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

[sosa56]

So did and anyone listen to the company conference call I linked?

[It's2014ComeOnAlready]

So did and anyone listen to the company conference call I linked?

You can't listen unless you login with a company. I think it will be posted afterward, after it's edited. Then we can listen

[Justinian]

You guys have literally been missing all the signs. Both work on prostaglandins, one stops hair loss, the other will regrow. It is the holy grail of treatments. Bimatoprost finished up its phase 2b study back in Nov when Allergan was sold for $13 billion more than any company was willing to offer. They planned on releasing their info for their phase 2b study in January, are now saying you'll have to wait for those results until 2016. Also, setipiprant has an excellent safety profile with over 1,000 men and women being tested. Not to mention that it has passed 8 trials. It would only need to do a proof-of-concept to test the efficacy of the application. Even the optimal dose has already been determined.

All those years of research by Cotsarelis and Follica, are now being funneled into one proof-of-concept trial. Then we have new treatments. Holy crap.

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.

[It's2014ComeOnAlready]

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.

If you look at their presentation, it shows that they've already determined the optimal dose. Also, they've proved it's effective and it works in vitro. Cots is the foremost expert on hair research and he just partnered with a company to produce a treatment with a drug that's FDA approved.

[hellouser]

You can't listen unless you login with a company. I think it will be posted afterward, after it's edited. Then we can listen

Audio recording can be found here:

https://clyp.it/41mcx0mb

[Justinian]

Oh I must have missed the part about the dose.

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

[sosa56]

If you look at their presentation, it shows that they've already determined the optimal dose. Also, they've proved it's effective and it works in vitro. Cots is the foremost expert on hair research and he just partnered with a company to produce a treatment with a drug that's FDA approved.

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

[hellouser]

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

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

[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.

[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.

[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.

[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.

[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.

[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]

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.