fail or file the bank ruptcy, But for this one it came to news after phase 3 ! so whats going on actually?

[Justinian]

Yes, but do you see how it makes no sense to do 2 trials? One would be to determine the efficacy and safety in a smaller group, and the last would be to test the efficacy in a large group. If you've already tested the safety in over 1000 men and women and found no problems, you would just have to be testing the efficacy of your product. I'm fairly certain they already know this works, otherwise they wouldn't be trialling a hair loss medication based on a hypothesis, if the hypothesis wasn't already correct.

I'm not certain, and you're not certain. But I think my interpretation makes more sense, given how studied this drug is, on top of already testing the safety and tolerability on healthy men and women.

Unfortunately, just because your interpretation makes sense it doesn't mean that's how the FDA does it. If they have the dose figured out, I would think maybe they could go straight to phase 3, but they specified proof of concept trial which would not be phase 3.

[Trouse5858]

Realistically if things go well, how long to get this to market? 3 years?

[hellouser]

Realistically if things go well, how long to get this to market? 3 years?

They're sayng they can jump into Phase 2a right away... so:

1 year before they start trials (dont expect anything to start this year, theyre all slow)
1 year for phase 2a
1 year for phase 2b
1 year for phase 3
Time between phases for obligatory slacking
Time after phase 3 for FDA's ridiculous final green light.

SIGH.

[Parsia]

Realistically if things go well, how long to get this to market? 3 years?

I also have the same question ? anyone ? but please be realistic about your answer ! I don't want to put my expectation too high.

[It's2014ComeOnAlready]

Unfortunately, just because your interpretation makes sense it doesn't mean that's how the FDA does it. If they have the dose figured out, I would think maybe they could go straight to phase 3, but they specified proof of concept trial which would not be phase 3.

You are assuming you know what the FDA rule is. I am interpreting how they could do it, given that this drug has been trialled 8 times. Finasteride took a year to come out for hair loss after it had been approved for BPH. They had to lower the dose and run a trial. In this case, they know the optimal dose, they just need test that their formulation works for hair loss. Which, they already have in vitro, and in Follica's hair regeneration trials.

You guys just don't want to accept great news. That's it.

[RGPHILPA]

In the link to the audio interview posted the speaker specifically states that they can begin at a phase IIa. They'll definitely need to know the efficacy in a broader, more diverse patient population so will most likely require further trials than the POC. But....since they know it's safe, maybe they can run the efficacy concurrently while commercializing? I don't know. I think this one is close, within the 5 year window.

What i found interesting was that the speaker mentioned that they have good intellectual property protection, not only for the compound, but for "the method of use". He describes the method as a novel insight that came out of the labs of Upenn. I'm guessing this would be a reference to the wounding protocol that was patented with Cotsarelis's name on it. That would succinctly explain why Follica went silent two years ago and laid off all their staff when this agreement was made. Does anyone know otherwise?

I also liked to hear that these trials will be cheap for them. Cheap means fast. No begging for funds necessary.

This is definitely the best news that i've heard hear in a long time.

[Justinian]

You are assuming you know what the FDA rule is. I am interpreting how they could do it, given that this drug has been trialled 8 times. Finasteride took a year to come out for hair loss after it had been approved for BPH. They had to lower the dose and run a trial. In this case, they know the optimal dose, they just need test that their formulation works for hair loss. Which, they already have in vitro, and in Follica's hair regeneration trials.

You guys just don't want to accept great news. That's it.

I think this is really good news, I'm just trying to be realistic with how the FDA works.

[Jonathan]

Can someone explain what I am missing?
- We know that setipiprant is safe
- The recognized Dr George Cotsarelis says it work and is better than Finansteride
- A big biopharmaceutical company believes in it and have put a lot of money in it
- They will start to sell it as soon as the paperwork/proof is done
- We can buy it today, eg here: http://www.keyorganics.net/bionet/se...19fn2o3-1.html

Why are we not all ordering this already? What are we missing. The dosage? Do we need other ingredients than Setiprant?

[finco]

Yeah do we know what the optimal dosage actually is? If so could someone link me to this info.

Also the presentation said that there have been around 8 trials done on the drug, not of these study results are available as far as I know. And not mention of significant regrowth of hair has been noted in these trials, or not been reported.

[It's2014ComeOnAlready]

Yeah do we know what the optimal dosage actually is? If so could someone link me to this info.

Also the presentation said that there have been around 8 trials done on the drug, not of these study results are available as far as I know. And not mention of significant regrowth of hair has been noted in these trials, or not been reported.

Page 7 http://files.shareholder.com/downloa...0Deck%209FEB15

[finco]

Page 7 http://files.shareholder.com/downloa...0Deck%209FEB15

Thanks but that's in vitro.

[It's2014ComeOnAlready]

Thanks but that's in vitro.

Can you tell me why that makes a difference? You don't know how this will even be delivered as a drug. If they can determine the proper molar concentration per hair follicle, they can probably determine the dose.

[sdsurfin]

Can someone explain what I am missing?
- We know that setipiprant is safe
- The recognized Dr George Cotsarelis says it work and is better than Finansteride
- A big biopharmaceutical company believes in it and have put a lot of money in it
- They will start to sell it as soon as the paperwork/proof is done
- We can buy it today, eg here: http://www.keyorganics.net/bionet/se...19fn2o3-1.html

Why are we not all ordering this already? What are we missing. The dosage? Do we need other ingredients than Setiprant?

Well for starters it's 65 Bucks for 1 mg. Zyrtec has 10mg of pgd2 blocker per tablet. Maybe look into china to get it cheaper. I think the evidence that pgd2 pathways can stop hair loss is pretty damn conclusive. I'll be getting on centrifuge or ramatroban asap until this comes out in three years or so. My guess is they do a phase 2 and then a phase 3 and if it works it'll prob get released at the same time as bim. I'm hopeful about results the question is will the side effects be worth it. Bim has shown gnarly eye swelling even when not put in the eye, and these allergy mess cause serious withdrawal after a while and also make people drowsy and give headaches, and far more peeps get sides than with propecia. We should all be bugging kythera to consider this as a topical. If anyone has contact info for them pass it along. Or if you're in Cali plan a visit with their head of research, he's a dermatologist. Would be great to put a bug in his ear about reducing sides via topical application. And also ask him about bim eye swelling.

[Illusion]

Regarding the link > page 7: P=0.001 means it's a concentration of 0.001%? (I'm sorry I'm absolutely not familiar with this lol)