Samumed Phase 3: Readout Expected No Earlier Than 2020

[Tomtom21]

We all know samumeds statted phase three for sm04554 but the trial has finally posted on clinicaltrials.gov:

2 Takeaways:
1. Well have a trial showing efficacy of both strengths of sm04554 for 48 weeks of daily use instead of only 13 weeks of active treatment.

2. The trial will be conducted in Turkey, include 675 people, and will not end until at least 2020.

Find the trial here:
https://clinicaltrials.gov/ct2/show/NCT03742518?term=Sm04554&rank=1

 

[alibaba92]

Until then, either take finasteride or pray for Shiseido.

 

[Kagaho]

We all know samumeds statted phase three for sm04554 but the trial has finally posted on clinicaltrials.gov:

2 Takeaways:
1. Well have a trial showing efficacy of both strengths of sm04554 for 48 weeks of daily use instead of only 13 weeks of active treatment.

2. The trial will be conducted in Turkey, include 675 people, and will not end until at least 2020.

Find the trial here:
https://clinicaltrials.gov/ct2/show/NCT03742518?term=Sm04554&rank=1

This is THE compound i want to add to my dermarolling regimen.

Lets hope its safe.

 

[Taep]

Until then, either take finasteride or pray for Shiseido.

Will RCH01 be released in 2019? Can I have hope?

 

[JimmyB]

What does the trial being in Turkey mean for US residents? We're basically at 2019 so 2020 isn't so far off. Samumed has been one of the few companies to move quickly, so lets hope they don't keep facing delays.

 

[Yepesyellow]

If it is a 48 week trial it probably will not conclude until early 2020, then factor in another few months for compiling data and lastly nine to twelve months for FDA/ EMA clearance; assuming positive results, a late-2021/ early-2022 release is probably a fair estimate.

 

[Kagaho]

Here is the official press release posted on their website:

https://www.samumed.com/medium/imag...atment-of-androgenetic-alopecia_503/view.aspx

 

[distracted]

Why do we still care about Samumed? Their last released results from like 2 years ago were so underwhelming...I'm surprised they haven't totally abandoned this.

 

[tomJ]

Why do we still care about Samumed? Their last released results from like 2 years ago were so underwhelming...I'm surprised they haven't totally abandoned this.

Well that's easy...because there isn't much else.

 

[JimmyB]

Why do we still care about Samumed? Their last released results from like 2 years ago were so underwhelming...I'm surprised they haven't totally abandoned this.

They clearly see potential if it's going into phase 3. Don't think they'd be wasting tons of money and time pushing something that likely won't work. And it's possible it will work better with some sort of dermarolling or Follica like product.

I'm just wondering why they're calling it phase 2/3...makes me think it's not a "true" Phase 3. I know they wanted to potentially redo phase II, so maybe this is some sort of combined trial?

 

[Kagaho]

And it's possible it will work better with some sort of dermarolling or Follica like product.

This. The mechanism of action has potential as it can be synergistic with wounding techniques.

 

[Leto]

Were there any other drugs in the last 20 years that got into phase 3?

 

[tomJ]

I dont understand why allergan isn't giving us any feedback on bim or setipiprant trials. The trials have been completed for a while now and they since have been removed from their pipeline I hear...I'd like to know why? Allergan prides itself on communication. I disagree. Did it lack effectiveness? Was their health risks? Too costly of a medicine? They really should tell the public the reason as many guys buy this stuff online to try for themselves. I dont think they would try it if they knew there was a serious potential for harm to their body or lack of effectiveness during the professional trial. Seriously I get riffed when companies advertise their drug and then go quiet. Public has a right to know for their own well being!

 

[alibaba92]

Here is the official press release posted on their website:

https://www.samumed.com/medium/imag...atment-of-androgenetic-alopecia_503/view.aspx

Why phase 2 / 3 and not phase 3 ? Do you have any idea ? Is it the final phase before filing for approval yet ?

 

[tomJ]

Why phase 2 / 3 and not phase 3 ? Do you have any idea ? Is it the final phase before filing for approval yet ?

It won't be out til 2022 the earliest.

 

[JimmyB]

Why phase 2 / 3 and not phase 3 ? Do you have any idea ? Is it the final phase before filing for approval yet ?

I bet they're redoing part of phase II as part of the trial. They previously mentioned wanting to refine their product before moving into phase III, and it's possible that would have required another separate Phase II in the US. I'd bet that's why it's being done in Turkey as well.

 

[soull]

I guess refining would be in phase 3, right? the important thing would be to know the duration of this "phase 2/3"

 

[Screeech]

I bet they're redoing part of phase II as part of the trial. They previously mentioned wanting to refine their product before moving into phase III, and it's possible that would have required another separate Phase II in the US. I'd bet that's why it's being done in Turkey as well.

"Refining" would be adjusting the dosage amount, right, and not the actual molecular make-up, if that is the right parlance?

 

[kiwi666]

"Refining" would be adjusting the dosage amount, right, and not the actual molecular make-up, if that is the right parlance?

Correct. Upping the dose means they have to retest safety. Such a slow process

 

[tomJ]

I just hope that it will be available in US when it becomes available in turkey.