Kythera submits Setipripant for IND to FDA - 9/22

[username425]

From http://investors.kythera.com/releasedetail.cfm?ReleaseID=932602:

[h=1]KYTHERA(R) Biopharmaceuticals Submits Investigational New Drug Application for KYTH-105 to Treat Androgenetic Alopecia, or Male Pattern Hair Loss[/h][h=2]Novel Oral Treatment Could Bring New Option to Large, Unsatisfied Market[/h]

WESTLAKE VILLAGE, Calif., Sept. 22, 2015 (GLOBE NEWSWIRE) -- KYTHERA Biopharmaceuticals, Inc. (NASDAQ:KYTH) today announced it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for KYTH-105 (setipiprant) for treatment of androgenetic alopecia (Androgenetic Alopecia), or male pattern hair loss.

​

KYTHERA plans to conduct a human proof-of-concept study to evaluate the efficacy and safety of setipiprant in male subjects with Androgenetic Alopecia, an inherited genetic disorder that is characterized by a recession of the hairline, hair thinning and progression to partial or complete baldness in men.[SUP]i[/SUP] Studies have shown that Androgenetic Alopecia has a significant impact on self-image, and men with the condition are likely to suffer from
psychosocial complications including depression, low self-esteem, an altered self-image and less frequent social engagement.[SUP]ii[/SUP] With more than 35 million American men experiencing hair loss,[SUP]iii[/SUP] the demand for a safe and effective treatment remains high.



"This submission is a significant milestone in the development of KYTH-105 for male pattern hair loss," said
Frederick Beddingfield, III, M.D., Ph.D., KYTHERA Chief Medical Officer. "KYTH-105 represents a unique scientific approach to the treatment of hair loss that has the potential to help millions of men achieve a positive self-image."

Setipiprant is a selective oral antagonist of the prostaglandin D[SUB]2[/SUB] (PGD[SUB]2[/SUB]) receptor - a possible key variable in hair loss - and is a well-characterized molecule supported by a large safety database. Setipiprant has been previously evaluated by Actelion Pharmaceuticals Ltd. in nine clinical studies as a potential allergic inflammation treatment, including a Phase III trial in seasonal allergic rhinitis patients and a Phase II proof-of-concept study in asthma patients, resulting in a safety database of more than 1,000 patients with no safety issues identified.

More on the link, but sounds like a good sign. Hopefully we see some results from guys who have already taken this soon.

 

[FWIW]

Its first step to begin clinical trials.

 

[Dench57]

We all know it's safe. Let's see the efficacy!

I'm sure the people sourcing it across the forums will be able to give us an indication before Kythera's trials anyway.

 

[bald7802]

wow,Good News!!
Thanx..

 

[Ziggyz123]

Im actually not sure at all, since these people consume more than half the so called efficient dosage.

People ARE seeing classic signs of male pattern baldness become mitigated. I can't wait to trial SETI.

 

[Dench57]

If this works

That's the issue. I admire your optimism though. I've no doubt that PGD2 inhibition is beneficial for hair. The question remains how effective Setipiprant will be in doing that - we'll know in the coming months. Users of the first group buy are already reporting positive things: reduction in shedding, reduction of itch, hair and scalp looking and feeling healthier. I think it's the best thing to come along since RU.

It's too early to say if it will be a viable alternative to finasteride in terms of efficacy, but it looks safer. At best it will be as good as finasteride, at worst it will be a worthy addition to an existing regimen. Then you've got PGE2 which is equally exciting potential for thickening and regrowth.

 

[g.i joey]

Bruh this made my dick hard (and I'm on finasteride)

 

[wilson2]

Bruh this made my dick hard (and I'm on finasteride)

Joey your back on finasteride, you savage!

But yeah this looks promising.

 

[g.i joey]

Yeah man this is my best run yet

 

[Dench57]

I would like to know where did you bring this from.

A private forum that runs group buys for Setipiprant.

 

[username425]

Bruh this made my dick hard (and I'm on finasteride)

Best comment I've seen on this forum.

 

[M.G]

If this turns out successfull, about when will this be publically available?

 

[Jaym]

How long does it take for the FDA to approve the IND?

 

[Dench57]

Unfortunately, we won't really have an idea if this Seti works. The members that use it use it for 1-2 months so far, most of them with very low dosages and combined to other components in their regimen. So even if they report some certain things, we can't be sure if this is a derivative of Seti. Im still dying as **** to hear from them, but Im not sure how to take their reports. Only the results of phase II will really shed some light on this.. and it's gonna be long time from now

You'll have a rough idea from the reports of users in the next few months. I won't be using any other "maintenance" treatments (5ARi or AA), just some growth factors, but I'll know if Seti is helping because of my intense itch/burn where I'm losing hair. There's plenty of others using Seti alone too. Obviously, you'll get a much clearer idea when the Phase II results are released but that's way off.

 

[abcdefg]

The itch/burning has no proven link to male pattern baldness. A treatment might work even though you still have the itch.

- - - Updated - - -

Read: http://www.hairlosstalk.com/interac...-Setipiprant?p=1265527&viewfull=1#post1265527

I didnt really see any timeline or good idea of when it would be finished in this anywhere unless I missed it. It is a pretty big development that they are moving forward with this and hopefully they are going to move quickly. I think even the pessimists would have a hard time arguing all the stuff in the next 2-3 years is all going fail, or not get finished. There are like 4-5 things coming in the next 2-3 years all with pretty sound theories they should work from different angles. Although I still think hair loss prevention is much more likely than Norwood 6 to Norwood 1.

 

[Dench57]

The itch/burning has no proven link to male pattern baldness. A treatment might work even though you still have the itch.

Of course. I remember reading that only something like 2%-5% of people with Androgenetic Alopecia experience physical sensations along with their hairloss. I certainly never did before trying finasteride back last November. I think we can all accept that itching, burning, greasy hair is a sign that your hair is being attacked. So any treatment that reduces that is clearly doing something to help.

I didnt really see any timeline or good idea of when it would be finished in this anywhere unless I missed it. It is a pretty big development that they are moving forward with this and hopefully they are going to move quickly. I think even the pessimists would have a hard time arguing all the stuff in the next 2-3 years is all going fail, or not get finished. There are like 4-5 things coming in the next 2-3 years all with pretty sound theories they should work from different angles. Although I still think hair loss prevention is much more likely than Norwood 6 to Norwood 1.

Yeah I think the next few years are looking promising. I know this is a cliché in the hairloss community. I'm just talking about viable alternatives to finasteride and minoxidil for maintenance/thickening, not the silver bullet "cure" that these NW5s want to regrow their teenage hair.

 

[Dench57]

Hmm, you can help your hair in many ways. It doesn't mean you prevent hair loss. I would not take the less itching issue as a sign of stop of hair loss.

Less inflammation in the scalp/follicles is going to better for hair. I didn't say it would stop hair loss.

 

[Ziggyz123]

Less inflammation in the scalp/follicles is going to better for hair. I didn't say it would stop hair loss.

True. Another reason why finasteride/dutasteride don't work for everyone because it clearly isn't the main issue. We'll know soon enough. I have faith in the science behind this drug.

- - - Updated - - -

Hmm, you can help your hair in many ways. It doesn't mean you prevent hair loss. I would not take the less itching issue as a sign of stop of hair loss.

Honestly, it really isn't normal to have itching skin anywhere. When I'm sitting home doing nothing, my hands and legs aren't randomly itching.. You itch when there is an allergy or irritation to something. Everyone thinks it's "normal" to have itching on your scalp when it really isn't.
Itch relief most definitely is a positive sign for hair growth.

 

[Swoop]

Honestly, it really isn't normal to have itching skin anywhere. When I'm sitting home doing nothing, my hands and legs aren't randomly itching.. You itch when there is an allergy or irritation to something. Everyone thinks it's "normal" to have itching on your scalp when it really isn't.
Itch relief most definitely is a positive sign for hair growth.

That's a short assumption to make. Chongy is right the lack of itching or the relieve of itching says nothing. You could apply one of the most potent glucocorticoids for instance bethamethasone and be totally or partially relieved of itching. Your scalp will feel great and awesome. Yet your hair on your scalp will say goodbye and you will continue to lose hair.

 

[Dench57]

That's a short assumption to make. Chongy is right the lack of itching or the relieve of itching says nothing. You could apply one of the most potent glucocorticoids for instance bethamethasone and be totally or partially relieved of itching. Your scalp will feel great and awesome. Yet your hair on your scalp will say goodbye and you will continue to lose hair.

We're talking in terms of Androgenetic Alopecia though. And using Androgenetic Alopecia treatments. I've tried every cortico out there, including clobesol propionate which is far stronger than beta, and it does not relieve my Androgenetic Alopecia inflammation. Probably because it's constantly stimulated by DHT, you need to be constantly inhibiting that inflammatory stimulant (whether thats 5ARi, AA or potentially CRTH2). Most people's Androgenetic Alopecia inflammation is relieved when they start on finasteride/dutasteride/RU/CB whatever. It's always a positive sign because it means less androgen mediated inflammation and therefore less damage to the hair follicle.