Sm04554

[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]

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

[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)?

[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.

[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?

[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.

[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.

[candu2015]

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.

I follow with great interest this product, it's a different approach.
I am very hopeful that this treatment will come soon.
It seems they already have chosen the 0.25%?
What do you think?
I'm sorry for my English

[Seuxin]

I really would like to know too the timeline of this SM !

[unbalding]

If anyone is in Texas, Ohio, Virginia, or Michigan, they are still recruiting participants.
https://clinicaltrials.gov/ct2/show/...ank=1#contacts