10 April 2017
Follicums clinical study showed stimulation of hair growth
Open press release
Follicum AB ( "Follicum") is pleased to announce that the FOL - 005 in the study at the Charité Hospital in Berlin, Germany, demonstrated a stimulation of hair growth in the treatment of healthy volunteers. Follicum could already be in February 2017 to announce that the Company's clinical phase I / IIa study demonstrated a good safety of the drug candidate FOL-005 and no adverse effects of the treatment have been found.
- The results from Berlin are very pleased when our data in the limited number of individuals shows the stimulation of hair growth, approximately 8% increase compared to before treatment, at the of the doses that are closest to the dose that produced the best effects in our preclinical studies , says Jan Alenfall, CEO of Follicum.
Results show the increase in hair growth
results from Follicums clinical phase I / II trial conducted on healthy volunteers, showing a whole that hair growth is stimulated by an increase is statistically significant (p = 0.0038, not multiplicitetsjusterat) of about 8 % compared to before treatment. Data from the study further shows that dosing three times per week for clearer effect than twice weekly, suggesting that a more frequent administration than that used in the study can provide further better effect. The corresponding effect of placebo is a decrease of 2% in hair growth (p = 0.4613). The study shows that there is considerable variation in the response, which was expected. Although the recent study is a limited study, which FOL-005 has been injected in the front of the thighs, shows Follicums substance, however, the efficacy results that are in line with what is published in the Phase III trials of existing drugs on the market. Important to note is that the study was not primarily designed to study efficacy. The FOL-005 in the first clinical study still showed significant effects are very interesting and could mean a shortened time for development. This is partly due to the doses in future clinical studies should not give any side effects, which could potentially lead to faster recruitment.
- It is exciting to see that we have a good effect, even though we have not developed a final formulation and not have a finished dosage. In published studies on existing products reported an increase in hair density in the range of 4-14% for daily or sometimes twice daily treatment. The results of our study show an average increase of 8%, a difference that is also statistically significant compared to before treatment. We believe it is likely that the effect we see in our study can be further improved with more continuous dosing with a new formulation, continues CEO Jan Alenfall.
The study tested four different doses - the lowest dose showed a weak effect, two dose showed the best effect and the two highest doses had three dose specific effect while four dose showed no effect. Such a differential response is not unusual (and called for the bell-shaped dose / response). The variation among the data is great which is to be expected of a study in this early stage of development and the limited number of subjects included in the clinical phase I / II study. Follicum now awaiting data from the monitoring period which are for three months after treatment.
Marketplace for preparations for stimulating hair growth
Unwanted hair loss (alopecia), commonly referred to as "pattern baldness" affects one third of all men between 20 and 50 years in the Western world. For men over 50 years, the percentage of hair loss is even higher, about 50%. Overall, a very extensive market for an effective and safe hair stimulating drugs. Existing products on the market, for example, Rogaine and Propecia. Only the market for these drugs is estimated at about 3 billion USD annually (1). Compared to existing drugs can Follicum probably offer other benefits- such as fewer side effects - which indicates good prospects for Follicum.
Past performance of the candidate drug FOL-005
Follicums drug candidate FOL-005 showed significant stimulation of hair growth in mouse experiments. In subsequent experiments on human skin - partly in test tubes and partly grafted on mice - showed FOL-005, however, inhibition of hair growth. In light of these results is varying preclinical phase I / II study is very important. The company is now awaiting data from the three-month follow-up in order to gain a more thorough understanding of the effect. Final report of the clinical phase I / II trial is expected to occur after the summer 2017.
In summary, Follicums recent clinical phase I / IIa trial has given the company well positioned to continue the development of FOL-005 and to quickly launch additional clinical studies.
- We look forward to continuing the development work for a Phase II trial with a more user-friendly formulation to optimize, dosage and duration. Our focus now is to create the best formulation of our preparations. We already have a number of parallel tracks at once that will determine whether there will be an ointment, cream, gel or even FOL-005 in the form of nanoparticles. As soon as we have a good formulation, the goal is to launch a more comprehensive impact study on the scalp, called a Phase II clinical trial, which we expect to gain further clarity in effect and where the hope is to confirm and improve the results of the completed clinical study gave concludes CEO Jan Alenfall.
(1) Global Data: Alopecia Therapeutics - Pipeline Assessment and Market Forecasts to 2017
For further information, please contact:
Jan Alenfall - CEO, Follicum AB
Phone 046 - 19:21 97
E-mail:
info@follicum.com
Mikael Theander, Communications & PR
Phone: 0764-263542
Email:
info@follicum.com
This information is information which Follicum is required to disclose under the EU Market Abuse Regulation. The information was provided by the above contact person's Secretariat, for publication on April 10, 2017.
If Follicum AB
Follicum was founded in 2011 by two researchers in Lund, Anna Hultgårdh and Pontus Dunér, based on research on a human protein , osteopontin. This protein is considered among other things, be involved in the growth of bone tissue. Follicum isolated part of this protein and modified partially aminosyrorsekvensen which generearde Follicums drug candidate FOL-005th In early attempts proved FOL-005 both to stimulate and inhibit hair growth. Company completed its first clinical phase I / II study in 2016/2017. Follicum is based in Lund, Sweden and listed on AktieTorget 2014.
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