So Histogen was likely the biggest joke in the history of anticipated hair loss treatments. Worse than Aderans and Intercytex. Worse than Aclaris. They fooled us twice over the course of 14 years since inception. Most companies (e.g., Kythera) fold their hair loss program or their entire operations much sooner.
Histogen Ends its HST 001 Program
In recent years, I essentially gave up on Histogen, but still wrote the further below clinical trial update post in February.
“We will suspend development of this (HST-001) program. We believe the best business decision at this time is to redirect these resources towards our high value orthopedic programs.”
The only positive is that most readers did not have high hopes of Histogen’s hair loss treatment being that effective. So this is not a big disappointment, even if we did not expect such a sudden cessation.
I do wish I could get back the time I spent in writing over ten posts on the company since this blog began :-(
HST 001 Clinical Trial Update
Feb 16, 2021
In 2012, Histogen announced 24-week results from their Phase I/II clinical trial of their hair stimulating complex (HSC). This product is also known as HST-001 and used to treat male pattern hair loss.
In 2021, Histogen just announced 26-week results from their Phase 1b/2a clinical trial of HST-001.
Mockery aside, CEO Richard Pascoe said that a larger clinical trial will commence in the second half of 2021.
It seems like the hair stimulating complex works well in growing some hair in men with androgenetic alopecia. However, just as with the week 18 results, the placebo group also witnessed similar increases in hair count. There were no significant issues with safety or side effects.
I cannot be bothered to find out if some in the placebo group were using any kind of hair loss treatments such as Minoxidil. Most likely, that would not be allowed.
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
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.
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.
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.
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.