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

[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.

[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.

[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.

[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.

[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.

[Trouse5858]

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

[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.

[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?

[It's2014ComeOnAlready]

If it cant regrow, i dont see it as much of an improvement over finasteride.

Cots was quoted as saying it would be more effective than finasteride. Plus, the plan is to release it alongside bimatoprost for regrowth.

[It's2014ComeOnAlready]

Proof of concept in drug development is usually Phase 1 or Phase IIa, so how do you guys know they are going to start with phase 2 or phase 3 trials? It was proven that CB-01-03 was safe, albeit in lesser percentage, with acne and yet they still had to do Phase 1, and Phase 2 trials.

They are re-purposing a drug, not developing a new one.

[It's2014ComeOnAlready]

I'm pretty sure the FDA does separate classifications for each use. The previous trials were not for alopecia, so they need a proof of concept for alopecia and then a phase 3 proving efficacy as far as I know. the previous trials only allow them to skip phase 1 and add additional safety data. It's dumb, but I'm pretty sure that's the way it is.

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.

[Sogeking]

Proof of concept in drug development is usually Phase 1 or Phase IIa, so how do you guys know they are going to start with phase 2 or phase 3 trials? It was proven that CB-01-03 was safe, albeit in lesser percentage, with acne and yet they still had to do Phase 1, and Phase 2 trials.

[Justinian]

This drug has been trialled many, many times. Including a safety and tolerability trial with healthy men and women, that concluded Sept. 2013. Who's to say that they can't do one very large proof-of-concept trial? All that is needed to be known now is if their method of delivering the drug works.

This is "first time hypothesis-driven approach taken to discovery of a hair growth treatment." That means after all those years of research, a company is taking the opportunity to test an already approved drug that follica had been using in their 2 follicle neogenesis trials. They know it works, and they want it to get it to market as soon as possible to be prescribed with bimatoprost.

I'm pretty sure the FDA does separate classifications for each use. The previous trials were not for alopecia, so they need a proof of concept for alopecia and then a phase 3 proving efficacy as far as I know. the previous trials only allow them to skip phase 1 and add additional safety data. It's dumb, but I'm pretty sure that's the way it is.

[It's2014ComeOnAlready]

Yes I think 2014 is on the right track, this is basically cots statement way back when about how pgd2 inhibitors already approved could help in aga coming to life, this biotech company have been working with cots labs for the past two years it seems, this is pretty significant news, I just hope that they can do the proof concept v quickly and get the phase 3 out of the way in a year. I also hope that the treatment can regrow rather than just being a preventative

Bimatoprost will be used to regrow. The chief medical officer at Kythera, also used to be the chief medical officer at Allergan. Go figure.

[It's2014ComeOnAlready]

Oh I must have missed the part about the dose.

I still think they will have to do a phase 3 for alopecia, though.

This drug has been trialled many, many times. Including a safety and tolerability trial with healthy men and women, that concluded Sept. 2013. Who's to say that they can't do one very large proof-of-concept trial? All that is needed to be known now is if their method of delivering the drug works.

This is "first time hypothesis-driven approach taken to discovery of a hair growth treatment." That means after all those years of research, a company is taking the opportunity to test an already approved drug that follica had been using in their 2 follicle neogenesis trials. They know it works, and they want it to get it to market as soon as possible to be prescribed with bimatoprost.