Clinical trials: Stimulation of hair growth

Clinical trials: Stimulation of hair growth

Follicum’s clinical phase I/IIa trial, conducted with healthy humans, shows that in one of the doses the hair growth is stimulated with 8 % compared to before treatment – an increase wich is statistically verified (p=0,0038, non-multiply adjusted). The data from our trial also shows a significant higher effect when comparing three to two times treatment per week. This indicates that the frequency of treatment is important to optimise the effect of the drug. Placebo showed a decrease of 2 % in growth (p=0,4613). A higher hair density was seen in 76 % of the second lowest dose-treated healthy volunteers.

This trial was performed on the thighs of men. The Follicum substance (FOL-005) showed effect on par with other, established drugs. It is important to note that this first trial was not designed to monitor the effect of the substance, and the treatment was relatively short (3 months). Despite this our drug candidate showed promising efficacy and responder results.

Follicum plans to start a POC (Proof of Concept) study with FOL-005 with the topical formulation on alopecia patients at the end of 2019/beginning of 2020.

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Clinical phase IIa hair stimulation. Thickness of hair after three months of treatment with placebo (PL) and four different doses of FOL-005 (D1-D4). The darker staples are individuals with hair stimulating effect and the lighter staple are individuals without active drugs. The red line clearly shows the bellshaped dosage distribution of FOL-005.

In our trial, see above diagram, the smallest dose showed a weak effect, while the following two doses showed high efficacy. The fourth dose showed no effect at all. This kind of dose distribution is not unsual and is defined as a bell curve response. The individual variations are very spread out – which is expected considering the limited number of individuals in this first trial.

During a three month’s period following the last treatment with FOL-005, we conducted a follow-up on safety and effect. During the follow-up, where no FOL-005 was administered, the safety is, as expected, very good. Approximately 2 % of the hair increase was preserved after three months post-treatment in the FOL-005 group. The result clearly shows that FOL-005 is well tolerated and with a positive clinical effect on hair stimulation.

The second clinical study was conducted in 2018 at the Charité Hospital in Berlin and at bioskin, Hamburg, Germany, on patients suffering from alopecia. The main objective was to confirm the safety of FOL-005, but also to ideally measure effect on scalp on the treated patients. In the study, hair growth (primary endpoint) increased on average by 7 hairs per cm2 and the increase was borderline statistically significant compared to baseline (p = 0.078). There was no statistically significant difference for placebo when compared to baseline. The study was designed to measure the effect after treatment vs. baseline (the individual’s starting value) and not vs. placebo. A clear positive effect was also shown in the number of hairs in growth phase, another very important parameter for hair growth. At the highest dose, a marked, 11% (median) increase in the number of hair follicles in growth phase was observed. Furthermore, the ratio between the number of hair in the growth phase to those in the dormant phase increased by 18% (median), while the corresponding number for placebo was minus 16% (median). This difference reinforces the other results, which taken together indicate that FOL-005 is a promising treatment for alopecia (hair loss), although the dose and treatment length will probably need to be optimized to obtain maximum effect. In the case of the placebo, the majority of the parameters showed changes in the opposite direction, i.e. weakened hair growth. The next step for the company is to prepare for a clinical study evaluating the effect of a topical formulation of FOL-005, where dose, dosing frequency and treatment duration will be optimized. In parallel, the company will focus on finding a suitable partner for further development of FOL-005.

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The cross section of the hair follicle shows treatment with FOL-005. Our substance is marked by red and clearly shows the binding to the cells. The green colour represents the membranes binding the different cell layers together. Blue is the cell core. In the middle the single hair is visible. The binding of FOL-005 clearly shows the impact on the follicle.