Follicum Phase 1/2A Hair Growth Results

Two days ago, I received an email from one of my readers which informed me that Follicum had just made an announcement about important developments that would be of interest to me. Upon further investigation, I found the Follicum website (only on the “Swedish” content) had put out a press release pertaining to the results of their candidate FOL-005 in its latest phase 1/2a trial.

The peptide, FOL-005, has shown a statistically significant increase in hair growth in its latest trial on humans. This was actually somewhat of a surprise to all those who were watching this development carefully. The CEO of Follicum, Jan Alenfall, had stated before the trial began that the company expected to observe the inhibition of hair growth in this trial. Pleasing to most of us, the peptide pulled a bit of a switcharoo, and produced the stimulation of hair growth instead. For those just joining the conversation on Follicum, the peptide FOL-005 has shown the ability to both inhibit and stimulate hair growth in its preclinical trials. The company is now furthering the development of FOL-005 through clinical trials to better understand and produce each of those effects in the desirable situations thereof.

What’s it Looking Like?

In this phase 1/2a trial, FOL-005 showed an 8% increase in hair growth in people who received the treatment. The treatment was administered by injection into the front thigh area of the trial subjects. Those who received a placebo injection in the trial showed a decrease in hair growth of 2%. There were no adverse events reported from those who received FOL-005. As far as I can tell from this press release, the subjects received injections twice per week.

So, 8%…..what does this mean? Is this good?

Here’s what is relevant to the stats and the design of this trial:

  • This study was completed over a 3 month time period. That is a small window of opportunity to observe an increase in hair growth due to the time involved in the hair growth cycle itself. How much hair growth could be observed over 6 or 9 months, then?
  • The biological area which was treated in this study was the thigh. I just took a moment to look at my own thigh. Yes, there is a lot of hair growth there (laughs), but not the same as a scalp, obviously. There is a chance the peptide could behave differently (potentially better) when used on the scalp.
  • There were 4 dosing ranges being tested in this trial. The second lowest dose showed the best response. It appears that this drug shows a dose-specific response similar to Samumed’s drug. What is more pertinent, those doses of FOL-005 that were used in this study and found to be non-optimal, affected the statistics, which came out to be an 8% increase in hair growth. What could the % be if the whole group was treated with the optimal dose?
  • The press release mentions the data from this trial indicates that changing the dosing frequency to three times a week or more, could further improve results.
  • This trial has provided Follicum with information on how to improve upon their formulation.

You knew that the optimism was coming, and it’s deserved. Things are still early here for FOL-005 with more to come.

Moving Forward

Jan Alenfall states at the end of the new publication that Follicum is now getting things together for FOL-005’s phase 2 trial, also the company will be focusing on creating an optimal formulation for their peptide (which may include nanoparticle delivery), and notably, the next trial will be administered on the scalp. Good news to hear, for now.

This is the link to the press release, now posted in English.

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