Follicum, FOL-005, Osteopontin

Follicum Phase IIa Trial Results Disapppoint

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Update: May 6, 2021

Disappointing Results from Follicum FOL-005 Phase 2 Trial

Follicum just released top-line results of their Phase IIa study of FOL-005 for the treatment of hair loss. The results are disappointing.

“In those treated with the highest dose of FOL-005 studied, hair growth increased by 6.6 hair/cm2, compared to 5.6 hair/cm2 in the placebo group.”

The difference between the treated group and the placebo group was not significant. While I never expecting this treatment to be anything much better than Minoxidil, I was still hopeful. Follicum has been extremely professional and fast in its trial progression and updates since I first started covering them in 2015.

In any case, it is also rare for a company in the hair loss world to give us disappointing news in an honest manner. A number of other hair loss companies in the past (and present?) tend to extend their importance beyond a decade. Then they ultimately fold or go out of business.

Update: October 9, 2020 — Follicum has completed its over 200 patient enrollment in its Phase IIa trials for FOL-005. Treatment will finish in all patients at the end of January 2021. Results are expected to be announced in Spring 2021. So far, no adverse effects and no patients have discontinued with their participation in the trials.

Follicum Trials to Restart

June 8, 2020

Follicum chief business office Mr. Gunnar Gårdemyr just sent an encouraging e-mail, part of which I am pasting below. Note that these Phase IIa trials entail topical application of FOL-005. In two prior trials, FOL-005 was administered via intradermal injections.

“Some good news. We will restart the clinical Phase IIa study with a cream-like formulation of FOL-005 this month, following a pause due to the Covid-19 pandemic. To increase the recruitment rate, we have contracted a third study centre. The study comprises approximately 200 male patients with hair loss who are treated daily for four months with the newly developed formulation of FOL-005 or placebo.

The study is being conducted at the Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin; proDERM in Hamburg; and the new center, CentroDerm in Wuppertal. The patients themselves will apply a cream with three different strengths of FOL-005 or placebo in the scalp, once daily in the evening. The study is expected to be completed and the results communicated in spring 2021.”

Follicum FOL-005
Follicum.

February 1, 2020

I have written about Sweden-based Follicum and its FOL-005 hair growth product numerous times. Several days ago, Follicum’s CEO Jan Alenfall announced that German authorities have granted the company approval to commence Phase IIa clinical trials for FOL-005. The go-ahead was granted by the German Medicines Agency (BfArM) and the German Ethics Committee.

Also see this recent article titled: “The rise of therapeutic peptides: Follicum at the forefront.” Key quote:

“Peptide-based drug candidates are more likely to reach the market compared to small molecule drug candidates.”

Follicum Phase IIa Trials in Berlin and Hamburg

The trial will comprise about 200 patients who will be treated with topical FOL-005 or placebo daily for 4 months. Results will be released in the fourth quarter of 2020. The upcoming phase IIa study will investigate the safety, efficacy and response to a topical formulation of FOL-005. Note that in 2018, an injectable version of FOL-005 produced a good safety profile and hair growth results.

The press release states that patient recruitment will start soon. I contacted Follicum to see if any of this blog’s European readers would be able to volunteer as test candidates. However, the company’s chief business office Mr. Gunnar Gårdemyr replied in the negative. He said that all 200 test male patients for the trials have now been recruited and are from Germany.

The trials will be conducted at:

  1. Charité Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin. A highly reputable institute that I have covered in the past on this blog.
  2. Hamburg-based proDERM, which just celebrated its 25-year anniversary. The have an interesting website section on hair care and hair removal.

About FOL-005

According to Follicum, FOL-005 is a proprietary peptide. Its development was based on research involving the human protein osteopontin. FOL-005 is a shorter sequence of osteopontin. The sequence has been slightly modified, but is still based on natural amino acids according to Follicum.

MTF Hair Growth, MTF Transition Hair Regrowth

Male-to-Female (MTF) Transition Hair Growth

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Even though I am not a transgender person, I have long been fascinated by men who become women. i.e., Male-to-Female (MTF) transsexuals. Note that nowadays, the term transgender seems to be preferred to transsexual.

Hair Growth During MTF Transition

My biggest reason for this fascination is due to observing how such MTF transitioning people get much better scalp hair. I am also curious to see how much body hair reduction happens in those who are transitioning. In particular, beard growth slowdown.

Scalp hair loss cessation and regrowth happens once MTF patients start estrogen, anti-androgen (e.g., Spironolactone) and other hormone replacement therapy (HRT) treatments. Some do not even take Finasteride or Dutasteride and still get much improved scalp hair growth. A select few get tremendous hair regrowth.

Many people assume that hair cannot regrow once it has been lost. Especially if the loss happened many years ago. However, reversing hair loss and regaining hair in totally bald areas of the scalp is possible.

If a MTF transgender person completes the full transition process, he will also get the orchiectomy testicle removal procedure. Thereafter, further androgenetic alopecia type hair loss stops entirely. This is due to the lack of dihydrotestosterone (DHT) production and drastic reduction in testosterone production.

Sona Avedian

Sona Avedin MTF Before After
Sona Avedian MTF Before After. Source: Facebook.

In the second half of this post, you can see some incredible before and after transformations of scalp hair in MTF trans persons. All have been verified as legitimate.

Previously, my favorite  MTF transformation was of Sona Avedian. Her before and after image on the right is astounding. Like many men with excess body hair, Sona also suffered from scalp baldness.

Many newspapers covered her story since she was a former US marine. However, according to one post on Sona’s Facebook page, she wears a hair system :-( So although not my favorite transformation anymore, Sona’s new look after transition is still astounding.

Side note: When a woman decides to become a man (FTM transsexual), the result can often lead to baldness. The testosterone supplements can cause hair loss in those that are genetically susceptible.

Caitlyn Jenner’s Hair

This week Caitlyn Jenner (previously, Bruce Jenner) is in the news again due to her running to be the next California Governor. And being misgendered.

At age 71, Ms. Jenner has phenomenal hair that does not look fake to me in the below recent video. I am nevertheless going to assume that it is not entirely real, especially the color and length. Some articles on the web suggest that she might have had a hair transplant or hairpiece in the past.

Spectacular Hair Regrowth in MTF Transgender People

Nowadays, societal norms make it much easier for a very young person to transition from male to female (or vice versa). In many cases, such young people reverse their hair loss and even regrow most of their recently lost hair. For middle-aged people such as Danielle Hallet, hair transplants are often required to get back a decent hairline.

Below are some of the best MTF transition hair regrowth examples that I have seen on the web. Make sure to click and scroll through the below links in their entirety for further closeup shots. Most of these people have a presence on Reddit as well as on Imgur.

The below person has more photos on Imgur:

I wondered if I would make it to 30, now I look forward to the future for the first time ever (1 year hrt)
by intranstimelines

The below person was almost entirely bald for 3-4 years, and the regrowth is real (not a hair system) per his comments. He was on HRT for 14.5 months.

I didn’t think this was going to work, but I think it is safe to say that it did. 14.5 months hrt.
byu/neederbellis intranstimelines

The below person (Bree) has a detailed thread on HLT with a timeline of treatments and regrowth. You can swipe on the white arrow on the right to see all 14 images.

Hair loss recovery

The below person also has a lengthy thread on HLT regarding the power of super aggressive regimens. You can swipe on the white arrow on the right to see all 22 images.

View post on imgur.com

This before and after on Reddit is hard to believe at all. We live in a strange world and you never know what you will get.  For example, this muscular body builder decided to transition into a woman. The longer and thicker new scalp hair growth is impressive.

There are dozens of such examples on the web. Feel free to share the ones that you like the most. I am especially interested in a discussion of the treatment regimens that each of these MTF persons takes. Especially if they see great results before orchiectomy.