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BioStock published an article on 30 September 2019 about Follicum, which can be read in full below.

Follicum’s business strategy is to enter into a partnership, out license or sell their candidates following phase II trials at the latest. With proof-of-concept and top-line-data for FOL-005 firmly within reach during 2020, the company is getting closer and closer to realising its business model.

Follicum develops pharmaceutical drugs with First-in-Class potential, i.e., completely new treatment concepts with unique mechanisms of action within the field of stimulation of hair growth and diabetes. These are both areas with large, unmet medical needs.

The company’s main candidate FOL-005 is a modified short version of the endogenous protein osteopontin. Two clinical studies have shown that FOL-005 is an effective and safe treatment for hair loss (alopecia), a disease that carries a heavy stigma and accounts for more than 95 per cent of hair loss in men.

At age 35, two thirds of men experience noticeable hair loss, and at age 50 the equivalent number is circa 85 per cent. For about 25 per cent of men suffering from hair loss, the hair loss process starts already in their twenties. When it comes to the numbers for women, about 40 per cent suffer from hair loss at some point during their lives.

There is ongoing planning for a phase IIa study with the aim of investigating the hair growth stimulating effect after treatment with varying strengths of the new topical formulation of FOL-005. This new formulation is in the form of an easy-to-use cream that the patients can apply at home and that will be manufactured by Malmö-based Bioglan.

The market for alopecia products

Increased consumption of tobacco and alcohol, higher stress levels, and an ageing population are a few of the reasons for the global alopecia market being expected to reach a value of 12.99 BUSD during 2026. Other contributing factors are an increased incidence of chronic disorders such as hyperthyroidism (Graves’ disease and goitre), hypothyroidism (underactive thyroid) and diseases such as Hodgkin’s disease, Hashimoto’s disease, Addison’s disease and coeliac disease.

FOL-005 background

In March 2015, as preparation for upcoming clinical studies was underway, Follicum initiated two extensive toxicology studies as an extension and continuation of two shorter toxicology studies that had finished with positive results a month earlier. Before the year was over the company had also conducted two extensive toxicology studies with, in the company’s own words, very positive results.

The results showed that FOL-005 does not cause any negative effects or harm at the administration (injections) sites after three months of daily treatment with the highest dose. The study outcome was an important milestone in terms of the regulatory aspect as longer term treatment is needed to affect hair growth.

With the toxicology studies in the bag, the company stood on solid scientific ground prior to upcoming clinical studies. As we will see further on, the plan was already from the beginning to create a more user-friendly product.

Much has happened since then and during the past four years Follicum has continued to release news with no research or business disappointments.

Crucial steps await

Skipping ahead to 2019, we can note that Follicum today, based on interesting clinical data, are about to enter some crucial steps. The company has certainly enhanced the chances of obtaining good data by adding diabetes to the pipeline thereby spreading the R&D risks. Read more about how Follicum entered the diabetes arena and their achievements in this field, here.

However, FOL-005 for hair loss remains Follicum’s main project. Below we have chosen to highlight some of Follicum’s more important advances in the diabetes project made during 2019.

Treatment at home

It has never been Follicum’s intention that the injections be the final, commercial product. The plan all along has been to develop a topical formulation. A huge step in this direction was taken in 2018 when a topical formulation was chosen: an easy-to-use cream applied to the scalp and that, in an animal study, has been found to offer good hair stimulating effects.

Next, the formulation will be tested in a clinical phase IIa study in alopecia patients. The new formulation makes it possible to easily study several doses and increase the dosing frequency as the individual patient is to manage the treatment at home every day. This simplifies the study and also means that the number of visits to the clinic during the study is minimised.

Positive response from German authorities

In June 2019, a successful meeting between Follicum and the German medical authority BfArM concerning the company’s plans for the upcoming clinical study with FOL-005. The authorities require an additional study when the mode of administration changes, e.g., when changing from injections to a topically-applied cream. Among other things this means that the company needs to determine that the topical formulation does not cause local reactions when applied to the skin.

A financial reignition

Follicum can advance towards phase IIa on solid financial ground. On July 4, the company finished two parallel rights issues totalling 56 MSEK. The two issues were fully subscribed making it possible for the company to enter into strategic deals for its two peptide-based drug projects, in hair loss and diabetes. With the financial needs met, the company can now focus on the clinical study.

New patent approval expected shortly

On September 17, the company found out that the American patent authority USPTO had granted them a preliminary approval (Notice of Allowance) for their American patent application. When the approval is finalised, it will expand the protection of FOL-005 and be valid until 2032. USPTO’s decision was one step in the company’s global patent strategy and opens up for new commercialisation possibilities on one of the largest markets for Follicum.

In April 2019, Follicum also applied for a patent for the new FOL-005topical formulation. Such a patent would, if approved, extend the intellectual property rights by eight years, meaning they will last until 2040. This would add significant value to the project through the extended commercial exclusivity that this would entail. This is important, not least in future negotiations with potential buyers of the project.

Manufacturer of FOL-005 appointed

On 26th September, Follicum signed a collaboration with pharmaceutical company Bioglan concerning the production of clinical trial material of Follicum’s new cream-like formulation of FOL-005 for topical treatment. The formulation will be used in the clinical phase II study of hair loss expected to start in early 2020. The product is a cosmetically attractive, cream-like formulation for topical treatment.

CEO Jan Alenfall commented the collaboration:

»Preparation work for the new clinical study with FOL-005 is in full swing and we have now also established a collaboration with Bioglan, a company we have great confidence in. The company is reputable, it manufactures products for a large number of pharmaceutical companies and has a solid track record. Delivery of the finished, cream-like product is expected to take place well in advance of the start of the clinical trial early next year.«  

Partnering possibilities and plans

If Follicum continues to spoil the market by rigorously keeping to their time plans, clinical studies will commence in early 2020. A positive study outcome would establish Proof-of-Concept, i.e. that the concept of the new topical formulation actually works in practice – a powerful message to the market.

However, we cannot expect any prior hint about the study outcome as the study is double-blind, which means that no interim data can be communicated until the study code is broken and data has undergone final analysis, all in accordance with common practice.

Follicum nearing countdown

The company hopes to deliver top-line data during autumn 2020. Provided that the study achieves its goals, i.e., that effect and safety of FOL-005 in the cream-like product are confirmed, the company will initiate a more intense period of negotiation. This will be done to adhere to the company’s stated ambition that following clinical phase IIa, at the latest, it will enter into a partnership with an international pharmaceutical company, sign an out licensing deal or sell the entire project. Thus, we can expect one or more deals in this scenario during the period 2021 to 2022.

The business plan for the diabetes project is similar but here Follicum is open to deals already in the late preclinical stages. It cannot be excluded that Follicum, alongside the efforts to exit, will also add further areas of use for their peptides or through their topical formulation. The company has hinted as much on several occasions.

Follicum satisfies the requirements

In phase I the drug’s safety is tested in healthy human volunteers. A phase I study also looks at how the drug is broken down in the body and the effects of the drug. As the effect in humans is unknown, only a small dose is given. Phase II, which comprises a larger population of study subjects suffering from the specific disease, investigates how effectively the drug treats the disease and which dose is appropriate for use in subsequent phase III studies. So, the aim of phase II is to show that the drug actually has an effect in humans. On the road to this point, the company has been able to reach many milestones.

Also read: Kan Follicums peptider bli ett vinnarrecept mot diabetes? (2 Sept. 2019, in Swedish)

See an interview with CEO Jan Alenfall at Nordic Life Sciences Days (13 Sept. 2019)

Read the article at BioStock's webpage