Samumed Sm04554 Results Normalized To Baseline

[charlie76761]

which is ?

https://aobious.com/aobious/activators/13044-sm04554.html

 

[resu]

Who knows. It showed regrowth but the study length has been too short to make a definitive statement if results are sustainable. Better than CB & Seti combined probably. We have more success stories on microneedling and minoxidil and Duta/Fina than anything else this year so we shouldn't get distracted by other propaganda.

Seti was a bust last time I looked at it some years ago.

 

[John Difool]

Seti at 2g oral a day didn't bring any results

 

[John Difool]

"Clinicians have 'reason for optimism' in novel osteoarthritis therapies" https://www.healio.com/news/rheumat...or-optimism-in-novel-osteoarthritis-therapies

samumed appears to be delivering promising data on osteoarthritis. I still think their phase 3 study will surprise many in a positive way

The article just says this: "
Lorecivivint (Samumed), a Wnt pathway inhibitor, has moved into phase 3 trials after phase 1 studies showed reduced pain compared with placebo and phase 2 demonstrated improvements in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function.

“We will know pretty soon its efficacy based on signs and symptoms,” Lane said. “We hope the sponsor will look at structure modification.”

which IMHO doesn't provide any promising data, just vague promises without any new data

 

[MrJolly26]

That´s our only option right now, so let´s pray this would work!

I´m positive because that´s the only way we have.

We will see in December/January, maybe this will be shirt again but we have nothing to lose by waiting (it´s different than believing, and we have seen a few Brotzus around so, no, just waiting and nothing else, folks).

 

[John Difool]

First this is definitely not the only option. Not sure what makes you say that. Second we have everything to lose waiting including our hair. I am sorry but if you feel it's a good idea to keep refreshing this page till an announcement is made you are not only using your hair but your time as well. The best option is to try a combination of all the options you can afford trying now! When this thing comes out based on results you can decide to add it to your regimen. There is no silver bullet.

 

[tomJ]

First this is definitely not the only option. Not sure what makes you say that. Second we have everything to lose waiting including our hair. I am sorry but if you feel it's a good idea to keep refreshing this page till an announcement is made you are not only using your hair but your time as well. The best option is to try a combination of all the options you can afford trying now! When this thing comes out based on results you can decide to add it to your regimen. There is no silver bullet.

So is no one getting results on SM??

 

[hypetraintime]

The phase 3 trial has ended - or is close to ending. Here is the trial. They updated it to no longer recruiting on Dec 27 2019 and it follows subjects for 52 weeks. It also mentions the study concludes Jan 2021 (I would guess early Jan). If their other result announcements (for their other drugs) are to go by, they release results 30 - 60 days after completion.

Hopeful Prediction:
I think it will be successful. I don't know how much hair it will grow back when used alone, but in combination with existing therapies, it will work really, really well. I think the 2022 stack will be finasteride, Min, Microneedling and SM for 2 years, then SM only to maintain and keep all the gains made (even with min).

Realistic Prediction:
5 more years boys

 

[nick123]

The phase 3 trial has ended - or is close to ending. Here is the trial. They updated it to no longer recruiting on Dec 27 2019 and it follows subjects for 52 weeks. It also mentions the study concludes Jan 2021 (I would guess early Jan). If their other result announcements (for their other drugs) are to go by, they release results 30 - 60 days after completion.

Hopeful Prediction:
I think it will be successful. I don't know how much hair it will grow back when used alone, but in combination with existing therapies, it will work really, really well. I think the 2022 stack will be finasteride, Min, Microneedling and SM for 2 years, then SM only to maintain and keep all the gains made (even with min).

Realistic Prediction:
5 more years boys

What's this theory that SM04554 will be able to maintain minoxidil gains?

 

[hypetraintime]

What's this theory that SM04554 will be able to maintain minoxidil gains?

If you go deep into Samumed's history and watch their presentations, they aren't some random company making some random drugs. They have stumbled upon a method that allows them to create a platform, not just one hit wonder drugs like Clascoterone (one drug they rub everywhere for different effects). They are able to slightly modify their approach and tackle many degenerative diseases with their secret sauce.

If you dive deep into their history, you can see that Samumed was a spin off from Wintherix & Epitherix (founded by some pretty notable researchers) (pre 2008) which was a startup backed by Pfizer. The relationship eventually turned sour. The technology was at the centre of a battle for rights between Pfizer and Wintherix where Pfizer eventually settled in 2012 and gave over the IP. This was then spun into Samumed who didn't even start advertising a research pipeline until 2016, nearly 10 years after the beginning. From basically nothing to 2018, where they were listed as one of the most valuable companies you have never heard of, around 12 billion. They know something and have made it a point to only let the results of their clinical trials do all the talking (which take time).

A lot of people subscribe to the idea that DRUG -> INDUCE GROWTH or MORE DRUG (higher %) -> INDUCE MORE GROWTH. This works for something like minoxidil, but it's not what Samumed is trying to do. Knowing what I know about Samumed's history and how they are trying to selectively target pathways to restore original function (inhibit or activate), not augment (chemically like finasteride), I subscribed to DRUG -> RESTORES FOLLICLE FUNCTION -> INDUCE GROWTH (like a normal head). An equivalent idea would be something like a pacemaker, which is basically used to help regulate abnormal heart rhythms back to normal. It fixes the problem and lets the heart operate like normal. So basically, fix the follicle, then let the body take over and do what it does best, grow hair.

When they released their phase 2 results, everyone was mad that a higher concentration produced less results with only moderate hair growth in the lower concentration group. Again, knowing what I think Samumed is trying to achieve (restore function), most people seemed to miss the most important detail.. that hair continued to grow after the drug was stopped. This could indicate that the follicles were actually repairing (big news). I believe Samumed was trying to find the exact concentration which activates the wnt pathway just enough to restore follicle function for Androgenetic alopecia suffers, not directly grow hair. Once the follicle is working again, the hair will follow. But, this takes time (almost like a baby growing their hair), It will take a few cycles to mature back to thick terminal.

So my theory is that Samumed believes faulty wnt signalling (inhibited) within the follicle is a main driver of balding and by selectively activating it, they can reinstate the follicles original function. So finasteride and minoxidil will help get back a lot of gains faster, but at a certain point, SM would have healed your follicles to the point that it's equivalent to applying minoxidil or finasteride to someone who isn't balding.. It's doing nothing. Then the continuation of SM would be needed to keep the pathways responsible for regulating the follicle functioning properly.

If you stopped SM, you would begin balding again, but starting from healthy follicles. So it could be years before you even started to notice you were balding again.

Also, aliens are real.

But who knows, we will find out soon enough ¯\_(ツ)_/¯

 

[nick123]

If you go deep into Samumed's history and watch their presentations, they aren't some random company making some random drugs. They have stumbled upon a method that allows them to create a platform, not just one hit wonder drugs like Clascoterone (one drug they rub everywhere for different effects). They are able to slightly modify their approach and tackle many degenerative diseases with their secret sauce.

If you dive deep into their history, you can see that Samumed was a spin off from Wintherix & Epitherix (founded by some pretty notable researchers) (pre 2008) which was a startup backed by Pfizer. The relationship eventually turned sour. The technology was at the centre of a battle for rights between Pfizer and Wintherix where Pfizer eventually settled in 2012 and gave over the IP. This was then spun into Samumed who didn't even start advertising a research pipeline until 2016, nearly 10 years after the beginning. From basically nothing to 2018, where they were listed as one of the most valuable companies you have never heard of, around 12 billion. They know something and have made it a point to only let the results of their clinical trials do all the talking (which take time).

A lot of people subscribe to the idea that DRUG -> INDUCE GROWTH or MORE DRUG (higher %) -> INDUCE MORE GROWTH. This works for something like minoxidil, but it's not what Samumed is trying to do. Knowing what I know about Samumed's history and how they are trying to selectively target pathways to restore original function (inhibit or activate), not augment (chemically like finasteride), I subscribed to DRUG -> RESTORES FOLLICLE FUNCTION -> INDUCE GROWTH (like a normal head). An equivalent idea would be something like a pacemaker, which is basically used to help regulate abnormal heart rhythms back to normal. It fixes the problem and lets the heart operate like normal. So basically, fix the follicle, then let the body take over and do what it does best, grow hair.

When they released their phase 2 results, everyone was mad that a higher concentration produced less results with only moderate hair growth in the lower concentration group. Again, knowing what I think Samumed is trying to achieve (restore function), most people seemed to miss the most important detail.. that hair continued to grow after the drug was stopped. This could indicate that the follicles were actually repairing (big news). I believe Samumed was trying to find the exact concentration which activates the wnt pathway just enough to restore follicle function for Androgenetic alopecia suffers, not directly grow hair. Once the follicle is working again, the hair will follow. But, this takes time (almost like a baby growing their hair), It will take a few cycles to mature back to thick terminal.

So my theory is that Samumed believes faulty wnt signalling (inhibited) within the follicle is a main driver of balding and by selectively activating it, they can reinstate the follicles original function. So finasteride and minoxidil will help get back a lot of gains faster, but at a certain point, SM would have healed your follicles to the point that it's equivalent to applying minoxidil or finasteride to someone who isn't balding.. It's doing nothing. Then the continuation of SM would be needed to keep the pathways responsible for regulating the follicle functioning properly.

If you stopped SM, you would begin balding again, but starting from healthy follicles. So it could be years before you even started to notice you were balding again.

Also, aliens are real.

But who knows, we will find out soon enough ¯\_(ツ)_/¯

Ok I admit it, you got me a lil excited for the phase 3 results.

 

[hypetraintime]

Also for those curious regarding the lawsuits. When Wintherix originally partnered with Pfizer, Pfizer gave them access to its small-molecule libraries for screening. You will have to read more into yourself, but the story goes that traditionally targeting the wnt pathway without the nasty unintended consequences (cancer) was extremely hard. My interpretation is that when Wintherix was given access to Pfizer's small-molecule libraries under their partnership, they were able to sort of 'connect the dots', where everyone had missed them. Hence queue the legal battles where Wintherix won, spun off into Epitherix which then spun into Samumed. Basically the technology that Samumed is founded on today.. being able to develop molecules to target the wnt pathway avoiding the unintended consequences. They have been so quiet so long because they have first movers advantage. Once the secret sauce is out, a lot of companies will be able to follow. And given that clinical trials take years to complete, it can be a very profitable lead.

 

[Tom4362]

One would think though that if they are so confident in their product they would set up an end-of-phase-2 meeting with the FDA ASAP, but they still have not. They are not even sure whether the trial in turkey is enough for FDA approval. But maybe this does not mean anything, idk

Also @pegasus2 knows a lot about the drug and he is pessimistic about it

But then @hypetraintime ‘s post makes me really optimistic (especially the alien part)

conclusion: idk what to think

 

[hypetraintime]

They are not even sure whether the trial in turkey is enough for FDA approval.

I don't know if this trial specifically was ever intended to be enough for a stage 3 FDA. Their 2018 first dose press release says Phase 2/3 and that "the Ministry of Health of Turkey has confirmed that the study, if successful, would support submission of a marketing application for SM04554 in Turkey".

It's probably going to be available in Turkey first, then later in the US after they have the appropriate research to meet FDA requirements.

if they are so confident in their product they would set up an end-of-phase-2 meeting with the FDA ASAP

No idea, maybe nothing or maybe (tin foil hat time) it comes down to strategy and transparency. If they go full FDA release mode, there need to be more disclosures regarding their secret sauce. However, if they can get their hair treatment released in Turkey (and monitor it's performance in the wild) without disclosing secret sauce stuff, they have more time to advance and widen the lead for the rest of their pipeline (Osteoarthritis, Oncology, Alzheimer’s etc) without making too many disclosures.

 

[nick123]

They are not even sure whether the trial in turkey is enough for FDA approval.

Is there a source for this?

According to this: https://www.samumed.com/medium/imag...atment-of-androgenetic-alopecia_503/view.aspx there's a line that states the following "This study is conducted under an IND with the FDA.". Not sure what that actually means for FDA approval though.

 

[hypetraintime]

IND with the FDA is basically just allowing Samumed to ship the drug around for investigation.

In the FDA's own words:
"Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA."

 

[nick123]

Ok and let's say this gets approved in turkey in 2022, do we know if this will be an over the counter drug or would you have to get a prescription from a doctor in turkey?

 

[nick123]

We're talking about Turkey, you will be able to get it, prescription or not. Btw, if we're lucky, this could be approved this year in Turkey already. But of course because of the 'rona, I'd keep expectations low in that regard.

Not really familiar with Turkey to be honest.. I wonder if a bunch of turkish resellers will pop up and ship to other countries.

 

[MrV88]

Not really familiar with Turkey to be honest.. I wonder if a bunch of turkish resellers will pop up and ship to other countries.

I think it won't be some sh*t like Kane that is sold over the counter. Depends on the treatment, probably something you get done in private clinics and/or hair clinics. If it's something you could buy in apothecaries it will be available soon all over or you can at least get your order in 5-48 hours, no need for shady guys that charge you more if Turkey really approves it.

Could take years to get an FDA or EMA approvement, if at all.

 

[John Difool]

I added SM abput a year ago. At 0.15% this is a financial no brainer. I am planning to buy a year batch (that I will test for validity and purity) to renew my stach so if anyone is interested PM me now.