Sm04554

[lacazette]

Hey good find thanks Candu . The first ever trial of SM was in australia, they have facilities there
that new micro trial is interesting, it adds some safety biomarkers and seems they had choose a define protocol

Daily topical application of 0.25% (w/v) solution of SM04554 to scalp for 14 days.
SM04554 is supplied as in a non-aqueous solution of PEG400 at concentration of 0.25% weight per volume (w/v);1 vial of 0.5mL
Subject will apply at least 0.3mL of a 0.5mL study drug (SM04554) at site during visits under supervision of site staff.


Primary outcome
To characterise pharmacokinetics of topically applied 0.25% SM04554 solution to male subjects with androgenetic alopecia, estimated using available concentration-time data for Cmax, tmax, AUC (0-24), AUC (0-infinite time) and t(1/2) from collected blood samples.
Timepoint
On treatment days 1 and 14 blood samples will be taken prior to study drug application and at 1, 2, 4, 6, 12 and 24 hours post study drug application.

On treatment days 5 and 10 blood samples will be taken prior to study drug application only.
Secondary outcome
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by changes from baseline in vital signs, clinical laboratory parameters and electrocardiography(ECG)
Timepoint
ECG: days 1 and 14 prior and 4 hour post study treatment
Vital signs: screening day, days 1, to 14 prior to study treatment, on days 1 and 14 at 4 and 12 hours post study treatment. ECG also performed at follow up visit day 15.
Clinical chemistry, haematology parameters and urinalysis: screening day and day 14 prior to study treatment and day 15 post study treatment
Secondary outcome
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by adverse events (such as skin irritation (erythema,scaling puritis, stinging) , eye irritation) and assessed by medically qualified study staff.
Timepoint
Every day from first day study drug application to day 14 and at end of study day 15.
Secondary outcome
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by investigator skin assessment of the scalp and hands.

[bboy5]

Can anyone please answer this; if this latest SM trial is successful and they move to phase 3, how long does phase 3 for a hair loss med take?
I heard ppl say that bim could have moved through phase 3 in 6 months...is it the same timline for SM?
Is there anyway in hell this could be available in the next year (if it works of course)?

It's already available, we just don't know if it works. If the trail show's good evidence Seti works then why would you wait? Group buys and purity testing are all we need, if even that.

[candu2015]

hello it is the first time I write here but I have a lot of time reading to them.
Has anyone seen this trial about SM? https://www.anzctr.org.au/Trial/Regi...aspx?id=368801

why this trial in australia?

[allTheGoodNamesAreTaken]

Can anyone please answer this; if this latest SM trial is successful and they move to phase 3, how long does phase 3 for a hair loss med take?
I heard ppl say that bim could have moved through phase 3 in 6 months...is it the same timline for SM?
Is there anyway in hell this could be available in the next year (if it works of course)?

Based on how slow EVERYTHING seems to move in this business I wouldn't count on the earliest possible release date turning out to be the actual one. Just assume it's gonna take ages to get released if it works at all.

[champpy]

Can anyone please answer this; if this latest SM trial is successful and they move to phase 3, how long does phase 3 for a hair loss med take?
I heard ppl say that bim could have moved through phase 3 in 6 months...is it the same timline for SM?
Is there anyway in hell this could be available in the next year (if it works of course)?

[lacazette]

yeah the temp approval and new legislations are for regenerative medecine BUT when it comes to drugs approval, the process is also quicker and easier in Japan than US and EU

[JayM]

Agreed nameless

And I would add that they're surely planning to hit the asian market by japan's approval

The drug approval is already easier there, and even more easier when it comes to a topical drug instead of an oral
So I suspect a second phase 2 with detailed biomarkers could be sufficient to ask for Japan's FDA approval

I thought Japan early release was only for stem cell therapies?

[lacazette]

Agreed nameless

And I would add that they're surely planning to hit the asian market by japan's approval

The drug approval is already easier there, and even more easier when it comes to a topical drug instead of an oral
So I suspect a second phase 2 with detailed biomarkers could be sufficient to ask for Japan's FDA approval

[nameless]

I hope you're right

Don't misquote me. I said I'm not 100% sure.

That having been said, I do not believe that the company intended to do the supplemental phase 2 from the beginning because if they had intended to do the supplemental phase 2 all along then it seems logical that they would have done it as part of the original phase 2. They could have gotten biopsies from their subjects in the original phase 2 study.

So this makes it look to me like this supplemental phase 2 study is something they only recently decided to do.

So the big question is what could have prompted them to do this ad-hoc study which will produce bio-markers? I think that the logical answer to that question is that they're aware of the new FDA law that allows drug companies to use bio-markers in lieu of a phase 3 study.

I also think that this ad-hoc study also makes it seem like they got good results in their original phase 2 study because why would they spend millions of dollars on the ad-hoc supplemental phase 2 study if they didn't see something promising in the original phase 2 study?

[joel203]

I'm not 100% sure but I think you're probably wrong. I even think that the company believes that their drug will be affected by the new law or else the company would not bother trying to secure biomarkers through their additional phase 2 study. I think there's a very real possibility that they hope to use biomarkers in lieu of a phase 3.

I hope you're right

[nameless]

agreed

I'm not 100% sure but I think you're probably wrong. I even think that the company believes that their drug will be affected by the new law or else the company would not bother trying to secure biomarkers through their additional phase 2 study. I think there's a very real possibility that they hope to use biomarkers in lieu of a phase 3.

[TooMuchHairWontKillYou]

better worry about efficacy

If SM fails I will get TE from depression

[lacazette]

I read some various articles, saying that the new laws will give so much more freedom to pharma companies and that it will be very dangerous for the safety of the population. And that it would be better to stay like this without especially the suppression of the long phase 3 replaced by biomarkers,etc

So if the bill pass, I don't see why we should be afraid for hairloss drugs as the other cosmetic areas. pharma freedom is all we need. And pharma lobbies are for sure already doing their job to make this bill passed, so no worries to have i think

[It's2014ComeOnAlready]

Yeah a lot of talk about this bill but no one has any clue what it will really do for specific drugs until they actually start altering timelines and there is a basis to start guessing at other ones. Right now it might not do anything at all for cosmetic drugs. No one knows. I wouldnt count on politicians or laws they pass to do much of anything in speeding up trials. Waiting on new treatments for many years is the worst part of the whole thing especially stuff like CB when there are millions of previous AAs some with similar actions to base safety off of yet 5 years to finish it? I doubt getting a topical delivery system takes that long to do. The phase 3 just kills huge amounts of time and money

I don't think it's OK to speculate one way or another. You all seem to go according to your mood. The bottom line is that this law will change some protocol for clinical trials in general. They want to add information, i.e. biomarkers and surrogate endpoints. This is as much a health bill as it is an economic one. The point of the bill is also meant to keep innovation in the United States.

Of course all of you believe hair loss will be left out. It's all I hear about on this board. How about keeping a positive outlook for once?

Enough talk, let's just wait and see.

[joel203]

Im not very familiarized with US law but find really unlikely this act will speed up clinical trials for hairloss drugs.

agreed