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 trials on humans (2016/2017)
- Development of topical formulation 2017/18
- Clinical phase IIa trial on scalp (2018)
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 our forthcoming clinical study the objectives is to reproduce our results from earlier trials concerning efficacy, safety and response on human scalps through injections of FOL-005. Furthermore we aim to develop a suitable topical formulation of our substance which is both attractive and easy to use for patients.