Samumed Sm04554 Results Normalized To Baseline

frank33

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Are you blind?

0.15% has a mean haircount increase of 10.1 per square cm over the period of 115 days.
0.25% has a mean haircount increase of 7.7 per square cm over the period of 115 days.

0.15% has a mean density increase of 336.4 per square cm over the period of 115 days.
0.25% has a mean density increase of 281.8 per square cm over the period of 115 days.

Also just to add in the phase 2 trials SM04554 was only actually applied for 90 days and then 25 days later the measurements were recorded..

Clincal Trial Source: https://www.clinicaltrials.gov/ct2/show/NCT02275351?term=SM04554&draw=2&rank=3
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Just one detail, it's 45 days after stopping the treatmebt and not 25
 

nick123

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Just one detail, it's 45 days after stopping the treatmebt and not 25
Have you got a source for that? The phase 2 results state measurements were recorded at day 115 and the phase 2 clinical trial was to apply SM04554 once daily for 90 days.
 

frank33

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Have you got a source for that? The phase 2 results state measurements were recorded at day 115 and the phase 2 clinical trial was to apply SM04554 once daily for 90 days.
You can look at the image Frenchboy posted, or at pag 1 of this thread
 

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nick123

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Gegen

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Sure but it's still further above vehicle and imo 135 days is a short amount of time for a treatment to see results, phase 3s 48 weeks should give us a better insight to how it compares to vehicle.
Oh yeah, 48 weeks of treatment + 6 weeks of follow-up, it will be another thing, slightly more consequent.
 

Dus

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So let's say everything goes well, what is a realistic timeline for a Turkey - EU - US release for this one?
 

Tom4362

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Samumed expects its phase 3 osteoarthritis study to read out by the end of 2020 and hopes to submit lorecivivint for FDA approval in the first quarter of 2021. Its alopecia treatment is close behind, with approval anticipated in late 2021 or early 2022

This was before it was known that the trial completion date would be delayed by 6 months
 

frank33

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How long have you been in this space bro? Ever seen companies actually deliver on time? I sure have not
This is some serious company, they managed to complete phase 3 studies despite covid19 where everyone else just delayed with no progess. I think SM will hit the market in turkey in 2022

But again, only speculations, we don't know enough.
 

Tom4362

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This is some serious company, they managed to complete phase 3 studies despite covid19 where everyone else just delayed with no progess. I think SM will hit the market in turkey in 2022

But again, only speculations, we don't know enough.
I sure hope so
 

nick123

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This is some serious company, they managed to complete phase 3 studies despite covid19 where everyone else just delayed with no progess. I think SM will hit the market in turkey in 2022

But again, only speculations, we don't know enough.

Agreed, whether SM04554 is efficacious or safe long term or not you have to applaud Samumed for completing a year long phase 3 clinical trial with 675 participants during covid. Other companies such as Cosmo/Cassiopea have been f*****g around for over a decade and they still haven't even started recruiting for phase 3.
 
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jan_miezda

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hairloss is too complicated but i like SM is not targeting DHT but directly trying to restore WNT activity which is more important for HF formation


In this newer study, it proves DHT has a role in even helping HF grwth. the process is so sensitive. but SM drug can help develop more hair without touching DHT. this is for people who think DHT always cause hairloss and if SARD is a solution:

 

trialAcc

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How long have you been in this space bro? Ever seen companies actually deliver on time? I sure have not
This isn't your normal company in the space though. Most of the "cutting edge" stuff in recent decades have been smaller companies/start ups trying to get a single compound to market and failing to deliver on even pre-clinical studies, nevermind getting compounds into the higher phases of human trials. SM has already done all that, and has phase 3 completed, with 48 months of data to present. Just think of the significance of that compared to CB, where Casseopia plans to do a half-assed phase 3 trial that lasts 6 months when there are big questions of their drug past the 6 month mark. If the data is good they will be driving this thing to market pretty quickly.

Samumed has a 12 billion dollar valuation and a massive pipeline in regenerative medicine. Cancers, Arthritis, Alzheimers, solid tumors, pulmonary fibrosis, etc. They are not a lightweight and have the capital to actually get drugs to market.
 

trialAcc

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Not sure why everyones so hyped about this, the phase 2 results weren't impressive at all. They continued to lose ground on vellus/non-vellus hair count up to the end of dosing. After cessation it then normalized to baseline. If anything it will be a good adjunctive treatment.

Anyone thinking this alone is going to regrow their hairline is delusional. Without a 5ar inhibitor you'd just be pissing in the wind.

I hope I'm wrong and they present actual images in march, but I don't think that will be the case.

I'm still waiting to here about exicure tbh. Been hyped for them since I saw their platform and the allergen investment.
What the hell are you talking about? How many hair treatments have results in under 90 days? Even the best treatments we have to date take 1+ year to evaluate full results.

Wait for the results, because you like everyone else here have no idea what to expect based on the early data that was largely used to establish a safety profile. All the phase 2 results showed was that it's safe and that it works in some capacity using an entirely different mechanism then the current market drugs. The extent to which, we will find out. For all we know we're about to get a new wonder drug, or at least a viable safe alternative to minoxodil that actually works for the majority of users.
 
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