Follicum AB hereby announces that the FOL-005 study at the Charité hospital in Berlin, Germany, has shown a stimulation of hair growth in treatment of healthy volunteers. In February 2017, Follicum is able to announce that the company’s phase I/IIa clinical study of the FOL-005 candidate drug showed a good safety profile, and that no negative effects of the treatment were found.
– The results from Berlin are very pleasing since the data from this limited number of individuals demonstrate a stimulation of hair growth, with an approximately 8% increase compared with growth before treatment, and at the dose closest to that which gave the best effect in our pre-clinical studies, says Jan Alenfall, CEO at Follicum.
Results show an increase in hair growth
The results from Follicum’s phase I/IIa clinical study, which was performed on healthy volunteers, show a general stimulation of hair growth with an increase which is statistically assured at around 8% compared with growth before treatment (p=0,0038, not adjusted for multiplicity). Data from the study also show that the dose, given three times per week gives more evident effect than twice per week, which implies that a more frequent administration than was used in the study could increase the effect further. The equivalent effect for placebo is a 2% decrease in hair growth (p=0,4613). The study shows that, as expected, there is a wide variation in response. Despite that the recently completed study is limited by the fact that FOL-005 has been injected into the front of the thighs, the results of the study on Follicum’s substance are in line with previously published in phase III-studies on existing marketed drugs. It is important to note that the study was not primarily designed to study the effect of the substance. The fact that the first clinical study performed on FOL-005 showed significant effect is very interesting and may mean that the duration of the development program can be shortened. Among other things, since dosing in further clinical studies is not expected to reveal any side-effects, it could potentially lead to a faster recruitment process.
– It is exciting to see that we can show a good effect despite that we have not yet developed a final formulation nor have finalized the dosage. In published studies on existing products it has been reported that an increase in the thickness of the hair in an order of magnitude of 4-14% after daily, or in some cases, twice daily, treatment. The result in our study shows an average increase of 8%, a difference which is also statistically assured compared to growth before the treatment. We assess that it is likely that the effect we have seen in our study can be further improved with continuous dosing and with a new formulation, CEO Jan Alenfall continues.
The study tested four different doses. The lowest dose exhibited a weak effect, the second dose showed the best effect and of the two highest dosages, dose three had some effect while dose four did not exhibit any effect at all. Such different responses are not uncommon (and is called a bell-shaped dose/response). The variation between data is large which can be expected in a study at this early stage of development and with the limited number of volunteers included in the phase I/IIa clinical study. Follicum is now awaiting data from the follow-up period which continues for three months after completion of treatment.
The market for a hair growth stimulation drug
Unwanted hair loss (alopecia), which is commonly referred to as “baldness”, affects a third of all men between 20 and 50 in the west. For men over 50, the proportion of men with hair loss is even higher, around 50%. Taken together this indicates that there is an extensive market for an effective and safe hair-stimulating medication. Existing products on the market are for instance Rogaine and Propecia. The market for these two products alone are estimated to be around 3 billion USD annually*. Compared to existing drugs, we expect that the Follicum product will offer additional advantages – such as fewer side-effects – which would imply good potential for the company.
In conclusion, Follicum’s newly completed phase I/IIa clinical study has given the company good preconditions to motivate the continued development of FOL-005 and to initiate further clinical studies as soon as possible.
– We look forward to the continuation of the development towards a phase two study with a more user-friendly formulation to optimize dosage and treatment times. Our focus now is to create the best formulation of our substance. We already have a number of parallel tracks ongoing, which will determine whether it will become an ointment, cream, gel or even FOL-005 in the form of nanoparticles. As soon as we have the right formulation, the goal will be to initiate a thorough efficacy study of the scalp; a so-called phase two study, where we would expect further clarity on the effect and where we hope to confirm and to improve on the results which the current completed clinical study has shown, concludes CEO Jan Alenfall.
* Global Data: Alopecia Therapeutics – Pipeline Assessment and Market Forecasts to 2017
For further information, please contact:
Jan Alenfall – CEO, Follicum AB
Telephone: +46 (0)46 19 21 97
Mikael Theander, Communications & PR
Telephone: +46 (0)764 26 35 42
About Follicum AB
Follicum was founded in 2011 by two researchers in Lund, Anna Hultgårdh and Pontus Dunér, based on research around a human protein, osteopontin. Among other things, this protein is considered to be involved in the growth of bone tissue. Follicum isolated a part of this protein and partially modified partly its amino acid sequence, which generated Follicum’s drug candidate FOL-005. In early studies, FOL-005 showed an ability to both stimulate and inhibit hair growth. During 2016/2017, the company conducted its first clinical phase I/IIa study. Follicum is based in Lund and was listed on AktieTorget in 2014.