Sm04554

[xyz123]

It appears that Samumed has launched a second Phase 2 trial for SM04554 that includes scalp biopsies to try and clarify its mechanism of action. The study size is smaller relative to the initial Phase 2 study (50 vs 300).

https://clinicaltrials.gov/ct2/show/...sm04554&rank=1

Although purely speculative, this may be a good sign - if there was no signal of efficacy in the original study, then I think it's unlikely that they'd do a follow-up mechanistic study. Hopefully it's an indication that that the results are promising (to note, the original study is still not finished - timeline set for October, 2015). So who knows - maybe they are pleased with the results and want to try and clarify the mechanism of action before launching a Phase 3 study.

If the results are impressive - this could end up being a great topical. The follow-up time in these studies is 90 days - so if it works, it works pretty quickly. And the primary endpoint in the scalp biopsy study is a change in the number of hair bulbs - which may imply that the investigators are anticipating that the drug was successful at triggering follicular neogenesis. The inclusion criteria for the study was NW 4-6, so they were clearly focused on regrowth.

Lastly - others had suggested that the US Army was running a hair loss trial using a topical out of Wake Forest in Winstom-Salem. However, Winston-Salem is a site for the initial SM04554 Phase 2 study - so I suspect SM04554 is the topical being investigated - and not a US Army initiative.

[xyz123]

It appears that Samumed

[JayM]

I assume the biopsies will be 50 from the original 300? I'm intrigued a lot about this but they could have been going to do this anyway.

[JayM]

Oh I just realised they are actually recruiting. Does anyone live near them?! Man I wish I lives in America.

[xyz123]

Fair point. The scalp biopsies have to be done before and after treatment. There was no indication in the original study that they were doing scalp biopsies - and if they weren't done pre-treatment, then they can't use the same people. The new study is listed as "currently recruiting participants" which implies that they are looking for new people. Given that this is something that really needs to be done prospectively - I think it's a bona fide new trial - but of course, can't be certain.

[JayM]

I'm still on the fence though whether this is good news or bad. I guess they wouldn't bother doing this if they didn't see results. But then again maybe they didn't and want to see if anything did happen to the follicles? hmm but then I also assume they saw at least something in the phase 1 to carry onto phase 2? aha oh man anyone on here like an expert on trials and might know whats happening?

[xyz123]

I don't think it's possible to know for certain. However if they saw no results, I really can't see them launching another study to try to explain negative results. They're a relatively small biotech company - if the results were negative, I think they'd cut their losses and move on. As someone else highlighted, it's interesting that they are a Silver sponsor of the WCH - that's a big investment for a relatively small biotech company. Their initial Phase 2 trial is scheduled to finish in October - so the timing would be good for them to announce their (hopefully impressive) results at WCH in November.

Who knows - with the anticipated passing of the 21st century cures act, maybe this modified Phase 2 trial is being designed to provide additional surrogate outcome data to avoid having to complete a full Phase 3 trial before coming to market. That said - although the 90 day primary outcome is impressive with regards to the potential quick impact of the treatment - it's odd that they don't have longer follow-up included as well - ? 1 year - for both efficacy and safety purposes.

[nameless]

It appears that Samumed has launched a second Phase 2 trial for SM04554 that includes scalp biopsies to try and clarify its mechanism of action. The study size is smaller relative to the initial Phase 2 study (50 vs 300).

https://clinicaltrials.gov/ct2/show/...sm04554&rank=1

Although purely speculative, this may be a good sign - if there was no signal of efficacy in the original study, then I think it's unlikely that they'd do a follow-up mechanistic study. Hopefully it's an indication that that the results are promising (to note, the original study is still not finished - timeline set for October, 2015). So who knows - maybe they are pleased with the results and want to try and clarify the mechanism of action before launching a Phase 3 study.

If the results are impressive - this could end up being a great topical. The follow-up time in these studies is 90 days - so if it works, it works pretty quickly. And the primary endpoint in the scalp biopsy study is a change in the number of hair bulbs - which may imply that the investigators are anticipating that the drug was successful at triggering follicular neogenesis. The inclusion criteria for the study was NW 4-6, so they were clearly focused on regrowth.

Lastly - others had suggested that the US Army was running a hair loss trial using a topical out of Wake Forest in Winstom-Salem. However, Winston-Salem is a site for the initial SM04554 Phase 2 study - so I suspect SM04554 is the topical being investigated - and not a US Army initiative.

Man, this is good news and your analysis is spot on. I'm not 100% sure that the drug works yet but things are looking pretty positive. You are absolutely right that it's highly unlikely that they would even bother with this special phase 2 unless they were seeing good results and the fact that they are using only NW 4-6 also is highly indicative that they are seeing regrowth. It's not 100% certain but it's looking very VERY good.

We need to send Hellouser to the 2015 hair loss congress and he needs to interview the lead temporary contract researcher (Wilma Bergfeld) AND whoever Samumed sends from it's permanent staff to act as their spokesman. If he goes in prepared he could probably get it from them which is the correct compound in the patent and then we could possibly get it made. Otherwise we wait 3 years.

[breakbot]

I'm a negative-non optimistic poster but i believe this drug is something huge.
It's obvious if they didn't see results that they wouldn't bother to add another trial, which means more money.
I think better days are coming....

[JayM]

Is there a specific time frame a phase 3 trial has to go through? I mean of they are going to do this after a 90 day period then that bodes well if there is no limit.

Also would they do this if it wasn't for the 21st century cure act? Like that's a genuine question I'm no expert.