BioStock published an article about Follicum’s topical formulation on 7 February 2019 in Swedish. The article is here translated into English.
Follicum develops FOL-005 to stimulate hair growth. The peptide-based candidate has recently undergone a phase IIa-study and the company was able to present positive top-line results during the fall. This summer a topical formulation of FOL-005 was completed and the company have now presented results demonstrating that treatment with the new formulation stimulates hair growth in an in vivo-study. BioStock have spoken to Maria Ekblad, R&D director at Follicum, to find out more.
In all previous studies, FOL-005 has shown a beneficial effect – and safety profile. In the recently completed phase IIa-trial, which studied safety and effect in patients with hair loss, intradermal injections to the scalp was used. Therefore, all doses of FOL-005 were administered at a hospital, which means that it has been possible to ensure that all dosing was carried out correctly. This also enabled detection of any side effects. However, no side effects related to FOL-005 were observed in any of the studies that have been carried out.
Crucial that the patient can administer the product
From the get-go Follicum have been aware that a product that requires visits to a healthcare facility is not commercially viable. For this reason, Follicum have, alongside the clinical development of the candidate, worked on a topical formulation – i.e. a creamlike formulation that can be applied directly to the scalp whilst efficiently delivering the active compound to the skin and follicles.
In June, the company announced that they had developed and chosen a topical formulation with a cosmetically appealing and user-friendly profile. In an interview with BioStock, CEO Jan Alenfall talked about the importance of the topical formulation to Follicum and the candidate’s future prospects.
”The formulation we have now chosen has proved to live up to our expectations in an excellent manner.” – Maria Ekblad, R&D director at Follicum
In connection with the announcement that a topical formulation had been chosen, the company did not want to comment on the type of formulation. But now Follicum can reveal that they have obtained good in vivo results from the creamlike product.
To find out more about the process, what the final formulation is and what happens next, BioStock have spoken to Follicum’s R&D director, Maria Ekblad.
Can you expand on how important it is to have a topical formulation of FOL-005?
– For the indication Alopecia, i.e. hair loss, we consider it is a huge advantage to have a formulation that the patients can administer themselves.
– The product we have developed is intended to be easy to use by the patient at home so that the patient isn’t tied down to hospital visits. This means a significantly improved quality of life in many ways, not least in terms of practicalities, but also e.g. financially for both the patient and the healthcare system.
– The application will only take a few minutes and it is easy to bring the product with you when you travel so that breaks in the treatment can be avoided.
”The positive results from the in vivo study are very important as they provided clear evidence that the treatment with the new formulation really works and leads to a clear stimulation of hair growth.”
You evaluated several alternatives for topical formulation. Can you tell us something about the process for finding the optimal formulation?
– Even before we began the development of the formulation, we were aware that it is very difficult to formulate peptides. We have now developed a very good formulation which is very satisfying.
– To quickly identify a promising way forward, we chose to simultaneously test several different technologies. We tried producing creams in the traditional way, but we also thought outside the box. Early on it became obvious that the traditional way didn’t work and that a new approach was necessary.
– From there we continued the development with three options and from an industrial development perspective – they have all shown promise. The formulation we have now chosen has proved to live up to our expectations in an excellent manner.
– Throughout the process we have chosen to work with extremely knowledgeable and innovative contract research companies whose dedicated work as helped us develop the final creamlike product.
You have recently announced positive date from an in vivo study with the new formulation. What does this mean?
– The positive results from the in vivo study are very important as they provided clear evidence that the treatment with the new formulation actually works and leads to a clear stimulation of hair growth.
– The study also compared FOL-005 to an established treatment, Minoxidil 5%, and for the majority of the study the results were equal. Based on the results we also draw the conclusion that we have not obtained maximum effect with the current dosage of FOL-005. Thus, dosage and application frequency will be optimised in the clinical study that we are now preparing.
”As it’s a new formulation and a new way of administering the rules for drug development demand that we supplement […] with a new toxicology study in order to ensure that no local reactions occur in connection with application to the skin. We are counting on being able to commence this during spring. In addition, the formulation should be produced in greater quantity […]. Our plan is to largely complete these activities before summer, so that we can begin the topical clinical study during the latter part of 2019.”
The new formulation of FOL-005 requires a confirmatory phase II study. When do you expect to commence such a study and what preparations are needed?
– As it’s a new formulation and a new way of administering, the drug development regulations demand that we supplement the completed toxicology-programme with an additional toxicology study to ensure that no local reactions occur in connection with application to the skin. We are counting on being able to commence this during spring.
– In addition to this, the formulation should be produced in greater quantity and we need to find a suitable company to carry out the study. Our plan is to largely complete these activities before summer, so that we can begin the topical clinical study during the latter part of 2019.
The topical formulation means that the patients can administer FOL-005 themselves. How will you make sure that administration is done in accordance with your recommendations, thus ensuring optimal treatment outcome, in the upcoming trials?
– There is always a sense of security when the administration takes place at a clinic; this has been the case with our two previous clinical studies. When the patients administer the treatment themselves greater variations will occur, and this will have to be taken into account when planning the study.
– The trial will have to include a greater number of patients and it is important to be fastidious when it comes to instructing patients and health care staff prior to treatment initiation. The dosage as well as the handling of the product will be described in detail to both staff and patients. These things will also be demonstrated visually before and during the trial.
You have previously mentioned that it would be interesting to have a longer treatment and follow-up period for treatment with FOL-005 in order to utilise its full potential. Will the confirmatory phase II study have a longer treatment period than the 3 months used in the recently completed phase IIa-study?
– Hair growth is quite a lengthy process. In order for a dormant follicle to become active and produce new hair, the first things that needs to happen is activation of dormant cells, a large part of the follicle needs to grow and then a new hair needs to be produced. So, 3 months is a relatively short period of time for a clinical study of hair growth. A longer treatment time would be beneficial and could result in a greater increase in hair growth.
– In our first study, we treated the healthy volunteers for 3 months and managed to show significantly improved hair growth. In the second study we could also see that the hair growth was stimulated. The results were clear in showing that significantly fewer follicles were dormant in the group treated with FOL-005 compared to the control group. This indicates that a longer treatment period might be able to further increase hair growth.
– As part of the planning for the next clinical study we will shortly discuss the study design with the German Medicines Agency.
You have previously also stated that your intention is to sign a partnership deal after the phase II study with the topical formulation is completed. The reason to wait for the trial data being that it will optimise the value of your product in coming negotiations. In which way would you say that this increase the value?
– Our assessment is that the interest for a topical product is much greater among the users, and therefore the market, compared to an injectable formulation. The possible partners that we are currently in discussions with, have also made it clear that they consider study results from a clinical topical study as ”proof of concept” for the FOL-005 project.
”We are planning for a scientific meeting with the German Medicines Agency to discuss the approach and design of the upcoming topical clinical study. Until we have had that meeting, we cannot calculate the study cost as a whole.”
So, the plan is to conduct the confirmatory phase II study on your own. What do you expect this study to cost and is the expected cost accommodated for by existing capital?
– It is very expensive to carry out a clinical study. How expensive the studies are depends on the study design and the number of patients included. So, we are planning for a scientific meeting with the German Medicines Agency to discuss the approach and design of the upcoming topical clinical study. Until we have had that meeting, we cannot calculate the study cost as a whole.
What other milestones can we look forward to from Follicum during the coming year?
– For the hair project, the next major milestone, is the start of a the clinical trial in which alopecia patients will be treated with the topical formulation. Prior to that we will begin production of larger quantities of the formulation.
– In addition, we are counting on choose a candidate from the new peptides developed in the diabetes project in the first quarter. This is also a very important milestone. Several of the experimental studies we are conducting within the diabetes project are central to the company, and those results are all important milestones.