With FOL-005 we have developed a drug candidate which, in both pre-clinical and clinical trials, has shown potential to regulate hair growth.
Both stimulation and inhibition of hair growth
In pre-clinical models both stimulation and inhibition of hair growth have been observed. These two different effects may be due to the phase of the hair growth cycle or which treatment model has been used, as well as the dosage administered. Both effects are seen after low doses of FOL-005 are administered, and both have significant potential – from a medical and commercial point of view.
Follicum is a virtual biotech company. Since our start-up in 2011 we have been devoted to developing efficient and safe drugs for the regulation of hair growth. Throughout our pre-clinical and clinical trials, we have followed our projections and presented results on target. We work with a wide range of professionals and specialised partners in research, clinical trials, formulation development and production. Teaming with leading research groups, in Sweden and abroad, we also have a Scientific Advisory Board comprising well-known scientists in the fields of hair growth, dermatology and diabetes.
Clinical phase for stimulation of hair growth
Follicums main objectives for the development of FOL-005 are clear: to stimulate hair growth on men and women suffering from alopecia with better response and effect compared to existing products on the market. The first phase of our clinical development, the phase I/IIa trial carried out in 2016/2017 demonstrated impressive results, see FOL-005. Our continued work after the trial has been focused on the topical formulation of the drug, as well as preparing for a new clinical phase II trial – this time on human scalp. Our objective is to document and register an efficient drug in a topical formulation initially to be sold as a prescribed drug, but later maybe also as an OTC-drug (non-prescribed).
The market for hair stimulation is immense. Inheritence factors represents more than 95 % of male hair loss. As early as at the age of 35 two thirds of all US males experience hair loss and after the age of 50 the number grows to 85 %. Also a large number of females experience hair loss. Of all persons with hair loss in the USA roughly 40 % are women. Thus, the need for efficient and safe products is high.
The global alopecia market was estimated to 7,3 BUSD in 2015, of which pharmaceuticals represented roughly 50 %. Already in 2024 the market is forecasted to be close to 12 BUSD. The largest market is the USA. Among existing pharmaceuticals on the market we find the market leading substances finasteride and minoxidil (since some years generic substances sold under different product names), not all to efficient and with some side reactions.
We believe our product will prove to be efficient, give better respons rate, as well as offer an easy and attractive administration and much fewer adverse reactions than present products on the market.
During recently conducted pre-clinical trials in vitro, in order to understand the mechanisms of FOL-005, another substance, FOL-014 (based on another human protein than FOL-005), demonstrated an increased release of insulin from the pancreas of mice. The results were convincing and further pre-clinical trials will be carried out in cooperation with a research group at the University of Lund, Sweden (Lund University Diabetes Center).
Folllicum has also been invited as partner in a very comprehensive research project on diabetes at the University of Lund – financed by the The Swedish Foundation for Strategic Research with 100 MSEK (12 MUSD) over several years. Furthermore, the research was recently granted funding of 400 TSEK (45 KUSD) from the Novo Nordisk Foundation for continued development of FOL-014.
Diabetes is a worldwide epidemic. A huge majority of diabetes (90 %) are caused by an un-healthy diet, smoking, alcohol and inertia. This version is labelled as Diabetes type 2. A smaller part of the “diabetes-population” are often younger persons with an autoimmune condition called Diabetes type 1. The World Health Organisation, WHO, estimates the number of individuals with diabetes to more than 420 millions world-wide. Within twenty years the number of people with Diabetes type 2 will double. There is a huge number of untreated diabetes patients as well. The cost of Diabetes type 2 in USA (treatment and reduced productivity) was calculated at 250 MUSD annualy (2015).
Among existing drugs for diabetes on the market, the leading ones are called GLP-1 analouges (Glucagon-Like Peptide-1), which are estimated to grow their sales by more than 12 % the coming ten years. The market leader today is the brand Victoza from Novo Nordisk, focused on Diabetes type 2, a so called non-insulin therapy. The market share of Victoza is estimated at 60 % in this segment with sales exceeding 2,2 MUSD during 2016.
Our business strategy
We intend to license or divest our projects to major pharmaceutical companies during the clinical trials period limiting our investments and generating income and value to our stakeholders.