Follicum pauses recruitment of patients in Phase II clinical trial of FOL-005 as a result of the ongoing COVID-19 pandemic
Follicum AB ("Follicum" or "the company") today announces that the company has decided to temporarily suspend the phase II study of the drug candidate FOL-005 recently initiated in Germany. This is due to government recommendations in Germany in light of the ongoing outbreak of COVID-19. The company intends to resume the recruitment of patients for the study as soon as the situation in Germany improves.
Follicum's Phase II study of FOL-005 was initiated on March 9, 2020 and the recruitment of patients has so far progressed well. The study is being conducted at the Clinical Research Center for Hair and Skin Science in Berlin and at proDERM in Hamburg and is planned to comprise a total of approximately 200 men with hair loss. The patients themselves will apply a cream with three different strengths of FOL-005 or placebo for four months. The original plan was to present the study results at the end of 2020. The company will continue its close dialogue with the clinical sites and follow recommendations from the German Authorities and take appropriate measures to minimize any delay that may be caused by the study break.
CEO Jan Alenfall comments:
"Given the burden on health care and the restrictions on freedom of movement in much of Europe, the German Authorities’ desire to not prioritize resources for clinical trials is perfectly natural. Although the decision to suspend the Phase II study of FOL-005 will certainly cause a delay in the project, we do not believe that this affects its potential in the longer term. "
FOL-005 is a modified, short version of the endogenous protein, osteopontin. In two completed clinical studies, treatment with FOL-005 has been shown to be effective and safe. The first study was done in healthy volunteers while the other one was conducted in alopecia patients, i.e. in men with incipient baldness. In both studies, patients were treated at the clinic with intradermal injections, 2 or 3 times a week.
Alopecia means hair loss. This may be due to a number of causes. The most common form is called Androgenic Alopecia or male hair loss and affects the majority of all men but also a very large proportion of women. It is by far the most common form of hair loss. It is known that high levels of and high sensitivity to a sex hormone called dihydrotestosterone (DHT) leads to an increased risk of hair loss in men and women. Simply put, it can be said that the hormone causes the hair follicles to shrink and no longer produce a pigmented hair.
For further information, please contact:
Jan Alenfall – CEO, Follicum AB
Telephone: +46 46 19 21 97
This information is information that Follicum is obliged to make public according to the EU Market Abuse Regulation. The information was provided through the agency of the contact persons above, for publication on the 18th of March, 2020.
About the Clinical Research Center for Hair and Skin Science (CRC), Berlin, Germany
The Clinical Research Center for Hair and Skin Science ("CRC") is part of the skin clinic at the Charité - University Hospital in Berlin. CRC conducts experimental research and offers specialist expertise in the area of skin and hair research. CRC has conducted several clinical studies in various hair indications and has solid qualifications with specialization in Phase I and II clinical studies.
proDERM is a full-service contract research organization in Hamburg, Germany, specializing in conducting clinical studies in the areas of skin, mucosa, hair, eyes and mouth. proDERM carry out studies on medicinal products, medical devices, cosmetics, nutritional supplements and consumer goods alike, and competently comply with the various regulatory and legal requirements. proDERM is a competent, full-service partner, supervising clinical projects in all phases.
About Follicum AB
Follicum is a biotech company focused on the discovery and development of peptide-based drugs. The primary focus is in hair growth stimulation, where Follicum has obtained very promising results with FOL-005 in a recently completed clinical trial. In diabetes, Follicums research has resulted in a new peptide class which significantly increases the release of insulin in pre-clinical models. The company was founded in 2011, and is based in Lund, Sweden. Follicum is listed on the Swedish small cap exchange Spotlight since 2014. www.follicum.com.