Follicum successfully completes its Phase I / IIa clinical study of FOL-005 and prepares for a Phase II clinical study

August 2, 2017

Follicum successfully completes its Phase I / IIa clinical study of FOL-005 and prepares for a Phase II clinical study

Follicum AB (“Follicum”) has now obtained the final results from the completed phase I / IIa clinical study. The results after a three-month follow-up period following the completion of treatment with FOL-005, demonstrate that the rate of hair growth does return to its original level. The results thereby confirm that Follicum’s drug candidate FOL-005 stimulates hair growth during the treatment period.

In January 2016, Follicum initiated a phase I / IIa clinical study at the Clinical Research Center for Hair and Skin Science (“CRC”) at the Charité University Hospital Berlin, in Germany. The study aimed primarily to evaluate the safety profile of the company’s drug candidate FOL-005 and secondarily, to evaluate parameters regarding its efficacy. In February 2017, Follicum was able to announce that FOL-005 was well tolerated, and in April 2017, FOL-005 was reported to stimulate hair growth with a statistically assured increase of approximately 8% compared with a pre-treatment rate of growth. The extent of this hair growth stimulation being similar to that described for preparations currently on the market.

The three-month follow-up is now completed
Now, three months after the final treatment of the study participants with FOL-005, a safety and efficacy follow-up assessment has been performed and the whole study is therefore completed. During this follow-up period, no treatment with FOL-005 has occurred. The results show a very good safety profile. Approximately 2% of the increase in hair growth remains after the three month period without any additional treatment, compared with an increase of approximately 8% immediately after completion of treatment with FOL-005. This confirms that Follicum’s drug candidate FOL-005 is well tolerated and that the effect of treatment is the stimulation of hair growth.

In the completed Phase I / IIa study, FOL-005 was injected into the front of the thighs. Despite this, Follicum’s substance has demonstrated efficacy results that are in line with the published Phase III studies of existing preparations on the market. The fact that FOL-005, in its first clinical trial is able to demonstrate a statistically-assured effect on hair growth, without the study being primarily designed for this purpose is very interesting.

Preparations for a study on the scalp
The next step in the development of the drug candidate FOL-005 is to perform a study similar to the recently completed study, but on the scalp, which is the intended area of use for the final FOL-005 preparation. The ambition being to further clarify the effect of FOL-005. In parallel, the development of a user-friendly formulation will proceed according to current plans. Once an optimized formulation has been developed, the company intends to initiate a more comprehensive study of the efficacy of FOL-005 on the scalp.

CEO Jan Alenfall comments
– We are pleased to be able to present the final report of the three-month follow-up after the phase I / IIa clinical study, which, over the months of treatment of the study subjects, has demonstrated that FOL-005 is well tolerated and has a positive effect. The final results showing that only a part of the hair-stimulatory effect remained once the study participants were no longer receiving treatment, were expected. Overall, the clinical study has shown that treatment with FOL-005 is safe and appears to have a good effect, despite the fact that the final formulation and final dosage are not yet finalized. All in all, these results provide us with a good basis to warrant the continued development of FOL-005 at the next stage of product development.

For further information, please contact:
Jan Alenfall – CEO, Follicum AB
Telephone: +46 (0)46 – 19 21 97

Mikael Theander, Communications & PR
Telephone: +46 (0)764-263542

This information is information that Follicum is obliged to make public according to the EU Market Abuse Regulation. The information was provided through the agency of the contact persons above, for publication on the 31st of July, 2017.

About Follicum
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.