Histogen Phase 1B/2A Trials for HST 001

Update: December 1, 2020 — Histogen just announced preliminary week 18 results for its HST-001 Phase 1b/2a clinical trials.

  • Good news: Patients treated with HST-001 grew new hairs in the vertex region of the scalp.
  • Bad news: HST-001 did not achieve statistical significance at the week 18 primary endpoint assessment.

Note that the trial is not over yet. We now await week 26 results in two months time.

Update: October 5, 2020 — Histogen completes final dosing in its 1b/2a trial for androgenic alopecia in men.

Update: June 23, 2020 — New update on Histogen study from Emily (see bottom half of this post for more):

“As of this morning, we are half way enrolled. The last day to screen for the study will be July 10th. If anyone is interested, they should call me this week and I will get them scheduled.”


June 16, 2020

Histogen History

I first covered San Diego based Histogen (stock ticker HSTO) in 2014. At the time, there was a lot excitement about the company’s Hair Stimulating Complex (HSC) product HST 001. It is supposed to be more effective than Finasteride or Minoxidil in treating male pattern baldness. Histogen’s Linkedin page currently shows them with 28 employees and 584 followers.

This HST 001 product is an injectable that contains key growth factors which benefit hair growth. These include KGF, VEGF, and follistatin, all of which positively impact hair follicle stem cell proliferation. The growth factors are produced by hypoxia-induced conditions.

Failure

Between 2014 and 2018, Histogen made steady progress. In 2018, when I last wrote about the company, they were set to start Phase 3 clinical trials in Mexico. The excitement in the hair loss world was palpable. Histogen was also starting trials for its women’s hair loss product HSC660.

Most people assumed that Histogen’s HSC would be available by 2020. Unfortunately, something went wrong and the company never managed to complete those final Phase 3 trails.

Histogen Hair Stimulating Complex Round Two

Instead, in 2019, Histogen went “back to the future” on us. They announced that they were starting Phase 1b trials! This major regression on the part of Histogen was shocking. And when combined with the demise of Aclaris Therapeutics’ JAK inhibitor trials for androgenetic alopecia, 2019 ended up being disappointing. The one positive was that at least Histogen did not disband or go bankrupt.

Histogen HST 001
Histogen Hair Stimulating Complex (HST 001) Trials.

However, Histogen is now back on track again and has received FDA approval to proceed with trials in 2020. Moreover, the company merged with Conatus Pharmaceuticals in 2019 and made Richard Pascoe the new CEO.

Histogen CEO  Richard Pascoe’s 2019 Presentation

Dr. Pascoe made the following interesting presentation in 2019:

I was still not planning to write any post covering the company this year. My goal was to only write about Histogen again if they announced completion of Phase 2 trials. I did not want to go on yet another wild goose chase.

However, I was forced to alter my decision because of the below e-mail that I received out of the blue today. I am surprised that they mention Histogen in the e-mail and do not keep the company name private.

Patient Recruitment for HST 001

Hello Page Admin of Hair Loss Cure 2020,

I am the Manager of Recruitment at California Dermatology and Clinical Research Institute. We are a research site in Encinitas, California focused on dermatology specific clinical research studies.

We just opened enrollment for a male pattern hair loss study testing a new investigational treatment. The sponsor is the San Diego based drug manufacturer, Histogen. Here is a bit more information on the development of this drug so far: June 1 Announcement.

We are looking for participants ages 25 – 55 who are grades 3 vertex, 4 or 5 on the Norwood Hamilton scale and are not currently using finasteride or minoxidil. This study will take place over a 26 week period and has 7 visits to our office in Encinitas. Compensation may be provided to those who qualify and enroll.

If you think any of your viewers would be interested in participating, I would really appreciate you sharing our information!

Anyone who would like to see if they may qualify can reach me at (760) 203-3836. If anyone is interested, they should contact me at their earliest convenience, as the study hopes to fill enrollment within the next month.

Emily Baker
Manager of Recruitment and Digital Presence
California Dermatology & Clinical Research Institute
561 Saxony Place Suite 102, Encinitas, CA 92024
P (760) 203-3839 x102 | F (760) 203-3840 |
www.cdcrinstitute.com

It is encouraging that they are testing HST 001 on men with extensive baldness only.

Please contact this company only if you satisfy all the requirements mentioned in the e-mail. You have to travel to Encinitas (San Diego), California seven times in six months. So I am guessing that you do not want to contact them if you do not live nearby.

Dr. Gail Naughton Presentation

Histogen CEO Dr. Gail Naughton’s 2013 presentation can be seen here. In there, it is mentioned that the company’s Hair Stimulating Complex was already in Phase 2 trials :-( Dr. Naughton seems to have a stellar reputation in the biotech and regenerative medicine world. Update: Also see Dr. Steven Chang’s 2018 presentation.

75 thoughts on “Histogen Phase 1B/2A Trials for HST 001”

  1. If they would have done everything right businesswise, Histogen would be on the market already…

    Anyhow, watching the video of Naughton in 2013 (!) they really had some promising results already. The research goes back as far as 2008.

    It‘s good to know that this therapy is safe and effective and proofed to be working. So this time I am very confident that it’s really just a question of when, not if.

    A future combination of Hairclone and Histogen could be something close to a cure and is not that far away.

    1. I’m new here, but by soon do we mean 7 years or more. It seems getting all the way through medical trials can take more than a decade.

      1. I don’t know about Histogen and the exact requirements for their product to go commercial, especially which category of medical treatment they fall into in terms of trials. 7 years seems long to me, but I would assume they need minimum 1 year for each trial stage: recruitment, treatment, data read-out, authority approval. 4 years is definitely realistic.

        Hairclone on the other hand starts next year with a provisional approval.

        1. My friend, 5 minutes of google will tell you that the average time for 3 phases of trials by the fda takes 7 years. Plus on average 1,5 years for the fda to approve.

          I m not sure what phase 1b/2a means. If they can go directly to phase 3 afterwoards that would mean they are roughly 6,5 years away from beeing available.

          Your 4 years are way to optimistic. Raising false hope doesn t help anyone

    2. I live in Oregon. Will they reimburse for travel? Is this same as Histogen’s past Phase 2 trial method for hair loss?

  2. I’m only a NW 3 or else I’d give them a call. I wouldn’t mind driving 1.5 hours to get the treatment. It’s very encouraging that they want very advanced balding men. I wonder if this treatment will work on the temple region.

  3. Sometimes I see drugged and alcoholic bums on the street with their heads full of hair, the old Chet Baker looking type … I don’t do drugs ” apart from finasteride ” and I also drink very little, but I am BALD :( the mysteries of life I guess… I wanted to write a long and depressive post, but what’s the use? … good night people

    1. I feel you man. I feel the same way. Just gotta stay optimistic with future treatments and possible “cures”.

    2. Go to turkey to get a hair transplant bro.

      I went 4 years ago and even if you dont gent the perfect density (which is normal with just 1 hair transplant), neither the perfect job (they populated my left less than the right one)

      After 4 years and 2 years without taking finasteride my hair is looking a bit patchy. I knew that would happen without finas, but thats poison for me. The solution? I’ll go for another hair transplant probably next summer, letting more native top hair falling out, thing that is even better for a hair transplant.

      Don’t find excuses like oh im embarassed or oh i dont trust them or oh i have seen bad results on internet.

      The only excuse is if you dont have a great donor area. Otherwise go for it.

  4. I’m so afraid to get my next haircut. Dut and RU not working anymore and my hair is so long and looks terrible because I can’t bring myself to cut it and see how bad it is.
    Like a bad nightmare, really we still don’t have anything to help us?

    1. D1, Because the results suck. Before and after no differents. Only a sucker would spend money on this. If it doesn’t regrow a full head of hair or has little potential then I’m not interested. Basically snake oil. These scientists are literally waisting our time. Except for tsuji

  5. I live in San Diego, have extensive hairloss, and have never used any hairloss drugs. I’ll definitely consider signing up! Though, I am hesitant to use something experimental on my body.

    1. I am curious how these trials differ from the older Histogen Phase 1 and Phase 2 trials from a few years ago. If you call this clinic Daniel, please let us know more details!

  6. Hello Admin,

    I hope that you and your loved ones are safe and sound during this very weird and uncertain time. I’ve been reading your blog for quite some time, and I definitely appreciate the hope and perspective you bring to the table. I have a sincere question: given that it is already 2020, and we have made little progress, if any, in the quest to find a cure, do you sincerely believe that we are still on the cusp of finding and being able to use a cure? Do you feel that COVID-19 will further complicate the race for a cure? Thanks! :)

  7. Yeah the company who was gonna run the phase 3′ s in mexico copped out on them. Sucks.

    The accelerated pathway was for approval in mexico. Since histogen is going back to a US based pathway, so you can expect a significant rollback in the development pipeline. Also there was a replacement of the bovine albumin with human albumin and that could of pushed things back even more.

    What is nice is that histogen is in a very good place right now fiscally. Most biotechs would of died with the lawsuits. Histogen has the allergan deal and public investment. If all goes well we could see a few years of steady progress in trials which would be just ducky. All we can do is hope I guess.

  8. Looks like the data for the hst-001 trial is expected in Q4 of this year. Bet it gets delayed a few months because that is who things work, but it is nice that the trial seems to be short since histogen takes effect over a 90 dayish period.

    Top-line Data HST 001 Phase 1b/2a Trial – Q4
    Source: https://investors.histogen.com/static-files/ff402769-83eb-46fc-a3bb-b340cdc76f6c

    Location of the link to the pdf: https://investors.histogen.com/news-releases/news-release-details/histogen-present-bio-digital-2020

    Looks like this presentation will only be hosted for 30 days.

  9. In this magazine we can get the actual Tsuji-Update (January 2020). The full article can be bought on amazon:

    https://www.amazon.co.jp/o/ASIN/B081WVBKV5/toyokeizaia-22

    I tried to buy this article (633Yen) with my amazon-account but it doesnt work. Has somebody an international amazon-account and is able to get this magazine for us?
    Tsuji says in this article when the trial will start this year.(Before COVID-19)

    1. JAn I’m interested in reading that but I can’t buy it. Maybe if nobody here can buy it, Admin can contact https://twitter.com/FKagurazaka Japanese hair loss blogger he could buy the article and then he post it online just the tsuji full section and we translate it.

          1. Thank you Admin for contacting FUji! Did he answered your message?

            https://www2.bdr.riken.jp/renkei/2020/

            Takashi Tsuji will hold a lecture on 05/08/2020
            11:30-12:30 “Takashi Tsuji Organ regeneration by self-organization of stem cells” – it is a ZOOM conference

            Can you please ask Fuji or the Youtuber or any other Japanese to go there and give us the content of the lecture?

  10. Just scrolling for mjones take.
    When I see histogen I think of me in 2013 getting happy because Gail said it was coming out in a two or three years. Since that fall I have gone from n1 to n5 thinning. still that treatment even if released couldn’t save me now.

  11. Clascoterone cream “1%” from Cassiopea is currently going through phase 3. Clascoterone is the same active ingredient they are using in their Brezula solution to treat MPB, I wonder how the two product differ from each other.
    Once again HOPE is the key word here…
    Hope never dies… meanwhile our heads are going bald…LOL

    1. It finished phase 3 ages ago and has applied for FDA final approval who have until about July or Aug I think to respond..

      There is not much difference other than breezula being 7.5% concentration

  12. Hi Egghead. Hope all is well bro. You know my take on histogen lol. I was just like you in 2013. Propecia was holding strong. Nice density nw1.5. I was excited that it was supposed to be released in 2015. Then the bs started and I gave up on them. I dont consider them a player. Too much bs and use of shady ht docs to push promotion. F that. If it ever comes out great but doubt we’ll see it before 2027. They should have pushed the Fda to let them start a phase 2b and kick off phase 3 in 2021. Now we are back to square 1 with these histogen guys.

  13. My unsolicited take on Gail’s Golden Goose? Probably more chance Earth will be hit by a giant hairy asteroid before old Histo makes it to market. Hope I’m wrong tho…

    1. Only if you are a rodent I guess …
      The ingredients make sense and it’s pretty cheap, why not try it?

      I have the same questionmarks concerning Foligain Topical DHT Blocker incl. 12% Trichogen. They also included ingredients that make sense, however I don’t see a lot reviews online …

  14. I signed up for the clinical trial, and just completed my second visit. They took my baseline photos and did some injections.
    There’s a 30% chance I got sorted into a placebo group. But if I notice anything significant, good or bad, I’ll be sure to post.

    1. So it’s been 6 weeks and you’ve probably gotten the 2nd injection now…notice anything? Or did they see anything with the pictures?

  15. This is pissing me off! can we get a real company working on AGA that doesn’t give us s results! and doesn’t have financial problems! Its just a never ending pattern these companies working on AGA take like 50 years to go through clinical trials or they take like 50 years in preclinical and then go bankrupt and the results are ALWAYS a joke.

  16. I wonder if they only tried the therapy on the vertex or if they tried on all parts of the scalp. I’m tired of these companies not coming up with something that is effective on the hairline and temple region.

  17. Wolfy stop thinking a working mpb treatment will come out. The past 20 yrs has produced nothing but snake oils and false promises and shady ht docs. The same will occur for the next 20 yrs. Expect crap treatments that grow a bit of hair and that’s it…maybe a Norwood of growth at best. Histogen is a lying company plain and simple. Phase 3 then stopped with a successful treatment then kick started a new better version for phase 1 which didn’t produce any statistical results haha. I mean come on….this screams out fraud. I’m pissed the stock price went down. Why couldn’t they just fake the results they did the first time a few years ago so I could cash out lol. Aholes!

  18. So it produced new hairs but so few that the results were statistically insignificant? Is that what they’re saying?

    1. I think so Ralph Wiggum. The full read out is in q1 when the 26 weeks is up. Only thing we can hope for is the regrowth kicks in later on towards the last few weeks of the trial. What pisses me off is that they supposedly had a working treatment in phase 3…..then they scrap it to use this non effective new version? I mean wtf is going on at the company? Just fund the final phase 3 with the original treatment and put on the market. I mean how hard is that to follow….unless the treatment never worked and all the pics were photoshopped and they are a bs company….

      1. It was all bs. Of course they never had a working treatment, why would you abandon it otherwise. There a shady snake oil company like the rest of them.i don’t know why people keep putting their faith in these companies. My guess is if a treatment ever comes out (a cure never will) it will be a accidental find.

    1. I agree with this sentiment. When the final results are out I would like to see placebo vs treated. If treated stay at baseline but placebo lost hair and the difference is significant, that would be massive. Something that stops hairloss without major side effects would be a huge deal. People would no longer have to go bald in the first place, and those of us who already have hair loss could get transplants without fear of losing the remaining hair around the transplanted hair. I don’t need something to grow my hair back, I just need something to stop me losing any more

  19. Pffff I’m done with this, there will never be a real cure. Just getting my hopes up for nothing. Microneedling is the only thing that works. Dr tsuji failed histogen failed replicel failed.!

    1. Marc I never believed in replicel I thought it was a fraud when I first watched that 2012 video of the animated guy growing a full head of hair just a marketing hype fraud. Now my only hope left is stemson because of 7mill investment and the U.K. regulatory past using “specials” its the only hope guys literally. If stemson fails it’s over. As for tsuji stemson needs to take notes that’s what happens when you never test on a human and take 8 years…

      1. Woofy97 I’m on board with you, let’s have what’s left of hope to stemson therapeutics . Side note this has been the worst year of news for hair loss, after years of waiting patiently for 2020 . What’s your opinion on tissuse, in my humble opinion tissuse made too much of a bold statement saying that there hair cloning will be out in a couple of years. That’s what Dr tsuji said and Replicel and histogen they all failed. To be honest were gonna have to go to mars first and through space exploration new technologies will come through, that’s what I’m hoping for or the Chinese communist party well cure it, they already cured aides

      2. Histogen has and always will be a maintenance treatment. 10 years ago I’d be happy as hell if there was a side free maintanance procedure. I’m too far gone now but heck there are many that are in the same shoes I was. I say good for them if this comes out.

    2. Well, the latest news on Crispr and Moogene Medi is very promising. Stemson is very much on track. And what is the evidence that Tsuji has “failed”??

      1. He never attempted human trails he wasn’t even close to starting human trails. He lied about everything, and I never trusted youngjet, I was like why is admin the webmaster believing this guy he looks like a clown c’mom give ME a break.

    1. And they can make it in 10 months start to finish but can’t find even a safe and fully effective topical and localised DHT blocker in 30 bloody years

  20. I mean Histogen didn’t fail they have a product that clearly works if you look back at those pictures from previous trials like the dark haired guy his results looked very good and also this one women with blonde hair injections in frontal side results looks amazing so they have a good product that has shown to give good results. Maybe they should go back to the old serum? Or maybe they need to keep tweaking this new serum. Idk let’s just hope Histogen doesn’t run into anymore money problems. And Marc I agree this is the worst year for AGA news. :(

    1. Woofy97 I think it’s time to start thinking about a hair transplant wether f. u. t for your Norwood 5 or f. u. e for my Norwood 2 , but either way a real hair loss cure is truly decades away even Dr diep told me that

      1. Marc I wish. I have been thinking about getting a hair transplant for 4 years now but I’m scared because of the aggressive nature of my hair loss and pattern I showed Dr Rassman my two uncles on my mothers side hair pictures and he told me they were both nw7s but my dad is like a 5 or 6 he still has a good amount of hair on his head. I’m just scared if I get transplant to early it could go south a couple years after transplantation. Dr Rassman and other Doctors advice not to get transplant if you’re younger then 25 or 26. So I’m screwed the only thing saving me right now is Finasteride. If I was going to do a transplant I’m going to hasson and Wong for the lateral slit technique with FUT. I would consider going Bernstein medical also they do Lateral slit technique FUT but they wouldn’t do surgery on me Dr Bernstein doesn’t do surgery on patients with early hair loss. I’m stuck in a corner and I can’t get out.

  21. I also don’t want keep coming back to these hair loss websites forever no offense admin like you but I can’t do this forever. I just to move on but can’t. I will never except my hairloss but I just want my old life back when I was happy. September 2015 AGA ruined me.

  22. I’m sure that in the next 2-3 years something will come out but surely none of the companies mentioned in this blog will have anything to do with it, it will be another case like finasteride, one day suddenly a new drug will come up, hopefully with less side effects and that it works better.

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