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 and identification of topical formulation (2018)
- Clinical phase IIa trial on scalp on patients with alopecia (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 people 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).
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.
In parallel to our clinical development of FOL-005 we also investigate the mechanism of action, where the first parts have been confirmed. 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.
New peptide class for treatment of diabetes
Our new peptide class stimulates insulin release and has the potential to be a valuable complement in the treatment of diabetes. During the past year, we have carried out a variety of preclinical studies that have shown that Follicum’s peptides have insulin-releasing effects that are comparable to, or even better than, existing diabetes treatments. Moreover, insulin release is potentiated with increasing glucose concentration in in vitro studies. The potential of the peptides has also been confirmed in glucose tolerance tests where they have a glucose lowering effect in experimental animals. The market for diabetes-related drugs is huge and very competitive. Therefore, we are focusing on identifying factors that can differentiate us from competitors and thereby lead to an early partnership engagement.
During the autumn 2018, we strengthened our diabetes’ patent and submitted an updated application to the patent authorities at the beginning of November. The preclinical work is carried out in cooperation with Follicum’s research network at Lund University.
The preclinical results demonstrate the ability of peptides to delay the onset of Type 1 diabetes in an animal model. The results further clarify that the peptide specifically distributes to the pancreas, which is beneficial for an insulin regulating drug because the pancreas is the body’s center for insulin production.
The next objective in the diabetes project is to select a drug candidate in early 2019 and to begin preparations for a Phase I study planned to commence at the start of 2020. The goal is to run a diabetes project that is attractive to global partners.
Participation in an international diabetes project
Follicum is part of a comprehensive diabetes project led by Lund University since 2017, funded by the Foundation for Strategic Research. In addition to Follicum, Scandinavia’s largest pharmaceutical company Novo Nordisk, Johnson & Johnson Innovation, Probi, CardioVax, Region Skåne / Skåne University Hospital, and the world’s third largest pharmaceutical company Pfizer are participating in the project. This collaborative space provides valuable contacts and opportunities for networking at the highest international level. We are also very pleased that the Novo Nordisk Foundation awarded Professor Jan Nilsson’s research team at the Clinical Research Center at Lund University with in total DKK 1,400,000 in 2017/18 for performing preclinical diabetes studies with Follicum’s peptides.