Published in Nature: Weekly treatment with SAMiRNA targeting the androgen receptor ameliorates androgenetic alopecia

Ralph Wiggum

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In the high-dose (5 mg/ml) clinical study, AR68 was given once per week for 24 weeks and showed 83% efficacy in increasing hair counts compared with finasteride. No side effects were observed. Therefore, SAMiRNA targeting AR mRNA is a potential novel topical treatment for Androgenetic Alopecia.
 

Solid_Snake

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Wait so this targets the receptor instead of lowering DHT, right?

Therefore, could it be used in conjunction with finasteride/dutasteride for better maintenance?
 

nick123

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I just came across this new study too.

At 24 weeks the high dose (5mg/ml) AR68 maintained just above baseline in both hair density and total hair count, the pictures in my opinion are not massively impressive but technically it did maintain at 24 weeks.

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The most interesting thing for me here actually is that they label AR68 as a COSMETIC.

"For the development of Androgenetic Alopecia treatment using AR68, AR68 (Cosmerna-68) is listed as a cosmetic ingredient in cosmetic ingredients (ICID) and the Cosmetic Ingredient Dictionary, which are reviewed by the PCPC (Personal Care Products Council) and KCA (Korea Cosmetic Association), respectively. The stability of AR68 nanoparticles in a hair tonic formulation containing cosmetic ingredients was studied by measuring the size of AR68 nanoparticles that remained stable for more than six months."

A cosmetic potentially means that it can skip the long clinical trial process and we can get our hands on it sooner rather than later.

This is just an assumption but since this decreases the expression of AR mRNA and protein levels, I feel like this treatment won't massively plateau like other drugs that target the AR such as androgen receptor antagonists (Breezula)..

It appears they may be trying to enter the US market as a cosmetic:

"Aside from Bioneer’s progress within the domestic and the European markets for hair loss prevention, siRNAgen is preparing for the U.S. market entrance of CosmeRNA as a hair loss treatment. The existing mechanism, its safety and efficacy shown through human clinical trials were presented during the conference and received many attention from participating companies and investors. The siRNAgen plans to further improve the product profile for the U.S. market in particular, as the product will be developed beyond cosmeceutical use."

Product website:
Sources:
 
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rocket_hare

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Yeah I saw the name is Cosmerna-68.

I'm wondering if this can be bought commercially already from a compounding pharmacy or similar.
 

nick123

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It's nothing spectaculair that's for sure.

Efficacy isn't massively spectular no, but I think the point here is:

1) It's stackable with 5ARIs and other anti-androgens for extra protection
2) It's only a weekly treatment
3) It's a cosmetic which means it doesn't have to go through 3 phases of clinical trials so hopefully we get our hands on it sooner rather than later
 
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trialAcc

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This would be for maintenance and hypothetically increase the shelf life of finasteride by years. Seems great if it can just hit the market quickly.
 

nick123

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I would like to remind everyone not to get overexcited, as there was another cosmetic a few years ago named "Brotzu's lotion" and we all know how that went...

That being said, this product actually has 2 registered clinical trials and a published study so it's already massively up on Brotzu / Trinov
 

Baldingtooyoung

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80% as effective as finasteride with no sides, and can be combined with finasteride synergistically.

This is very exciting. Think of it this way: at the end of this year, you may be able to stack finasteride, this, and/or pyrilutamide.
We haven't seen one result yet for Pyralutimide. This treatment will be likely expensive asf as well
 

GotHair?

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Do note that they were administered this for 24 weeks it could have long term potential with no serious side effects so far.
Let us hope this will be available. I would buy it just to test it out. And as others have said you can add it to big three.
 

trialAcc

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There's no way the FDA/EMA will allow an mRNA silencer to be marketed as a cosmetic.
I feel like you're just picking out the buzz word here and thinking that it's some new dangerous frontier of science. These guys already demonstrated they can do a cosmetic approach by the manor of trial they used. They basically did a full phase 3 trial before any phase1/2.
 
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Redgate

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I feel like you're just picking out the buzz word here and thinking that it's some new dangerous frontier of science. These guys already demonstrated they can do a cosmetic approach by the manor of trial they used. They basically did a full phase 3 trial before any phase1/2.
I don't think it's a dangerous frontier of science, but it's not make-up or skin moisturizer either. How can it escape drug classification? Why can't other AR antagonists?
 

Kagaho

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I have mixed feelings about this. Sincerely i was expecting more from this MOA. It seems downregulating AR expression its not going to be superior to finasteride/dutasteride in terms of hair growth.

On the bright side, its a good adjunct to current antiandrogen therapies and a very convinient dosing frequency.
 

Armando Jose

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"Nanoparticles can be more efficiently delivered to hair follicles than small molecules through the pumping effect of massage after application"

IMO, No regrowth but maintenace due at massaging scalp 3 times a week.
 

hmmmmmmmm

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There's no way the FDA/EMA will allow an mRNA silencer to be marketed as a cosmetic.
yeah it seems very obvious that the FDA shouldn't accept it as a cosmetic ingredient

but that really begs the question about how it got such a designation in Korea and whether this gut reaction is missing something...

it's clearly a drug whose express purpose is to treat a medical condition with a novel ingredient, in a novel fashion, with nothing similar enough in the market to borrow an established safety profile from

only 3 siRNA drugs have ever been approved by the FDA, the first being just over 3 years ago, and this category of drug has shown a history of possible accumulation in the liver and of triggering immune responses

those 2 Korean studies might qualify it to go straight into phase III if they're forced to file an IND, at which point we're talking 3+ years to approval in the best case

I suspect it'd be available for years via import before you ever see it at a CVS or Walgreens, will be interesting to follow
 

5minutesbeforemiracle

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only 3 siRNA drugs have ever been approved by the FDA, the first being just over 3 years ago, and this category of drug has shown a history of possible accumulation in the liver and of triggering immune responses
In the paper, they claim this formulation doesn't elicit an immune response.

Anyway, looks like they are currently doing another trial in Germany. See pic attached, a presentation from Bioneer's (siRNAgen's parent company) presentation.
 

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hmmmmmmmm

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In the paper, they claim this formulation doesn't elicit an immune response.

Anyway, looks like they are currently doing another trial in Germany. See pic attached, a presentation from Bioneer's (siRNAgen's parent company) presentation.
Thanks, I guess the German trial is one of the big events to watch

Completely plausible there's no immune response, but the fact that it was even something to have to rule out is why I believe the FDA will not be willing to regulate it as a cosmetic, and why they'll require a much larger human trial (which the German one might be?)

In terms of their optimism for time to market, it may also be a bit of fluff they're feeding their investors to make it seem like they're far ahead of companies like OliX who have very similar approaches https://www.globenewswire.com/news-...tigational-Hair-Loss-Therapeutic-OLX104C.html
 
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