Why would they do this? They are just about done wrapping up their original
phase 2 study and then out of the clear blue they announce a supplemental
phase 2, including biopsies, to find out exactly what is going on under the
surface of the skin. Why would they do this?Why would they invest millions
of dollars into a supplemental phase 2 if they didn’t see positive results
from the original phase 2, which is almost finished?
I can only think of 2 possibilities:
They see positive results from their original phase 2 study so they decided
to do a supplemental phase 2 thinking that they might get enough data from it
that combined with the original phase 2 study and phase 1 study the FDA
might let them put their drug, SM04554, into the marketplace after both phase
2 studies are complete. Keep in mind that the new 21st Century Cures act
allows for “groundbreaking” drugs to come to market after phase 2 trials are
complete if the FDA is agreeable.
They see no positive results from SM04554 and they want to examine below
the skin to find out if SM04554 is having any affect at all below the skin.
But would Samumed use the FDA system to go on a fishing expiation like this
if Samumed saw no new hair growth during the original phase 2 study?
Why would they elect to do another round of phase#2 to speed things up and MAYBE get something out early? They could be putting that time & effort into moving on with phase#3. The FDA is starting to allow occasional rushes to the market before things are finished. That is not the same thing as saying phase#3 is now optional for all.
What’s going on here is the second possibility. Samumed is probably coming up short on results and trying to figure out why.
I acknowledge that it’s possible but why would they do that? I have never
heard of a hair company doing a supplemental study to find out why a phase
2 trial didn’t work. What they typically do after a phase 2 trial fails is
they go away. Some go away fast and some go away slowly but they all simply
go away if they fail phase 2. Either that or they reload the dose or tweak
the drug in some way.
The new act (2oth Century Cures Act) has not been signed into law yet but
it should be approved or disapproved by the end of the year, which is just
a little before Samumed’s supplemental phase 2 would finish.
The way I understand it is that the new law allows drugs to come to market
after phase 2 if the drugs are “groundbreaking.” If Samumed’s drug grows
substantially more hair than minoxidil or finasteride wouldn’t that make it
"groundbreaking?" And if that is the case then wouldn’t the FDA have to have
a good reason to deny approval after phase 2 if the only requirement is
that the drug be “groundbreaking.”
I did not read the actual act (those things are very difficult to read) but
I’ve read 2 or 3 news articles about it and those few news articles
said that the criteria is “groundbreaking” and there’s NO mention that
the drug has to treat a life-threatening or serious condition.
The actual act might say that the condition the drug treats has to be
life-threatening, but those few stories I read about the act aren’t
mentioning that as a criteria so I don’t know for sure. But if the act merely
states that the drug has to be “groundbreaking” then I don’t think the FDA
can reject the drug after it completes phase 2 simply because the drug does
not treat a major physical medical condition.
[quote][postedby]Originally Posted by cal[/postedby]
Why would they elect to do another round of phase#2 to speed things
up and MAYBE get something out early? They could be putting that time &
effort into moving on with phase#3. The FDA is starting to allow occasional
rushes to the market before things are finished. That is not the same thing
as saying phase#3 is now optional for all.
What’s going on here is the second possibility. Samumed is probably
coming up short on results and trying to figure out why.[/quote]
Why would they put time and effort into preparing for phase 3 if they’ve
concluded they shouldn’t have to do a phase 3? Like I said, I’ve only read a
few news articles about the 20th Century Cures Act, and I have not read the
actual act itself, but in the few news reports I read it said that a drug
could go from phase 2 to the drugstore if it’s a “groundbreaking” drug and
the FDA approves it.
Maybe Samumed has concluded with good certainty that SM04554 meets
all of the criteria to be considered a “groundbreaking” drug, and if they have
come to that conclusion isn’t it logical that Samumed might decide to gather
as much data/evidence as possible as fast as they can so they would have the
best possible chance of answering any questions the FDA might have about
the safety and efficacy of the drug? Keep in mind that even if SM04554 meets
the criteria to be a “groundbreaking” drug that doesn’t free Samumed from
also having to prove that the drug is safe and effective. If the act becomes
law it’s my understanding that “groundbreaking” drugs can be marketed after
phase 2 if they meet FDA requirements in terms of safety and efficacy.
Also, keep in mind that there are reasons for Samumed to try to rush
SM04554 to market if it works. iPS cells, hair inductivity research,
3d printed follicles, and all of the other potential treatments are getting
closer and closer to the marketplace every day so Samumed would want to get
SM04554 into the marketplace fast so they can own the entire market for
awhile before their competitors get their treatments to market.
Also, some estimates indicate that phase 3 studies account for 90% of the
expense of bringing a new drug to market. That’s a lot of money. If SM04554
works, wouldn’t Samumed want to avoid the expense of the phase 3 study if
they can?
First I’ll give the key quote in the article and then I’ll post the link to
the article
“The 21st Century Cures Act allows drugs to be rushed to the market, removes phase 3 testing as a requirement for drug approval, bases
drug approval on biomarkers rather than actual health outcomes, and
encourages the production of new antibiotics at a time when
microbiome destruction is increasingly being linked to chronic diseases.”
Cal, keep in mind that the new 21st Century Cures Act allows the FDA to use biomarkers as some of the evidence to determine whether or not to
approve a new drug. keep in mind that Samumed’s extra phase 2 study involves
scalp biopsies. Correct me if I’m wrong, but don’t biopsies
produce biomarkers?
Here’s an article that talks about how the 21st Century Cures Act allows biomarkers to be used in the FDA approval process:
My point is that if biopsies produce biomarkers then the additional phase 2
study that Samumed has just embarked on (out of the clear blue) is the exact
type of study that Samumed would need to do in order to have a chance
of avoiding the phase 3 clinical trial.
Phase #3 has been around all these years for good reasons. There are downsides & risks to skipping it.
Any remotely decent MPB treatment is assured to make its money back. And the researchers & investors aren’t emotionally wrapped up in how quickly it gets released like guys on the MPB forums.
“Skipping phase #3” would be better described as “selling during phase #3” in many cases. In light of this probability, you have to ask yourself what is more likely here.
IMO it’s far more likely they are failing to get results, and this phase #2 extension is a last-ditch attempt to understand why. A failed phase #2 usually means a failed project and no further funding. If they can’t produce hair then they will try to produce an explanation and avoid getting cut off entirely.
[quote][postedby]Originally Posted by cal[/postedby]
Phase #3 has been around all these years for good reasons. There are downsides & risks to skipping it.
Any remotely decent MPB treatment is assured to make its money back. And the researchers & investors aren’t emotionally wrapped up in how quickly it gets released like guys on the MPB forums.
“Skipping phase #3” would be better described as “selling during phase #3” in many cases. In light of this probability, you have to ask yourself what is more likely here.
IMO it’s far more likely they are failing to get results, and this phase #2 extension is a last-ditch attempt to understand why. A failed phase #2 usually means a failed project and no further funding. If they can’t produce hair then they will try to produce an explanation and avoid getting cut off entirely.[/quote]
Phase 3 has been around for a long time but it has outlived its’ usefulness. It was created at a time when drug companies were doing a lot of guessing and hoping when it came to drug discovery. A lot of cures were discovered by accident or near accident. Today, drug discovery is more deliberate and precise. Today the scientists inventing cures for medical conditions are highly skilled and knowledgeable. They know exactly what they’re doing. Plus, today they have other ways of measuring how drugs will act in the body that they did not have back in the days when phase 3 trials were instituted. It’s outlived its’ usefulness. Plus, even with phase 3 studies some drugs get into the marketplace that shouldn’t so does that mean we should have a phase 4, phase 5, phase 6? If you want to eliminate all risk then maybe we should stretch it out to phase 20 but then we’ll all die of diseases and never get cured of anything.
Researchers and investors better be emotionally invested in how soon their hair loss treatments get to market because soon there may be multiple breakthrough treatments available and the more of them there are the more they have to divide market share. I’m certain that each of the researcher groups/investor groups want to get their breakthrough treatment to market first because whoever gets a breakthrough treatment to market first gets to own the total market until the other research groups/investor groups bring their treatments to market. They all want to be first.
Since I have never seen a phase 2 hair research team opt to do an extra phase 2 study to gather biomarkers before moving on to phase 3 it does seem odd to me that this is happening. It also seems odd to me that they’re doing this at a time when a pending act (that’s favored to become law) coincidentally allows drug companies to use biomarkers in lieu of phase 3 studies. I think it looks like Samumed is conducting a biopsy study so they can gather biomarkers to submit to the FDA in lieu of a phase 3 study. Of course it’s possible that SM04554 failed the original phase 2 study and they’re doing biopsies to try to find out why it failed, but I have never seen a hair research group do that before after a phase 2 study. Typically, when a phase 2 hair loss drug fails the research group shuts down and fade away quickly or slowly. Or else they tweak the drug (especially the dose) and start over. I have never before seen a situation where a hair research group failed phase 2 and then initiated a phase 2 biopsy study. And again, keep in mind that this is happening at a time when an act, which is favored to become law, allows drug companies to use biomarkers in lieu of phase 3 studies, and biopsies produce bio-markers.
You make it sound like it’s typical for hair research groups to do biospy studies to find out why their phase 2 drug failed. I’ve never seen it before. You make it sound like (if SM04554 failed phase 2) Samumed NEEDS TO find out why it failed but they don’t NEED to. And you yourself said that if treatment fails phase 2 the funding ends but they’re receiving more funding to do the extra biopsy phase 2 so the funding continues. So are you saying that SM04554 did not fail the initial phase 2 study? And Samumed has other promising drugs in the pipeline so there’s no threat that all of Samumed would be shut down if their hair loss drug fails.
Of course I agree that there’s a chance that SM04554 failed the initial phase 2 and Samumed is doing the biopsy study to find out why their initial phase 2 study failed, but I’m also saying that the greater likelihood is that the drug did not fail and Samumed is making strategic moves to get SM04554 into the marketplace as fast as possible so they can get it into the marketplace ahead of the competition.
Another possible explanation for the biopsy is that Samumed has achieved positive results, but wants to ensure that they fully understand how they got them. This is critical for supporting - and protecting - their ‘patent’ application and exclusivity rights. Also, the FDA application requires that they answer this question (2.3) ‘Do you certify that, as of the date of this declaration, you have test
data demonstrating that a drug product containing the polymorph will perform the same as the drug product described in the NDA? The type of test data required is described at 21 CFR 314.53(b)’.
More broadly, after many years perusing these forums, I believe we will see the first real breakthroughs in hair-loss treatments over the next 2 years., There is a powerful convergence of breakthroughs in our understanding of cell biology (ie signalling, stemm therapies etc), novel compounds, computer processing power, investor interest and the participation of major cosmetic companies like Shiseido.
Follicular, I think that it’s MORE LIKELY that they are doing the extra phase 2 so they can use the bio-markers from the biopsies in lieu of a phase 3 study. Rogaine has been through phase 3 trials at least 3 times (for 2%, 5%, and for women) and both finasteride and dutasteride have been through phase 3 trials once each, and none of these involved an extra phase 2 to do a biopsy study. So it’s not customary to have to do an extra phase 2 for biopsies for hair loss treatments.
Also, if the new 21st Century Cures Act passes they won’t have to do a phase 3 study so why would they? Why would they choose a VERY expensive phase 3 over an inexpensive study that produces the required biomarkers? If you were the CEO of Samumed and you had a choice between using a VERY expensive phase 3 trial or cheap bio-markers which would you do? Keep in mind that some estimates indicate that phase 3 trials account for as much as 90% of drug development costs. Why would they spend all of that money if they don’t have to?
Also, if their drug, SM04554, is a breakthrough then why would they want to take any longer to get it to market then they need to? Keep in mind that the longer they delay getting it to market the more their competitors catch up with them. Right now they are ahead of their competitors because they are just wrapping up their initial phase 2 study. No other credible drug is this far along. Even iPS cells are not in human studies yet, but Shishiddo should be putting them into human trials very VERY soon. Shisheido says they’ll bring them to market by 2018. If SM04554 works it’s in Samumed’s interests to get SM04554 to the marketplace asap so they can sell it for as long as possible without having to share the market with competitors.
With all of the above in mind why would they want to do a phase 3 study if they are allowed to do a cheap study that gathers bio-markers in lieu of the phase 3 study? Here is an article showing they can use biomarkers in lieu of a phase 3 study if the 21st Century Cures Act is passed:
[quote][postedby]Originally Posted by cal[/postedby]
Why would they elect to do another round of phase#2 to speed things
up and MAYBE get something out early? They could be putting that time &
effort into moving on with phase#3. The FDA is starting to allow occasional
rushes to the market before things are finished. That is not the same
thing as saying phase#3 is now optional for all.
What’s going on here is the second possibility. Samumed is probably coming
up short on results and trying to figure out why.[/quote]
I think the FDA had to give an OK for this additional phase 2 study to take
place. Would the FDA allow a drug company to do a fishing expedition type of
experiment on a human being just to find out why a medicine did not perform
well in clinical trials? It seems like they would not. Keep in mind that all
of these clinical trials have risks to the test subjects and I don’t think
the FDA would allow a drug company to take risks with human test subjects
if it’s already established with certainty that the drug does not work.
I don’t think the FDA would let a company put humans at risk just to find
out why their drug did not work.
[quote][postedby]Originally Posted by Follicular[/postedby]
Another possible explanation for the biopsy is that Samumed has
achieved positive results, but wants to ensure that they fully understand
how they got them. This is critical for supporting - and protecting - their
’patent’ application and exclusivity rights. Also, the FDA application requires that they answer this question (2.3) ‘Do you certify that, as of the date of this declaration, you have test
data demonstrating that a drug product containing the polymorph will perform
the same as the drug product described in the NDA? The type of test data
required is described at 21 CFR 314.53(b)’.
More broadly, after many years perusing these forums, I believe we will
see the first real breakthroughs in hair-loss treatments over the next 2
years., There is a powerful convergence of breakthroughs in our understanding
of cell biology (ie signalling, stemm therapies etc), novel compounds,
computer processing power, investor interest and the participation of major
cosmetic companies like Shiseido.[/quote]
In order for a drug company to do any human study, including the extra phase
2 study that we’re talking about, the FDA has to give the company permission
to conduct the experiment. All of these studies have some risk, including the
extra phase 2 study that we’re talking about. Would the FDA allow a drug
company to put human beings at risk just so a drug company could protect
its’ patent rights?
But then again, I doubt if the FDA would allow a human study (putting
humans at risk) that would satisfy the requirements of a pending legal bill
that is not yet law.
Jarjarbinx, yes, the FDA approval and patent are separate issues. I tend to agree with you that the company may be trying to expedite the launch of its product. I certainly hope this is the case.
Roger is probably the poster with the most knowledge about biology so I’m curious what he thinks about this discussion. For example, I do not know for sure that biopsies produce bio-markers, and I base my entire idea that Samumed is planning to ask the FDA for approval after phase 2 on the notion that biopsies produce bio-markers, so it would be interesting if he would chime in and comment on my idea that Samumed is probably planning to ask for approval after phase 2.
I haven’t been following Samumed, but I can say that if it doesn’t involve putting some kind of live cultured cells into the scalp, I’m not that hopeful that it could be anything close to the cure we’re looking for.
Yea I know you believe that, but why do you think Samumed is doing the extra
phase 2 study? I think they’re doing it because the new pending 21st Century
Cures Act allows for drug companies to use bio-markers in lieu of phase 3
studies. Samumed’s extra phase 2 study involves biopsies so I think that
Samumed is planning ahead to this bill passing and they’re doing the extra
phase 2 in order to gather bio-markers so they can use those bio-markers in
lieu of a phase 3 study if the act becomes law.
The history of HM includes multiple cases of phase#1 and #2 trials done on stuff that never did produce anything worth selling and they should have known better. It doesn’t require stupidity, it just requires researchers who are spending other people’s money and therefore have very little to lose. You can call this illogical but it still happens regularly.
I think Samumed’s WNT approach does not sound like it has much chance of a success. As Roger has been pointing out, probably nothing short of cellular work will make the kind of cosmetic MPB reversal we want.
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