Samumed SM04554 Trial In Turkey
SM04554, a Wnt activator from Samumed, is currently the only new drug worldwide at a phase 3 trial for androgenic alopecia.
Samumed Pipeline
Last month, Samumed’s CEO Osman Kibar was featured in a Fierce Biotech article which covered Samumed’s various programs for oncology, arthritis, and of course – alopecia. At the end of the article there was a brief mention of an anticipated approval timeline of late 2021 for SM04554, but was not specific about which territory this would be in, as we know the trial is taking place outside the US.Coincidentally, a few weeks before the article was published, I had reached out to a Patient Advocacy Associate at Samumed who helps keep patient groups updated on treatment progress. On a side note, it’s an honorable deed for Samumed to have such a person on staff at this time. I received this response from the Samumed associate regarding the current trial for SM04554 and its implications for approval:
“Thank you for your question regarding SM04554 and the phase 2/3 trial being conducted in Turkey. Based on our pre-trial meeting with the Ministry of Health in Turkey, if the trial meets its primary endpoints, the data would support a marketing application in Turkey. Further, the trial also supports our IND with the FDA. We have not yet had an end-of-phase 2 meeting with the FDA. Based on the data from the trial, we would determine whether to have such a meeting to discuss with the agency what further data and trials would be necessary to support an NDA here in the United States.”
For clarity, the current trial in Turkey could allow approval in Turkey only, while also supporting the data package for US FDA approval. As stated clearly above, there is potential that a further trial may be necessary to reach the US market. While this news may not be considered optimal for US residents anticipating SM04554, it’s certainly better to find out now than in 2021. Based on previous trials for SM04554, safety should be a nonissue. We certainly hope the efficacy results support the drug to get to the US in the shortest amount of time. One interesting note to end upon is the current phase 3 trial is testing two different concentrations of SM04554, 0.15% and 0.25%. With such a large number of subjects in this trial (625), identifying the optimal treatment dose will be obvious and support the best version of SM04554 for market release.
Posted in Hair Growth Treatment, Samumed
Hey,
Do you know if anything of substance besides NGF 574 is releasing this year or maybe 2020 – Q1?
Thanks.
The only potential at this time would be an unexpected RCH-01 release, or another cosmetic topical coming out. Possible, but seems like a longshot for now.
check their Fb page!
Samumed has surely a promissing approach, but I am still sceptical concerning a possible longterm cancer risk of the Samumed approach.
As we have known for a long time the WNT-pathway is a main driver of cancer (a recent study can e.g. be found at https://www.ncbi.nlm.nih.gov/pubmed/28647886 ).
According to a recent Fierce Biotech article “Samumed’s drugs target CLK and DYRK, kinase enzymes that are upstream of the Wnt pathway” ( https://www.fiercebiotech.com/biotech/conversation-osman-kibar-ceo-samumed ). So they want to minimize the obvious WNT pathway-cancer risk.
But also CLK is involved in cancer development, so CLK-inhibitors are a promissing anti-cancer strategy (a recent study can be found at https://www.ncbi.nlm.nih.gov/pubmed/29769258 ). The same is true for DYRK: https://www.ncbi.nlm.nih.gov/pubmed/28554575
So in my opinion it is still unclear, if Samumed´s approach is safe enough in the long term to get an approval. I am looking forward to the phase 3 safety results.
Best regards
Andreas
I’m surprised that this company is still moving forward with this treatment. The reason being one of its trials showed that the treatment was not dose dependant. Usually when higher doses don’t increase the result the product gets ditched. Therefore, you can only assume they have improved the proposed treatment. This company and treatment has never resonated with me for what ever reason but if they have resolved any issues could be a good one to look out for with a decent time frame. Plus Turkey has a good reputation in the hair industry through several very good hair transplant clinics. Fingers crossed.
I think they did the trial in Turkey cuz it was more cost efficient for them, that way they get to see if the drug performs in a phase 3 and not risk the money it costs in US. But if it does work do they have to do another phase 3 in America?
This is a good question, if things go well in Turkey I can’t imagine they would need to do another 600-person trial. Maybe just another phase 2 size trial but for a longer time period.
Aclaris now froze and samumed is maybe longer than we thought to get in US market. Cell therapies looking better everyday.
The fact the Aclaris news came out right around the time I received this message from Samumed led me to hold off from posting it immediately, needed some good news to balance things out like J.Hewitt etc.
One positive spin from this though is Follica should certainly be out in the US market before SM04554 is. The wounding technique that Follica uses theoretically couples well with stimulating the Wnt pathway like SM04554 does, so when SM does get to market it could give a nice enhancement to the Follica results. Hoping that Follica may share more details from their ongoing safety and optimization study by the end of the year. That would be well appreciated by everyone I feel.
So this will be available in Turkey in 2020 if it’s efficient enough?
No, it seems that the earliest it would be available is 2021 in Turkey.
When is Follicum’s next trial for aga? Arent they close to phase 3?
Follicum has a phase 2b to complete which should be enrolling by the end of the year. There may be an announcement from the company within the next month or so about a the phase 2b trial featuring the new topical formulation.
Phase 3 will end in 9 months. Market release in 2 or 3 years… Disappointed.
FT,
What is your opinion on this treatment?
Reason I’m asking is because based on the number of comments there doesn’t seem to be much interest here. It’s an American company (clearly most of your audience live in America) and it is a phase 3 trial. Am I missing something?
Cheers
Welsh, I think it has to do with the fact that there is a potential delay in waiting for a US release when this trial is completed in Turkey. It’s efficacy results in previous clinical trials were modest, but after only a 3 month period of using the product. I think if this were coming to market next February everyone would be pretty excited about it, but the 2-3 year wait is a bit of a “weight.” People want results now. This is one of the reasons I was always in favor of seeing what HairClone could do. Every treatment is a coin flip but if the coin lands the right way it’s a big benefit to us all.
Anyways, as far as potentially more imminent solutions one of my next articles will be on the WAY-316606 development. 🙂
Thanks for the response FT. Yeah makes sense.
Look forward to the WAY news.
Cheers
Can I regrow receding hairline this medicine please reply
There is some hope for sm04554 but the fact it will go to Turkey first is a little bit of a damper. It kinda sounds possible that fda may accept the data in US, we’ll have to see.
Samumed treatment have a big advantage over Min&Fin : that is no sides effects. As for the efficacy, it’s on par with them, maybe slightly better.
Maybe on par with min but i don’t think it’ll be similar to fin. Would be amazing if it was but i dont think it will.
Yes I as well look forward to the WAY news, when is this published please?
The WAY clinical update will definitely be published before the end of the month. Most likely next week.
Hi Admin, what do you think about Histogen development?
Wasnt HSC in Phase 3 already?
Now Pipeline Shows HSC (now called HST 001) in Phase 1b.
But interestingly a product called CCM Cosmetics shows as “Marketed” with Allergan and Hydrafacial. What is this Cosmetic for Hair Growth? Where and when can I get it?
“soluble multipotent cell conditioned media (CCM) that is the starting material for products for hair growth, skin care and other applications”
http://www.histogen.com/technology/#development-pipeline
I’d have to be honest and say it’s slightly disappointing that Histogen is back to a 1b trial for HSC. As of now it is not clear whether this is the old HSC or the new HSC 660 version, or whether this is indicated for men or women. Lots of variables and changes seem to go on for Histogen quite often. I still like the product, still think it would be a great benefit to almost everyone. The US timeline of approval is now somewhere around 2024.
The CCM product is used for cosmetic skincare products such as Regenica. For now they do not have an over the counter hair growth product but it would be a good idea and they should probably pursue it. Many people would be interested in an HSC-like product but used topically. Perhaps finances are an issue, if not it would seem logical to try a topical HSC.
my hair loss is now become visible.
how can I hide it?
Hi Jengo, as far as hiding it one of the best options used by many people are hair loss concealers. These are essential a fiber powder that you sprinkle into your hair which thickens the appearance of your hair and covers up thinning spots. There are several brands, right on the sidebar of the site is an advertiser link for Instant Hair which is a good quality hair concealer.
yeah histogen news leaves more questions. If only they would try a topical hsc would be nice. Imagine if it worked it would be a great consolation for all of the delays.
Hi Admin, thanks for your Answer on Histogen issue. It seems to me that Histogen is now Supplier to Allergan for the CCM Product for Cosmetics. Could you maybe get in contact with Allergan to check what Cosmetic Hair Growth Products they plan in the near future. Allergan seems to get an important Player in Hair Growth Industry with several Drugs and Partners. Also the Hair growth Cosmetics and Stem Cell products get serious now (see Medipost and others). These can be released much quicker than Drugs with the long Trials.
I’ll see if there if it is possible to get some words on a potential Allergan/Histogen hair growth cosmetic product. I think you’re right that Allergan especially should pursue this they have virtually unlimited funds and a product for hair would be much more popular than skin. Maybe it’s still too early for them we’ll see.
Thats great, thank you! If you get in contact with a nice Person who is willing to update you on Allergan plans please ask for all the Allergan Pipelines:
Histogen Cosmetics (no Trials needed)
Allergan Kythera KYTH-105 Setipiprant (finished Phase 2)
Bimatoprost (approved and finished Phase 2 on AGA)
Pelage RCDG423 and UK5099 (starts Trails soon I guess)
Botox against AGA (approved and in Trails on AGA)
None of these show in the current Pipeline even they are in clinical trails. I get the Feeling Allergan is hiding something and plans to come out with a big bang soon. I can not remember a Company involved so much and widely in AGA Research)
A great read on hair loss click below
https://www.google.com.au/amp/s/amp.theguardian.com/lifeandstyle/2019/sep/07/new-hair-loss-research-balding-medical-treatments
It’s too late for a topical hsc. It would need to remake all the trials from the start and would delay market approval by 10 years. I’m planning to go to Mexico in 2020 or 2021 for the treatment.
@Jonathan where in Mexico is allowing Histogen in 2020 or 2021? how did you find out about this??
Phase 3 end in june 2020. They said they anticipated success so they are also working on commercialisation. I don’t know where in Mexico but we will know the details when phase 3 will end.
I thought Histogen’s partner in Mexico took a dump. This was my plan too but I think it’s dead in the water, Admin will know, I believe this was in an update he posted.
Yes didn’t the recent article on this site confirm that the phase 3 Mexico trial had fallen through?
Yes, the last I’ve heard from Histogen (Gail) the Mexico trial was cancelled because the potential partner was no longer going to pursue the trial.
Talking of Allergan … Botox against Hair Loss News:
Phase 2b Trial botulinum toxin Nabota for the treatment of hair loss.
https://www.trialsitenews.com/dangook-university-hospital-center-of-hair-loss-treatment-clinical-trial/
http://www.daewoong.com/content/content.asp?FolderName=sub02&filename=sub02_0601
dear all,
how you consider these figures for NGF-574H?
https://www.dropbox.com/s/onwlx4xgvjcspzd/574H%20clinical%20trial%2016wk%20%28Eng%29%20v2.pdf?dl=0&fbclid=IwAR1mxn0YCmpD_G9h5OnEZjI1wO9T13gI_SQr0SnR2Y2njW06137sNTLxKG8
They look good, problem is;
Weren’t nearly all the subjects women?
I like it that Samumed is pushing hard but I don’t like it that their previous studies showed mediocre hair growth.