BioStock article: Follicum takes a step closer to phase III entering 2021

December 17, 2020

BioStock article: Follicum takes a step closer to phase III entering 2021

BioStock published an article on 17 December 2020 about Follicum, which can be read in full below.

A productive 2020 for Follicum is capped off by the completion of patient recruitment for its phase II hair growth study for determining the best dose and treatment duration of candidate FOL-005. BioStock spoke with Follicum’s CEO Jan Alenfall to get his impressions on the company’s highlights for 2020 and what to expect in 2021.

Lund-based Follicum, which develops innovative peptide-based drugs in two distinct indications, hair loss (alopecia) and diabetes, has taken several key steps during 2020 to advance both projects.

Well set-up for diabetes project
The company’s youngest project involves developing a new treatment for diabetes patients. After selecting a drug candidate ­early last year, at the beginning of this year, Follicum received a 1.5-year Vinnova grant to carry out preclinical studies testing the binding capabilities of its peptides to pancreatic cell receptors.

Follicum is the coordinator of the project, which also involves one of the top diabetes research institutions in the Nordics, Lund University, and protein characterisation experts, SARomics Biostructures. Parts of the project also include advanced analyses at the world-leading research facility MAX IV in Lund.

Two major patents awarded
follicum_logo-03In March, an Intention to Grant for a patent application regarding Follicum’s diabetes candidate was obtained from the European Patent Office. The patent will be valid until 4 May 2038 and further increase the value of Follicum’s diabetes project. Then, in June, the company received another patent notice for this project, this time from the US Patent Office. The notice covers the protection of the company’s peptide classes and their use in the treatment of diabetes and diabetes-related complications. The US patent will, as the European equivalent, be valid until 2038.

While both patent notices are important for Follicum’s path forward with the diabetes project, the US patent lays the groundwork for commercialisation opportunities in the US, one of the largest markets for diabetes medicines.

Strong progress with Hair loss project
Follicum’s hair loss project also made headway this year after having developed a topical formulation of its alopecia candidate, FOL-005, the year before. The new formulation is more user-friendly compared to treatments currently available on the market, and, at the beginning of this year, Follicum began a double-blind and placebo-controlled phase IIa clinical trial to optimise the candidate’s maximum dosage and treatment duration without compromising safety.

In March, Follicum announced that the first group of alopecia patients had started treatment in the trial. Despite a short delay in patient recruitment due to the Covid-19 pandemic, Follicum was able to jumpstart the process in June thanks to a partnership with CentroDerm, a study clinic based in Wuppertal, Germany. This collaboration is the third forged by Follicum for conducting the FOL-005 study; the other partners include other reputable clinics specializing in hair loss, the Clinical Research Center for Hair and Skin Science (CRC) at Charité hospital in Berlin and proDerm in Hamburg.

»The Covid-19 pandemic has greatly affected everyone to one extent or another and we at Follicum sympathise with all those impacted. Regarding the company, we are happy to say that despite a pause in the hair study, we have managed to have a good pace in all of our activities. We are also thankful to our shareholders and investors supporting us leading to a successful directed share issues a few weeks ago« — Jan Alenfall, CEO of Follicum

Then, in beginning of October, Follicum announced that all 200 patients, who are all males, had been recruited for the study. This set the stage for the last patient to complete his treatment regimen by the end of January/beginning of February 2021. After finalised treatment, each patient’s hair growth will be evaluated based on differences between post- and pre-treatment in hair density and other parameters, and soon thereafter, during spring 2021, top-line data is expected to be announced.

Capital raise to end the year
Shortly thereafter, Follicum announced it had raised 33.6 million SEK in a directed issue of 14 million new shares after deduction of issue-related costs. The funds are expected to go toward setting up a potential collaboration for moving the hair project into phase IIb. They will also allow the company to advance its preclinical program in diabetes.

CEO gives his take
BioStock got in touch with Follicum’s CEO Jan Alenfall to hear what his impressions are of Follicum’s 2020 and what to expect in the coming year.

Jan Alenfall, most people look back at 2020 and get an unpleasant feeling in their stomach. What is your reaction when you look back at Follicum’s year?
– The Covid-19 pandemic has greatly affected everyone to one extent or another and we at Follicum sympathise with all those impacted. Regarding the company, we are happy to say that despite a pause in the hair study, we have managed to have a good pace in all of our activities. We are also thankful to our shareholders and investors supporting us leading to a successful directed share issues a few weeks ago.

What would you say has been the most exciting news from 2020?
– Managing to include all patients in the hair study more or less according to schedule despite the pandemic is something that we are very happy and proud of! Further, that the FOL-005 formulation appears to be safe and user friendly.

Jan Alenfall, CEO Follicum

Jan Alenfall, CEO Follicum

Have the two patent approvals for the diabetes project already had an impact this year?
– It is very important to achieve granted patents on the major markets as soon as possible. This is a lengthy process but essential to our credibility and to increase the value of the diabetes project.

As you look forward to 2021, top-line data from the phase IIa hair study are expected to be presented in the spring of 2021, which is in line with what has previously been communicated. Do you expect Covid to have an impact on this timeline?
– Germany is currently applying stricter restrictions on freedom of movement due to the pandemic. I am very pleased to say, however, that these restrictions are not expected to have any repercussions on the clinical study of the drug candidate FOL-005 in alopecia patients conducted by Follicum at study centres in Hamburg, Wuppertal and Berlin. This is because most of the 200 patients enrolled for the study have already completed their last visit. The few remaining patients are expected to complete the study as planned at the end of January, after which data processing and analysis will be performed.

Besides the results from the phase IIa study in the hair loss project, what other milestones should we expect from Follicum in 2021?
– We hope that our diabetes project will evolve, resulting in interesting milestones during 2021 and that we can subsequently communicate exiting news.

Finally, do you have a special new year’s resolution for Follicum?
– My resolution will be to continue to deliver according to what we plan – this has been a hallmark of Follicum since the start!

Read the article at Biostock.se

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.