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 the hair growth is stimulated with 8 % in 76 % of the individuals 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).

Further steps in the clinical development of FOL-005 is to go through with phase II and phase III trials. The first of these, a phase IIa on human scalps, will commence early 2018. We are also running a project that will decide which topical formulation of our drug we will use in the phase IIb clinical trial . Our research follows several different tracks in order to understand if an ointment, a cream or a formulation with dry powder will be the optimal choice. Prototypes have been developed and are currently tested. The chosen formulation will then be tested in clinical phase IIb and III trials before the launch of our drug.

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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.

The recently conducted 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 the 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.

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 eas 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.

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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.