Frequently asked questions
Frequently asked questions
About our company
What is Follicum?
Follicum is a biotech company focusing on drugs based on peptides derived from human proteins. Our prime focus is to stimulate hair growth with promising results with our drug candidate FOL-005 in two recently concluded clinical trials. Our diabetes peptides have further demonstrated an ability to increase the released insulin in preclinical models and we have selected a drug candidate. The company was founded in 2011 and listed on the Swedish small cap exchange Spotlight Stock Market (former AktieTorget) in 2014.
Read more: About Follicum
The management of Follicum?
Jonas Edelswärd, Interim CEO & CFO
Read more: Management
The board of directors?
Chairman of the Board: Gun-Britt Fransson
Members of the board: Prof Emeritus Lars H Bruzelius, Alejandra Mørk, Carl-Johan Spak
Read more: Board of Directors
Is Follicum listed on a public exchange?
Follicum AB was listed on the Swedish small cap exchange Spotlight Stock Market (former AktieTorget) in November 2014.
Read more: Share information
The research areas of Follicum?
Hair growth: Our most developed research project is focusing on the stimulation of hair growth for patients with unwanted hair loss (partial or whole baldness). Our drug candidate, the peptide FOL-005, has in 2018 been through a clinical phase I/IIa trial in Berlin/Hamburg with very positive results. In 2020 a second phase II study is performed on scalp with our newly developed topical formuation on male alopecia patients.
Read more: FOL-005 and regulation of hair growth
Diabetes: Our initial research on human proteins has continued and during Spring 2017 we observed a substantial release of insulin from mice pancreas in preclinical trials with a peptide derived from another protein, FOL-014. The basic research is carried out with different research groups at the University of Lund, the location of our founders. Our diabetes project is mainly carried out at the Clinical Research Centre (CRC) at the University Hospital in Malmö – managed by professor Jan Nilsson’s research group. This is mainly due to a large governmental founding on diabetes from the Swedish Foundation of Strategic Research.
In the diabetes project we have selected the most promising drug candidate in an extensive selection process. This candidate will be developed further, primarily in preclinical development with additional studies of safety and effect. Based on the results of the preclinical program, the company will plan to start a clinical phase I trial during 2020. In addition to the selected drug candidate, three ”follow-up” candidates have been selected. Several of our peptides show interesting effects in initial studies, but the peptides have slightly different profiles, addressing different types of diabetes complications. Our ambition is to evaluate this further, in parallel to the preclinical development of the selected drug candidate, not least because potential partners for the project have shown interest in different types of complications.
We work targeted to identify factors that can differentiate us from competitors in diabetes.
Our new peptide class stimulates the release of insulin and the results show clearly its potential to become a valuable complement in the treatment of diabetes. In type 2 diabetes, the body’s ability to gradually produce insulin is deteriorated and for the body it becomes more and more difficult to respond with increased insulin production in a sufficient quantity after, for example, a meal. In addition, the body’s ability to use insulin is impaired, which means that a greater amount of insulin is needed to control blood sugar. Drugs that help improve insulin production or otherwise lower blood sugar levels are already on the market. Nevertheless, many diabetic patients have problems controlling blood sugar levels. Large variations in blood sugar levels are behind a number of different complications that diabetic patients are often affected by, for example, cardiovascular effects, obesity, liver and kidney damage. Thus, when complications occur, other treatments than glucose control drugs alone are needed. We have performed a number of preclinical studies that have shown that Follicum’s peptides have an insulin-releasing effect that is comparable to, or even better than, some existing diabetes treatments. In addition, insulin release is potentiated at elevated glucose concentrations in in vitro experiments, exactly what one wants to achieve for patients with high blood sugar. The potential ofin the peptides has also been confirmed in glucose tolerance tests, where they have a glucose lowering effect in laboratory animals. Experimental studies also show that our new optimized peptides have a protective and conservative effect on beta cells that have been exposed to high concentrations of glucose for a long period.
Read more: FOL-014 Pre-clinical research
How do we commercialise our products?
Our future revenues are planned to come from licensing or sale of parts or whole projects to pharmaceutical and/or financial stakeholders. At the moment we do not see Follicum as a production or marketing organisation in the future. The timing will be essential for each of our development projects and we may seek an exit for a drug candidate even before the clinical phases are finalised.
Our projects in hair growth
What is alopecia or hair loss?
Human hair – both to much or to little – is an important social factor in our society. Millions of people suffer from early hair loss (alopecia) and more millions, often women, suffer from unwanted hair growth (hirsutism). Many times, with psychic traumas because of the hair loss. There are no real efficient and secure treatment available, suitable for both men and women.
Read more: Hair growth
What is hirsutism (unwanted hair growth)?
There are two distinct markets for removal of unwanted hair. First the medical where the hirsutism condition gives women a strong male hair growth. The second is the cosmetic market (non-medical). Each culture in the world has developed social norms for the status of hair growth on the body. The cosmetic reasons for hair removal may range from pure aesthetic to religion based.
Read more: Hirsutism
The mechanisms of FOL-005?
Our latest research has identified receptors in human hair follicle cells that our lead candidate FOL-005 binds to. The newly acquired knowledge paves the way for a better understanding of how FOL-005 can be used for treatment of hair loss, and a significant milestone in the continued development of FOL-005. We continue to explore the MoA and receptors e.g. through the work performed by the Postdoc which was financed by LUDC via the LUCD-IRC consortium in 2019.
Press release Receptors for FOL-005: Important new receptors for Follicum’s lead candidate FOL-005 in hair follicle cells identified
Our continued development of FOL-005?
The company has initiated a clinical phase II study where hair growth stimulating effect of the treatment with FOL-005 on the scalp with a topical formulation is being studied.
Millions of people, more men than women, experience partial or total hair loss. The market for hair loss products is estimated to 7,6 MUSD and the forecast for 2024 is close to 12 MUSD (Report: Grand View Research: Alopecia Treatment Market 2017).
The main substance in many products on the market is minoxidil. Many individuals do not response well to this substance, with side effects as hair loss, headaches and skin irritation.
Thus, there is a large potential for an efficient and safe drug against hair loss for many patients.
Our projects in diabetes
What is diabetes?
Diabetes is a scourge which grows every year and with the main number of patients (90 %) which is caused by unhealthy diet, smoking, alcohol consumption and lack of physical activity; defined as diabetes type 2. A smaller part of the diabetes patients, diabetes type 1, is an inherited condition in younger people. The World Health Organisation, WHO, estimates the number of individuals with diabetes to 420 million world-wide. Within 20 years, the number of patients with diabetes 2 is expected to be doubled. Adding to this is a huge number of un-diagnosed individuals.
Read more: About diabetes
Our diabetes project
Our preclinical research with Professor Anna Hultgårdh Nilsson, at the Centre of Bio Medicine in Lund, BMC, and Professor Jan Nilsson at the Clinical Research Centre at the University of Lund, CRC, have resulted in several new peptides and one drug candidate. These peptides have shown to bind in the pancreas, creating an increased release of insulin from the pancreas in mice. Further preclinical trials will be performed to investigate the positive effects of our peptides.
Read more: FOL-014: Pre-clinical research
Diabetes market estimates?
The market for treatment of diabetes type 2 is divided in different sub-groups with annual sales of more than 60 BUSD. The major products are DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors as well as different versions of insulin treatment.
Read more: About diabetes
Our continued development?
Further preclinical trials in diabetes will be conducted to investigate further effects of our diabetes peptides. See above ”Our diabetes project”.