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

[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.

[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

[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.

[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

[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.

[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]

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

[sosa56]

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

[It's2014ComeOnAlready]

The chief medical officer of Kythera that's quoted in the press release used to be the chief medical officer of Allergan and was the go-to guy to explain bimatiprost for hair during their conference calls. Might not mean much (or anything) but if we could download the contents of his brain on here we'd probably know some interesting things about the potential for both of these treatments.

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.

[beetee]

C

[beetee]

The chief medical officer of Kythera that's quoted in the press release used to be the chief medical officer of Allergan and was the go-to guy to explain bimatiprost for hair during their conference calls. Might not mean much (or anything) but if we could download the contents of his brain on here we'd probably know some interesting things about the potential for both of these treatments.

[It's2014ComeOnAlready]

Count me in. But what means by IND?

It allows the company to transport the investigational drug across state lines for means of research. Since this is already a heavily investigated drug with 8 clinical trials, 7 pubished papers etc they probably won't have any trouble getting it.

[It's2014ComeOnAlready]

I'm pretty sure they would need to do one trial only. They have trialled this drug 8 times, have gotten through the fda hurdles. I'm assuming they're going to prepare a new formulation that needs to be tested, and given the extensive and well known safety profile, only need to know if it works.

I'm sure they already know it works. Otherwise you wouldn't have this company buying the rights to produce it and run one trial. The company isn't even a huge pharmaceutical like merck or gsk or actavis.

[sosa56]

Is anyone able to listen to this http://leerink.metameetings.com/conf...hp?ticker=KYTH

Might contain useful info

[Jonathan]

Count me in. But what means by IND?

http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm