Author: Sarah Belgravia
Signs of progress have been reported at Follicum, the Swedish biotech company currently developing a peptide-based drug to treat genetic hair loss in men and women.
In a company press release dated 8th May 2019, Follicum revealed its lead candidate – an injectable hair loss solution known as FOL-005 – has received additional protections via the award of an expanded European patent.
It states: “With EPO’s grant of patent no. EP 3087999 B1, there is now broad protection for Follicum’s peptides in Europe until 2032. The patent that protects the company’s peptides generally as a product, and for the stimulation of hair growth specifically, is a broadening of the previously granted, first patent on FOL-005. The patent covers the drug candidate FOL-005 and related substances.”
Follicum has also filed a patent application for a topical version of the FOL-005 formulation.
Developing FOL-005 hair growth treatment
Follicum’s FOL-005 is a novel solution which contains peptides shown to stimulate hair growth. It has been in development since at least 2012, when the first mice trials took place. The original version is injected directly into the scalp although a topical cream formulation is also now being tested.
The initial mice trials in 2012 showed what the company describes as “considerable stimulation of hair growth”, whilst the follow-up human tissue in-vitro trials in 2013 demonstrated that high doses of FOL-005 influenced inhibition of hair growth. Further trials in 2015, where FOL-005 was tested on human tissue transplanted onto mice, confirmed these findings.
Three-month toxicity trials in 2016 all reportedly “showed that FOL-005 was safe”.
Clinical phase I/IIa human trials using injections of FOL-005 took place in 2016 and 2017 at the Charité Hospital of Berlin, before a topical formulation was developed in 2018, when a clinical phase IIa trial of scalp applications on patients with Male Pattern Baldness or Female Pattern Hair Loss also took place.
This first Berlin trial saw increased hair growth in 76% of the healthy trial participants; an 8% boost from before FOL-005 treatment. It was noted that the “increase is statistically ensured (p=0,0038, not adjusted for multiplicity)”.
The second, 2018 clinical study, where FOL-005 was tested on patients with genetic hair loss, was a multi-centre trial conducted at both the Charité Hospital in Berlin an bioskin, Hamburg.
These findings also showed participants experienced accelerated hair growth during the trial, with an average increase of 7 hairs per cm2. This was considered borderline statistically significant compared to baseline (p = 0.078).
Follicum explains, “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 [androgenetic] alopecia (hair loss), although the dose and treatment length will probably need to be optimized to obtain maximum effect.”
In December 2018 a partnership was announced between Follicum AB and the Centre for Skin Sciences at the UK’s University of Bradford (CSS). This was formed so both institutions could collaborate on the development of treatments for hair loss and for diabetes, including further work on FOL-005.
An 11th December 2018 press release from the University of Bradford, advised: “The aim is to combine in vitro experiments with the use of bioinformatics data mining and analysis to investigate the mode of action of Follicum’s different peptide classes using an in silico approach (big data analysis).
The project will bring together the CSS bioinformatics capabilities, using open data analysis platforms, with its world-class cell and molecular biology expertise in skin and hair biology.”
The company then presented a poster detailing its clinical trial data so far at the 11th World Congress for Hair Research scientific conference in Barcelona, in April 2019.
Follicum yet to give release date estimate
According to the Follicum pipeline, as of May 2019, FOL-005 is at the Phase II trial stage for the version administered via scalp injections, and in pre-clinical stage for the topical cream formulation.
The company’s aim is to produce a rival to the current MHRA-licensed and FDA-approved hair loss treatments and offer a safe, effective and convenient hair growth treatment with a low side effect profile.
There are no official release date estimates as yet from Follicum, most likely due to the on-going clinical trials which still need to be successfully completed before the findings can be submitted to the relevant medical regulatory bodies in each country eg, the MHRA and FDA in the UK and USA, for approval prior to release.
Updates on the FOL-005 release date and development process will be posted on the Belgravia blog as they become available.
The Belgravia Centre is an organisation specialising in hair growth and hair loss prevention with two clinics and in-house pharmacies in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the world. View our Hair Loss Success Stories, which includes the world’s largest gallery of hair growth comparison photos and demonstrates the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time to arrange a free consultation.