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/NCT02503137?term=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]

Second Phase 2 trial for SM04554

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/NCT02503137?term=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.

[It's2014ComeOnAlready]

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/NCT02503137?term=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.

Awesome find. Please post more.

[xyz123]

Yeah - I think the new Phase 2 trial is a good sign - but I guess we can't be totally certain. Given the short 90 day follow-up period - to play devil's advocate - I guess it's conceivable that they saw minimal results - however before cashing out after years of work and millions of dollars of investment, they're doing scalp biopsies to see if there are any sub-clinical positive changes occurring - which would indicate that they should invest in a longer follow-up period to try and detect cosmetically meaningful regrowth.

But I think this scenario is less likely - the objective of the study is supposed to be to determine the mechanism of action of SM04554 - so if it was not producing meaningful results, there would be no point in elucidating a mechanism of action and wasting money that could be spent on other drugs in their pipeline.

In addition to getting a better sense of the efficacy of the drug, the scalp biopsies may also be important for establishing safety. Given that the drug modulates the Wnt/beta-catenin pathway, it has the potential to be oncogenic (a history of skin cancer is an exclusion criterion for the study) - so the biopsy may also be looking for any potential signal of harm.

Lastly - although the drug is applied daily for the 3 month study period, I doubt that the vision is for the drug to be applied daily for an indefinite period given the concern that chronic upregulation of the Wnt/beta-catenin pathway could significantly increase your risk of cancer. Although speculating again - I suspect the idea is that the drug stimulates stem cells to activate/restore dormant and miniaturized follicles. Once you get adequate regrowth (and hence all of the necessary follicles working), you would stop the drug. But of course, although the follicles may be working again - they are still vulnerable to DHT - so you'd have to be on maintenance therapy to preserve your results (and hopefully seti can serve that role instead of fin in a few years... ). This concept is somewhat similar to the vision of the Follicept group - though I am much more optimistic about SM05445 than I am about IGF-1 alone (especially given that Histogen had relatively modest results with a product that included IGF-1, coupled with the relatively dismal results of Follicept thus far...). Consistent with this line of thinking, in the Phase 1 trial for SM04554, they only applied the drug for 14 days, but monitored for hair growth out to 28 days.

Hopefully hellouser can shed light on all of these issues when he goes to Miami. I'm really hoping Samumed reports their results at the congress - it would suck to have to wait, seemingly indefinitely, for the study results - which seems to be happening right now for bimatoprost. Although who knows what the future holds - I think that the only two new drugs we have a chance of seeing in the next 2-3 years in North America are SM04554 and bimatoprost - hopefully they come sooner than later...

[nameless]

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?

The phase 1 didn't involve a great deal of medication. They didn't apply very much. I doubt if they learnt much about hair growth from the phase 1. But I don't think they would be doing a special phase 2 to find out what is going on under the skin (biopsies) unless the FDA wanted to know exactly and specifically what effects the medicine is having under the skin so I think that the FDA probably demanded this special phase 2 study. And I don't think that Samumed would fund this extra study unless they saw something in the original phase 2 study that looked promising. I think that if the FDA ordered Samumed to do an additional phase 2, but the original phase 2 produced nothing positive, then Samumed would just kill the project. Why spend the money on the special phase 2 if the original phase 2 produced nothing positive?????


Then again, I think it's also possible that Samumed may have decided to do this study on their own (without the FDA mandating it) because Samumed saw no positive results above the skin so Samumed wants to find out if SM04554 is having any positive effects below the skin.

[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/NCT02503137?term=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.

One negative thing is that (if this drug works) this additional phase 2 will lengthen the timeline before it comes to market and so now if it works we will have to wait 4 years for it. All the more reason we should fund Hellouser's trip to the Congress under the condition that he will pursue interviews with the lead investigator (Wilma Bergfeld) and whatever Samumed staff-person that Samumed sends to the Congress so that he might secure information about which compound in the SM04554 is the correct drug.

[It's2014ComeOnAlready]

I'm honestly confused. I think it's positive, because they're spending more money to get more data. But, why weren't they measuring these things in the first place? Why the need for additional studies?