FOL-005 for stimulation of hair growth
Follicum has, in collaboration with international R & D partners evaluated FOL-005 in different models for regulation of hair growth – both in preclinical models 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.
During the period from late 2016 to early 2017 the first clinical trial was carried out on healthy humans at the Charité Hospital of Berlin. The main objective of the trials was to confirm the safety of the drug, FOL-005, but also to measure effect. The trial showed, first of all, that the treatment was safe, but also a considerable increase in hair growth. 76% of the trial persons responded with increased growth. At this specific dose, the hair growth was + 8% compared to before treatment. The increase is statistically ensured (p=0,0038, not adjusted for multiplicity).
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 parallel to our clinical development of FOL-005 we also investigate the mechanism of action. This will enhance our design of the pre-clinical models that we use to understand hair growth. With the ultimate goal being to develop substances for both stimulation and inhibition of hair growth.
FOL-014 for treatment of diabetes
Our most recent drug candidate, FOL-014 was discovered while doing pre-clinical studies to investigate the mode of action of different peptides. Early, in-vitro studies of the pancreas have shown a significant effect on the release of insulin. Based on these findings we have applied for a patent of a new group of peptides, of which FOL-014 is one.
In parallel with our continued work with FOL-005, we pursue studies of the effect of FOL-014, to test toxicity, safety and effect on humans.
The Swedish Foundation for Strategic Research, SSF, has issued a grant of up to 100 MSEK (8.7 MUSD) for diabetes research at the University of Lund. The main research will be conducted at the Centre of Clinical Research (CRC) in Malmö, spearheaded by Professor Jan Nilsson’s research group. Follicum is a partner with several other leading companies in this project. This will enhance our possibility to pursue the research in diabetes. Furthermore, the Professor Nilsson’s research group has been granted 400 KDKK (roghly 50 MUSD) from the Novo Nordisk Foundation for further pre-clinical trials of our substance, FOL-014.