Follicum Announces Data From Phase 2A Scalp Trial

(Updated Below)

As the company promised to do earlier this month, Follicum has released data from its phase 2a study which concluded in August earlier this year.

This was the first trial Follicum conducted using FOL-005, a modified peptide, on human scalps. In this recent scalp study, five doses (including placebo) were evaluated where patients received three injections per week over the course of a three month period. Previously, a phase 2 trial of FOL-005 showed an increase in hair growth on the thigh area in humans. Today, Follicum reports via press release that an increase in hair growth was observed in the highest dose group of its latest human scalp trial. 

Here are the highlights from Follicum’s Phase 2a Data Announcement:

• FOL-005 increased hair growth by an average of 7 hair per cm² in the study.
• The study measured patient response in terms of “after treatment” vs baseline, rather than “after treatment” vs placebo.
• In the highest dose group, an 11% increase of hair follicles in growth phase was observed (group average) .
• The ratio between hair follicles in growth phase to hair follicles in dormant phase increased by 18% (group average), while the ratio in placebo group showed a decrease of 16% (group average). This indicates FOL-005 stimulates anagen or growth phase.
• Follicum plans to move forward with its next phase 2b study using a newly developed topical version of FOL-005 in different dose and frequency of application ranges.

To view the official press release from Follicum, please click here. 

Update: Follicum Releases Interview On Trial Results

Following the press release of the phase 2a trial results earlier this week, Follicum has also shared an interview conducted with CEO Jan Alenfall and the media organization BioStock. In the interview, Jan elaborates on the specifics of the trial and adds perspective on Follicum’s plans to move forward. Below are two pertinent quotes from the interview:

“Hence, the results showed an increase in both the total number of hairs as well as in the number of hairs in active growth phase which indicate that a larger increase in hair density could be observed with longer treatment periods…..The treatment effect on hair density at the highest dose was slightly weaker than in the previous study and no obvious effects were detected at the lower doses. Therefore, we plan to increase the dose, as well as the dose frequency in upcoming studies. In a pivotal study with the topical formulation, we will also extend the treatment and follow-up period.”

“We expect to start a topical hair study at the earliest in late fall 2019, and in the meantime find a commercial partner to continue the clinical development of FOL-005.”

I was surprised at that timeline for the start of Follicum’s next trial due to the fact that they had completed all previous trials with great expediency. However, I’ll take it and I have hope that the timeline could speed up if they find the right industry partner. To view the entire interview with Jan Alenfall of Follicum click here.