Our drug candidate, FOL-005, is based on research on the human protein ostepontin. FOL-005 is a shorter sequence of the protein – a peptide. The sequence has been slightly modified but is still based on natural amino acids.
Follicum has, in collaboration with international R & D partners evaluated FOL-005 in different models for regulation of hair growth – both in-vitro and on humans. Our development process is briefly described below:
- Trials on mice (2012)
- Trials on human tissue in-vitro (2013)
- Trials on human tissue transplanted on mice (2015)
- Toxicity trials, three months (2016)
- Clinical phase I/IIa trial on the thigh with injection on humans (2016/2017)
- Development of topical formulation (2017/18)
- Clinical phase IIa trial on scalp with injection on patients with alopecia (2018)
- Clinical phase IIa trial with topical formulation on male alopecia patients (2020)
The initial trials on mice showed a considerable stimulation of hair growth. Following up with trials on human tissue (in-vitro) showed an inhibition of hair growth with high doses of FOL-005. Follow-up trials with human tissue transplanted on mice confirmed these results. All trials involving live animals have been carried out according to the highest standards of ethics.
Preparing for further clinical trials of FOL-005, Follicum conducted among other studies two separate three month toxicity studies during 2016. All studies showed that FOL-005 was safe.
Our continued work on FOL-005 will include further phase II and phase III trials, in order to confirm the hair stimulation effect, as well as studying possible dosages and topical administration of the drug.
In 2016-2017, the first clinical trial on healthy volunteers was performed at the Charité hospital in Berlin. The objective of the trial was to confirm the safety of FOL-005 and also, hopefully, to see an effect of the treatment on the thigh on the healthy volunteers. The results of the trial showed that the treatment was safe and that a great number of the healthy volunteers showed an increased hair growth on the thigh after being treated with FOL-005. At the second lowest dose, 76 percent of the treated healthy volunteers showed a higher density of hair growth. The results further demonstrated an increase of hair growth at this dose which is statistically significant at around 8% compared with growth before treatment (p=0.0038, not adjusted for multiplicity).
In 2018, the second clinical trial, this time on scalp on patients with alopecia, was performed at the Charite hospital in Berlin and at bioskin in Hamburg. The objectives of the trial wereas to confirm the safety of FOL-005, and also to hopefully see an effect after treatment on the scalp on the 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 hairs 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.
In parallel with the clinical development of FOL-005, an investigation of the mechanism of action (MoA) is ongoing where the first parts have been confirmed. Knowledge about the MoA provides valuable information about which preclinical models we should use in our hair research. With a deeper understanding of the MoA, we can also work more focused on developing new candidates for different types of hair loss, but also suitable candidates to reduce hair growth.