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.

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.