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Research: Novan Sb204 To Treat Acne + Oily Skin

MemberMember
2
(@pooratbest)

Posted : 06/07/2013 10:49 am

Hi guys, i'm really surprised not to read any stuff about this new cream that's currently in its testing phase. Produced by a research lab called 'Novan', here are a couple of articles (you can find plenty of press releases on it from the last couple of months).

[Edited link out]

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How it works (white paper).pdf file

Obviously it's a little way to go on it's testing yet, and I can think of one or two instances where I've seen drugs companies develop acne meds and then never release them to market - but with the pressure mounting against Accutane you never know this could be the time. Keep your fingers crossed that it goes well, it's time that modern medicine sorted this acne cr*p out once and for all!

I wish I knew a way to show some support to these guys, I hope they look around at forums like this one and see how many be they'd help and how enormous their potential market (and profit margin!) could be.

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Guest
0
(@Anonymous)

Posted : 06/07/2013 2:53 pm

This actually looks fairly legit. It's the first time I've heard of an NO(2) compound being used to treat oily skin, I'm curious as to how this turns out.

 

Unfortunately, it's probably less than 50% through the testing phase, by the time this hits the market for the general public I'll be married LOL

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MemberMember
2
(@pooratbest)

Posted : 06/08/2013 3:57 am

It's testing phase is expected to be completed in 2014, which sounds great - I'm guessing medical products have to go through a few more safety tests before they can be marketed but you never know, perhaps in 3 years time we'll all be slathering this stuff on our clear skin! It's just nice to have a bit of hope for once.

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0
(@Anonymous)

Posted : 06/08/2013 8:13 am

Oh really? That's great. I thought it still didn't get to Phase III testing yet, which is a clinical trial on actual patients.

 

Good to hear they are moving it along though.

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MemberMember
2
(@pooratbest)

Posted : 06/10/2013 4:50 am

I don't know much about the phases of testing, but I think every phase after the first is on people, using a bigger group each time, so like phase 2 might have 10 people, phase 3 100 and phase 4 1000, at least I think that's how it works.

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Guest
0
(@Anonymous)

Posted : 06/10/2013 10:58 am

Pretty much. This website explains it well

https://www.breastcancer.org/treatment/clinical_trials/phases

But what it means though is the first two phases mean little because the sample size is so small.

Most consider the Phase III trial to be the definitive one though, because it has such a large sample size and the efficacy of the drug in comparison to others in checked. Phase III is unfortunately where most drugs fail.

I don't know where this drug is exactly, but I read they mentioned in-vivo and in-vitro testing; this is sometimes called Phase 0. It has to be farther along though because I doubt it'd have made news otherwise lol.

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MemberMember
2
(@pooratbest)

Posted : 06/14/2013 4:35 am

Just thought i'd post a link to the patent, here. It's got a brief outline of what the medicine hopes to achieve:

1. A method of decreasing sebum production in skin of a subject comprising applying nitric oxide and/or at least one nitric oxide source to the skin in an amount sufficient to decrease sebum production.
2. The method of claim 1, wherein the sebum production in the skin is decreased by applying gaseous nitric oxide to the skin of the subject.
3. The method of claim 1 , wherein the sebum production in the skin is decreased by applying at least one nitric oxide source to the skin of the subject.
4. The method of claim 3, wherein the at least one nitric oxide source comprises a nitric oxide (NO)-releasing compound.
5. The method of claim 4, wherein the NO-releasing compound comprises a small molecule NO-releasing compound.
6. The method of claim 4, wherein the NO-releasing compound comprises a macromolecular NO-releasing compound.
7. The method of claim 6, wherein the macromolecular NO-releasing compound comprises N-diazeniumdiolate-functionalized macromolecules.
8. The method of claim 7, wherein the N-diazeniumdiolate-functionalized macromolecules comprise N-diazeniumdiolate co-condensed polysiloxane macromolecules.
9. The method of claim 6, wherein the macromolecular NO-releasing compound comprises nitrosothiol-functionalized macromolecules.
10. The method of claim 4, wherein the NO-releasing compound is present in a pharmaceutically acceptable composition.
11. The method of claim 10, wherein the pharmaceutically acceptable composition comprises at least one other therapeutic agent.
12. The method of claim 1 , wherein the nitric oxide is applied at a concentration that is toxic production sites.
13. The method of claim 1, wherein the nitric oxide is applied at a concentration that is not toxic to sebum production sites.
14. The method of claim 1, wherein the nitric oxide is applied at a concentration that is preferentially toxic to sebum production sites over keratinocytes.
15. A method of decreasing sebum production in skin of a subject comprising systemically applying nitric oxide and/or at least one nitric oxide source to the subject in an amount sufficient to decrease sebum production in the skin.
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MemberMember
2
(@scientificapproach)

Posted : 07/29/2015 8:32 am

On 6/10/2013 at 9:58 PM, CBIOT13 said:

Most consider the Phase III trial to be the definitive one though, because it has such a large sample size and the efficacy of the drug in comparison to others in checked. Phase III is unfortunately where most drugs fail.

This doesn't appear to be correct. According to the following sources, the phase 2 is where most drugs are rejected:

http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm

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If you have better sources or reasons to believe that it's different for acne drugs, I'd be happy to read.

As for Novan's SB204, phase 2b clinical trial results are expected this quarter. It covers 200 patients. Phase 3 is expected to start in Q1 2016.

They have a shiny new website at http://www.novantherapeutics.com/ where they post news about the drug. I'm hopeless and skeptical about any new acne drugs (they take long years to go through clinical, most are scrapped at some point, and I have yet to see anything that delivers results comparable with isotretinoin), but I still follow this stuff because there's not much else I can do.

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MemberMember
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(@scientificapproach)

Posted : 10/11/2015 4:10 am

Phase 2b successful:

[Edited link out]

Phase 3 covering 2600 patients planned for Q1 2016.

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MemberMember
48
(@ben100604)

Posted : 01/11/2016 7:44 am

I've been keeping an eye on this drug too as it sounds very promising.

It's probably going to be a good 3 - 5 years before this is on the market, though, which is a bit frustrating!

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MemberMember
48
(@ben100604)

Posted : 01/16/2016 5:37 pm

I hope it does come that soon, but each phase of testing usually takes a couple of years. There's a lot of work involved, even if it does work perfectly well without side effects.

They're just about to commence Phase 3 testing for SB204 and after that they need to get approval for the drug from government bodies e.g the FDA. I reckon it's still going to be 3 - 5 years.

However, the fact remains that it's very exciting!

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MemberMember
2
(@scientificapproach)

Posted : 02/14/2016 2:36 am

Info about phase 3:
https://clinicaltrials.gov/ct2/show/NCT02667444
https://clinicaltrials.gov/ct2/show/NCT02672332

This is going to be a lengthy one:

Estimated Enrollment: 1300
Study Start Date: February 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: April 2017

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MemberMember
5
(@foggynotion)

Posted : 02/15/2016 7:49 am

Wow, really interesting and definitely worth to keep an eye out onto.

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MemberMember
48
(@ben100604)

Posted : 06/11/2016 4:50 am

Phase 3 will be complete in October 2017 and there will still be a lot of work required to get it to market. I'd be surprised if it's out before the end of 2018. And that's assuming it's sanctioned for public release by the authorities.

Hopefully it will make it. I'm just intrigued by it's anti-sebum properties. I've been oily since the 90s, so welcome being a little dryer!

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MemberMember
2
(@scientificapproach)

Posted : 01/29/2017 10:47 am

Sadly, things aren't looking good for SB204. The first trial failed, the other showed merely minor improvements: https://endpts.com/discordant-data-strikes-a-sour-note-for-novans-phiii-studies-of-a-new-acne-drug/

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