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

[It's2014ComeOnAlready]

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)

It's the statistical significance. It would mean that their conclusion is with less than 1% chance that it is wrong.

[bigentries]

People need to be realistic with timeline projections.

Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010

This is a new drug, and from clinical studies, its efficacy has never been proved in vivo. Remember that, even Aderans and Intercytex had good results in proof of concept and in vitro studies. They need to demonstrate it does something first.

The only thing that keeps me optimistic is Cotsareli's involvement

[finco]

People need to be realistic with timeline projections.

Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010

This is a new drug, and from clinical studies, its efficacy has never been proved in vivo. Remember that, even Aderans and Intercytex had good results in proof of concept and in vitro studies. They need to demonstrate it does something first.

The only thing that keeps me optimistic is Cotsareli's involvement

You make a very good point. Wait on the POC trials in 2015/2016 and take it from there.

[walrus]

Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010

Dutasteride comes with similar disadvantages as finasteride. There is little to distinguish it to warrant pushing for a rapid release.

The PGD2 pathway will potentially avoid sexual side effects and the mechanisms have been demonstrated on ex-planted human follicles.

[It's2014ComeOnAlready]

People need to be realistic with timeline projections.

Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010

This is a new drug, and from clinical studies, its efficacy has never been proved in vivo. Remember that, even Aderans and Intercytex had good results in proof of concept and in vitro studies. They need to demonstrate it does something first.

The only thing that keeps me optimistic is Cotsareli's involvement

This is NOT a new drug. It's been tested in 8 clinical trials, including a phase 3. If you want to mention Cotsarelis, this is HIS work. He sold global rights to a company so that they can run a trial, market, and distribute it.

[beetee]

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.

I'm not missing the point. Why do you think I posted the information? However, we still don't know what if anything either will do, which is why no one else is acting like it's a done deal. But I think most agree this is a good thing and we are happier for the time being.

[bigentries]

This is NOT a new drug. It's been tested in 8 clinical trials, including a phase 3. If you want to mention Cotsarelis, this is HIS work. He sold global rights to a company so that they can run a trial, market, and distribute it.

It is a new drug, it has never been commercialised

Dutasteride has been commercialised, has been involved in several clinical trials, and it's widely prescribed off-label as a hair loss treatment because the medical community considers it safe and effective.

And still, it's not officially approved for hair loss, and it's been years since the approval process started. Why is this drug any different?

Cotsareli's involvement is not a guarantee of success. He also had some success with wounding and lithium almost a decade ago and that lead nowhere, any attempt from forum members to replicate those results failed

[hellouser]

Cotsareli's involvement is not a guarantee of success. He also had some success with wounding and lithium almost a decade ago and that lead nowhere, any attempt from forum members to replicate those results failed

This is a lie.

His successes with wounding and lithium did not 'lead nowhere' as the clinical trials with Follica are still ongoing.

[It's2014ComeOnAlready]

It is a new drug, it has never been commercialised

Dutasteride has been commercialised, has been involved in several clinical trials, and it's widely prescribed off-label as a hair loss treatment because the medical community considers it safe and effective.

And still, it's not officially approved for hair loss, and it's been years since the approval process started. Why is this drug any different?

Cotsareli's involvement is not a guarantee of success. He also had some success with wounding and lithium almost a decade ago and that lead nowhere, any attempt from forum members to replicate those results failed

It's not new in terms of development with the FDA. That's what's counts. Drugs that have been commercialized have made it through fda trials, which is why they've been released. This drug hasn't been released as anything else because what it was originally intended for (asthma) didn't have much of an effect. Nevertheless, it has been through 8 clinical trials, including a phase 3. This drug would be different because there would be no sexual side effects, plus women would be able to use it.

Cotsarelis is one of the most (if not the most) knowledgable doctors in hair research. This is his work, and he sold the rights to have it developed. If you read the presentation, it says that everything is in place for it to be a successful and efficient program towards commercialization. Lol why am I going back and forth with you, you don't even know his name, you keep calling him "Cotsareli"

[bigentries]

It's not new in terms of development with the FDA. That's what's counts. Drugs that have been commercialized have made it through fda trials, which is why they've been released. This drug hasn't been released as anything else because what it was originally intended for (asthma) didn't have much of an effect. Nevertheless, it has been through 8 clinical trials, including a phase 3. This drug would be different because there would be no sexual side effects, plus women would be able to use it.

Cotsarelis is one of the most (if not the most) knowledgable doctors in hair research. This is his work, and he sold the rights to have it developed. If you read the presentation, it says that everything is in place for it to be a successful and efficient program towards commercialization.

But again, those trials failed. We don't have any information about hair regrowth from those trials.

Dutasteride is considered efficient by anyone in the scientific community, and still hasn't received approval as a hair loss treatment. Why would a drug with failed trials and no assurance of efficacy as a hair loss treatment would have better luck than dutasteride?

And beware about any company promises. If you haven't, please read the archives from the Intercytex and Aderan efforts. People here and elsewhere even went to the point of cancelling HTs and making projected milestones timelines because they were told "that everything is in place for it to be a successful and efficient program towards commercialization.". Seriously, even Aderans had plans to roll out the treatment in Bosley clinics

Also, remember Follica. It's Cotsaserlis company too and it's been a decade of disappointments.

I think it's too early for this level of excitement

[It's2014ComeOnAlready]

But again, those trials failed. We don't have any information about hair regrowth from those trials.

Dutasteride is considered efficient by anyone in the scientific community, and still hasn't received approval as a hair loss treatment. Why would a drug with failed trials and no assurance of efficacy as a hair loss treatment would have better luck than dutasteride?

And beware about any company promises. If you haven't, please read the archives from the Intercytex and Aderan efforts. People here and elsewhere even went to the point of cancelling HTs and making projected milestones timelines because they were told "that everything is in place for it to be a successful and efficient program towards commercialization.". Seriously, even Aderans had plans to roll out the treatment in Bosley clinics

Also, remember Follica. It's Cotsaserlis company too and it's been a decade of disappointments.

I think it's too early for this level of excitement

I don't think you understand all of the information and circumstances. Those trials did not fail, the trials went fine, the drug wasn't commercialized because it didn't work for asthma.

Dutasteride has nothing to do with this.

These are not company promises, this is based on all the information in their presentation, if you actually took the time to read it.

Cotsarelis and Follica have been working for a decade on this and follicle neogenesis. He's sold to a pharmaceutical company so they can develop a new treatment based on all his work. A company is paying to do the trial based on the working hypothesis of the leading hair researcher in the world. They are taking on the cost, which means they believe in it. Companies do not trial drugs, especially drugs that have been through this many trials, unless it is highly likely to succeed and be commercialized.

It's not too early for this level of excitement if you understand what's going on, and how Cotsarelis' work has gotten to this point.

[HairlossAt15]

Half of you are incredible whiners.. The other half, are selfish and inpatient, wanting the product right now by any method and any means. No doubt if you got it and cured your hair loss, you would never come on these forums and help other people out... Time to grow up, this is the most promising news in the last decade at least, in 2012 cotsarelis said trials would start within 2 years, they started In 2013..just one year(they said they have been testing for 2 years already) ! Turns out he is honest after all..

[burtandernie]

If there ever was a time to be positive about some amazing news that came out of nowhere it would be now. You just need some patience. I would feel a little better once we see a little more about how well it works and what sides might emerge later on. This though might be the biggest news in a long time. It might get good regrowth and you throw BIM in the mix you might get a lot of hair back for the first time in history

[walrus]

An open access publication on how the drug is metabolised: http://link.springer.com/article/10....268-013-0031-7

[It's2014ComeOnAlready]

An open access publication on how the drug is metabolised: http://link.springer.com/article/10....268-013-0031-7

pee and poo. No sides.