Samumed’s Moving Into Phase 3
It looks like we may have another approved treatment on the market within the next 2 years.
Today, Samumed released a newsletter addressing its program for androgenic alopecia, and stated that the company “has conducted an Investigator Meeting to initiate our upcoming 625-patient Phase 3 clinical trial.”
While the results from the phase 2 trial of SM04454 (Samumed’s drug for AGA) were not jaw-dropping, it can only be a positive occurrence for a hair growth drug to make it to phase 3 in 2018. If approved, SM04454 would provide a new treatment option for many people and also may “stack” well in current hair growth regimens. This means it may provide synergistic benefits when used in conjunction with other treatments such as minoxidil, finasteride, PRP, etc. SM04554’s safety is almost a sure thing at this point, it just needs to show enough efficacy in the phase 3 to move forward.
Posted in Samumed
If follica hits phase 3 you can bet people will use this with follica to get better results.
Follica already has patents out for SM used in conjunction with their rain product.
Great news! I wasn’t even 30 yet when the last treatment went into phase 3. Hopefully this will make it to market before I hit 60! Joseph, when you say results weren’t “jaw dropping” didn’t they only report results for 60 or 90 days after the phase 2 trial ended? Possibly the results got better with time/hair cycle growth and/or phase 3 will allow them to optimize the treatment protocol?
I am hoping that results will continue to improve over longer durations, such as a year or so.
1) I remembered that they said they will conduct another phase 2, has it been done or did they cancel it ? If they have done a third phase 2, has the results been published ?
2) Did they mention how long will phase 3 last ?
3) Per FDA regulation, phase 3 must consist of 1000+ patient, they only have 600+ patients, is it legit ?
Many thks
As far as I can tell they skipped the extra phase 2. Do you think they are implementing a phase 3 that will be a waste of their time and money? Enjoy the news brother, enjoy. Peace.
I believe they had an extension to Phase 2 where they did scalp biopsies…maybe a 2B. In regards to Samumed wasting money, I’m from San Diego where they are based and are thought of as a respected, shrewd company. This is also true of Gail Naughton of Histogen, another local company. Does this guarantee success, no. But these people aren’t idiots nor trying to concoct snake oil. Too many ridiculous “theories” on internet hair loss sites! People need to save it for the real snake oil out there, not respected biotech’s that may or may not succeed.
Phase 3 study participants range from 300 – 3,000
Source: https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm
Thanks Ahmed 🙂
Just FYI everyone, that when sharing this news on other sites I appreciate it when you cite this article as your source of finding the news.
Is it able to maintain hair?
How long does Phase 3 last ?
What are the next steps in a best case scenario and reasonable timelines to be expected?
thx
Thanks for reading Follicle Thought. Phase 3 is around 1 yr. If all goes well they submit NDA to FDA and we could realistically imagine drug approval late 2020.
Phase 3 is 1 to 4 years. Lets see what Samumed is aiming to do. Hopefully they would do it real quick.
@admin: they mentioned 625 patients, does it mean that they have already finished recruiting ? Or is it just the minimum number that they have agreed with FDA ?
I’m disgusting and i don’t think any of this is going to help me… At least not while I’m young enough for it to do me any good.
My youth is gone and I can’t take it anymore
Hair loss doesn’t take away the qualities that make you who you are, man. It may be a distraction. It will get better if you accept it for what it is, then it can’t be bigger than you. That doesn’t mean you won’t take action to change it one day, when you can.
Until then, think about getting a buzz cut or keep your current look. Enjoy your life, when the hair does come and you look back, how would you wish you lived these years?
Is this stuff like a growth stimulant only ? I am asking because if it is just a growth stimulant like minoxidil, then we will lose the battle eventually since DHT is still there and kill our sensitive follicles