Follicum develops innovative peptide-based drugs with the lead candidate FOL-005 against alopecia, or unwanted hair loss, popularly known as “baldness”. The candidate has undergone a preclinical program and two clinical studies, all of which indicate that the candidate stimulates hair growth in combination with a good safety profile.
The first clinical study included healthy volunteers, while the second was conducted in men with incipient baldness. In both studies, FOL-005 was administered by intradermal injections in the clinic 2 or 3 times a week. Since then, Follicum has developed a cream-like topical formulation with appealing ease of use that is now undergoing a placebo-controlled phase IIa study in alopecia patients. The current study aims to investigate the safety, efficacy and treatment response of the topical formulation of FOL-005.
Patient recruitment is gaining momentum
The study was initiated in the spring and in March the company was able to announce that the first group of patients had started treatment. The goal is for the study to include a total of 200 male patients and be conducted at well-established clinics in Germany. However, as a result of the Covid-19 pandemic, and an increased need for care in other healthcare segments, patient recruitment was temporarily stopped in the spring and then resumed in early June. See Follicum's CEO Jan Alenfall tell me more here.
Initially, the idea was to conduct the study at the Clinical Research Center for Hair and Skin Science (CRC) in Berlin and at proDerm in Hamburg. When patient recruitment resumed in June, the CentroDerm in Wuppertal – another well-reputed German study clinic with experience in similar studies – with the aim of increasing the recruitment rate.
The effort has now borne fruit as Follicum was able to announce that it has now reached the milestone of recruiting over 50 percent of the intended patient group in the phase IIa study. This means that the study is on track and the company expects to be able to share study results in the spring of 2021.
Comments from the CEO
In a press release, Jan Alenfall expressed his satisfaction with the announcement:
»The fact that more than half of the patients have now been recruited is an important milestone for Follicum. We are very pleased to be one of the few pharmaceutical companies not to have suffered significant delays in an ongoing study due to the Covid-19 pandemic. We are following the planned recruitment pace after a temporary pause in the study and are working intensively to achieve the recruitment target so that the patients can be completed before the end of the year. The current study aims to confirm the interesting results that we have seen in previous studies, now in a larger patient group and with the cream-like formulation that has been developed and tested over the past year.«
The content of BioStock's news and analysis is independent, but BioStock's operations are to some extent financed by companies in the industry. This post refers to a company from which BioStock has received funding.