Follicum approaches Phase II study with proDERM
Biotech company Follicum will conduct its upcoming Phase II study in hair loss together with the German CRO proDERM. The Charité Universitätsmedizin Berlin had previously been confirmed as a partner for the study, which is expected to start just after the turn of the year. BioStock met with Follicum’s CBO Gunnar Gårdemyr, at BIO-Europe in Hamburg, who told us more about their new German partner.
Peptide specialist company Follicum has entered a collaboration with the German contract research organization (CRO) proDERM for the upcoming Phase II study with its main candidate FOL-005.
Recognized hair-specilist CRO
proDERM is a top international CRO based in Hamburg. This new partner to Swedish Follicum specialises in clinical studies in disorders related to not only hair, but also to skin, mucous membranes, eyes and mouth. This makes proDERM an optimal partnering choice for Follicum, whose upcoming Phase II study will evaluate the topical formulation of FOL-005 in alopecia patients – i.e. patients suffering from hair loss. The study will assess the candidate’s hair growth-stimulating effect with different strengths of the new topical formulation – an easy-to-use cream that is lubricated into the scalp.
The Phase II study follows two previous clinical studies with FOL-005 that demonstrated a good safety profile and indicated hair growth-stimulating effects. Preparations for the next step in its clinical development, with the objective to demonstrate Proof-of-Concept, are currently ongoing and Follicum aims to start the study in the beginning of 2020.
The agreement entered with proDERM warrants a proper execution of the study as the CRO fullfils the conditions and high-quality standards the authorities have set for conducting clinical trials.
The CEO signals high confidence
In a press release, Follicum’s CEO Jan Alenfall commented on the collaboration agreement:
– Preparations for the clinical trial are in full swing and we are very pleased to have signed an agreement with proDERM, thus representing an important milestone for conducting the new study on alopecia patients. proDERM is a highly qualified partner with extensive experience in hair studies. The upcoming clinical study will, in accordance with previous plans, be carried out at two clinics, in part at Charité University Hospital with which Follicum has conducted previous collaborative clinical studies and at proDERM. Both clinics have broad expertise and extensive experience from performing hair studies. We intend to submit the application for starting the Phase IIa study with the new formulation to the German Federal Institute for Drugs and Medical Devices (BfArM) in November.
BioStock met Follicum at BIO-Europe
When news came of Follicum’s collaboration agreement with proDERM, BioStock was in Hamburg – proDERM’s hometown – to participate in the largest partnering event in Europe, BIO-Europe. In the middle of the conference’s energetic network landscape, we bumped into Follicum’s Chief Business Officer, Gunnar Gårdemyr, and took the opportunity to ask him a few questions about the agreement.
Are you at BIO-Europe in Hamburg to sign the agreement with proDERM?
– I had planned to participate in BIO-Europe for a long time. The fact that it coincided with signing the agreement was just a happy coincidence, and not something that we planned.
»We are very impressed by proDERMs expertise in conducting clinical trials and by their experience in hair studies. Therefore, we are very pleased to have signed the collaboration agreement, which will ensure that the project is advanced efficiently and with high quality.« – Gunnar Gårdemyr, CBO at Follicum
Is proDERM a new acquaintance or have you had ongoing discussions?
– This is the first time we will work with proDERM, but we have had a very rewarding dialogue with them during the past six months, where we have discussed the FOL-005 project as well as the upcoming study. All in all, we are very impressed by their expertise in conducting clinical trials and by their experience in hair studies. Therefore, we are very pleased to have signed the collaboration agreement, which will ensure that the project is advanced efficiently and with high quality.
How significant is proDERM’s previous experiences with hair studies?
– It’s extremely important. Hair, hair growth and hair disorders are complex processes and it is important to have a comprehensive knowledge and understanding of hair biology to be able to design an optimal clinical program. proDERM has conducted many clinical studies in the hair and skin area and this experience is of great benefit in light of Follicum’s new phase II study, where we will test the cream-like formulation of FOL-005.
What does the collaboration mean for the planned phase II study?
– The fact that we started the collaboration with both proDERM and Charité, which are the two clinics where the study will be carried out, means that we are following our set timelines. At both proDERM and Charité, we are in contact with field-specific experts and well-known Key Opinion Leaders who can provide valuable input on study design, patient recruitment, analysis methods, etc. This is tremendously reassuring for the large commitment that a phase II trial entails for a small biotech company.
What additional milestones, besides getting the study application approved by BfArM, remains before you can start the Phase IIa study?
– All critical activities have started, but not all parts are ready yet, which is entirely according to our communicated timeline. For example, we have carried out the manufacturing of a new batch of the active substance, that is, of very high-quality FOL-005. Production of the clinical trial material, i.e. the cream itself, has also begun but all the steps and all the strengths are not ready yet. This should be completed before the end of the year.
– The next milestone is that we should submit the application to the German authorities to carry out the study. The application requires extensive documentation of the project, which we have put together during the fall. We thus expect to be able to submit the application within the next few weeks.
»I have met with twenty-something companies from the US, Europe, Japan, China and Korea – all active in the hair, dermatology or cosmetics area. Many of these companies express great interest in FOL-005 and look forward to the results of our POC study.«
You always intended to conduct the study in Germany, which will now be the case. Why Germany?
– The extent of expertise and knowledge of hair and hair diseases found in Germany is difficult to find in other countries. Furthermore, we have other collaborations with German groups, not only for clinical trials but also, for example, preclinical models of alopecia. It is due to this accumulated knowledge in the hair field that we conducted our two previous clinical studies in Germany. The University Hospital Charité was involved in both of these previous studies and they will also be active in the new study, which guarantees a continuity that is very important for Follicum and our hair project.
Apart from signing the collaboration agreement, have you had any other interesting meetings at BIO-Europe?
– I have met with twenty-something companies from the US, Europe, Japan, China and Korea – all active in the hair, dermatology or cosmetics area. Many of these companies express great interest in FOL-005 and look forward to the results of our POC study. I have also let the companies see and try a placebo version of our new cream-like formulation, which has been greatly appreciated. I have received many positive comments about the formulation, which is perceived as easily absorbed with a pleasant feeling on the skin.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
