Follicum’s research and development is currently focused on the stimulation of hair growth and diabetes. Following our basic research related to arteriosclerosis our founders observed an increased hair growth in mice, from the modified human protein, osteopontin. The research has since been focused on human proteins from which we develop our drug candidates(peptides). The peptide in the lead of our hair research, FOL-005, has significantly shown effects on human hair growth. Hair loss and unwanted hair growth affects millions of people around the world, both men and women. In many cases this is traumatic for the individual concerned.
What have been the milestones so far in your company development?
We are very proud of that we have been able to rapidly advance FOL-005 for hair growth through pre-clinical development and then performed two successful phase I/IIa studies on time and on budget with limited resources. In addition, we have successfully developed a new topical formulation especially targeted to FOL-005 and alopecia. We have also recently started to pursue a diabetes track where we might have the opportunity to treat diabetes and complications to diabetes. Both programs are patent protected and represent a significant commercial potential. FOL-005 – Trials on mice (2012) – Trials on human tissue in-vitro (2013) – Trials on human tissue transplanted on mice (2015) – Toxicity trials (2016) – Clinical phase I/IIa trials on humans (2016/2017) – Development and selection of topical formulation 2017/18 – Clinical phase IIa trial on scalp in alopecia patients (2018) – Animal effect data with topical formulation (2019) Diabetes peptides – In vitro trials (2017-) – In vivo trials (2017- )
What are your most important markets, segments and customers?
The competition within the hair growth area is limited. No new treatments for alopecia have been approved during the last 25 years. There are a limited number of substances undergoing clinical development, but the competition from these is small as the development of many of these products has stalled. Today alopecia is mainly treated with one of two products – minoxidil (Rogaine) and finasteride (Propecia). Minoxidil is an over-the-counter product for both men and women but only 1/3 of patients respond to the treatment. Finasteride is a prescription medication for men only and 80% of patients respond. Both of the existing treatments are associated with side effects such as skin reactions, diminished sex drive, and erection issues. The pharmaceutical hair growth market is estimated at more than 3 Bn $ today and expected to increase to 6 Bn$ by 2025. Hair loss in numbers – >95% of hair loss in men is hereditary – 25% of men in their 30s experience hair loss – 67% of men in their 60s experience hair loss – For ¼ of men with hair loss the process starts already in their 20s – 30% of women in their 50s experience hair loss – 40% of individuals with alopecia in the US are women Diabetes affects close to 500 million people worldwide, and the global prevalence among adults has more than doubled since 1980, from 4.3% to 9% in 2014. These numbers are not expected to come down any time soon, which means the economic burden on society will only get worse. According to the American Diabetes Association, global healthcare costs related to diabetes are estimated to double by 2030, reaching close to $2.5 trillion. Much of the cost is due to serious complications such as heart attack, stroke, nerve damage or kidney disease caused by the underlying inability of the diabetic patient to absorb sugar (glucose) from the blood and use it as energy to the surrounding cells of the body.
Where do you see the company five years from now?
My vision is to complete the upcoming Proof-of Concept phase II clinical trial with FOL-005 topical formulation on alopecia patients successfully and subsequently out-license the product on a global scale. For our diabetes project I would like to enter into a scientific or commercial deal with a leading diabetes company to accelerate the development further. If we can do this, I believe there are many more areas that we as a Company can pursue within the field of tissue repair. Many of diabetic complications as well as defective hair growth are consequences of impaired tissue repair which is a field where the Company has vast experience.
What are your priorities within 2019/20?
We focus on starting and completing the phase IIa clinical trial with FOL-005 topical formulation on alopecia patients and to further strengthen our pre-clinical data on diabetes complications.
Why should one consider adding your company into their portfolio?
Follicum is working within two fields with an enormous market potential with a huge unmet medical need. We have short term milestones that are very tangible which we believe will generate important shareholder value in 2020 and we have always delivered according to what we communicate.