Plans
Strong patent protection beyond 2040
Follicum has a strong foundation of patents providing solid market protection until 2040. There are two key patents: firstly, the composition of matter of FOL005 and its use to stimulate hair growth (WO2013021212) which is granted in all major markets and secondly, the unique topical formulation of FOL005 enabling the peptide to penetrate the skin (PCT/EP2020/061453).
In addition, a priority application has been submitted for the use of FOL005 in wound healing in May 2022. All patents are submitted in major markets including the US, Europe, Canada, Australia, Japan, China and India.
Next steps – costs, partnering and out-licensing
Roadmap until 2025
The primary objective of Follicum will be to develop FOL005 for the treatment of hair loss and secondarily to develop FOL005 for the treatment of diabetic wounds. The planning of clinical trials is ongoing and depending on design of these studies and appropriate funding, we currently predict the following key milestones until the end of 2025:
Hair loss (andro-genetic alopecia) – preliminary milestones
2H 2023: Finalization of pre-clinical 9 months tolerability testing
2H 2023: Key partners identified for funding and development of FOL005
1H 2024: First patient in phase IIb study (FCS-004) in hair loss.
2H 2025: Key results of phase IIb FCS-004
2H 2025: Scientific Advice meetings to prepare phase III pivotal program
Wound healing – preliminary milestones
1H 2024: First patient in phase II study (FCS-004) in hair loss.
1H 2025: Key results of phase II FCS-004
Clinical cost
The goal is to identify a license or co-development partner for financing the clinical trials with FOL005 in hair loss and in wound healing. Depending on the number of study patients and length of study, we estimate the following clinical cost:
Pre-clinical
Total cost for the pre-clinical tolerability studies: 6-9 mSEK.
Phase IIb clinical trial – hair loss
Total cost of implementation and completion of the phase IIb study: 50-70 mSEK.
Phase IIa clinical trial wound healing
Total cost of implementation and completion of phase IIa study: 20-25 mSEK
Exit strategy
We believe there is a high likelihood of success based on the previous clinical data. The next phase IIb will strongly increase the value of FOL005 and our strategy is to identify a license or co-development partner to share the risk of further development. Our goal is to make a license co-development agreement before initiating the phase IIb clinical trial in hair loss.