The multiple dose part of Follicum’s clinical phase I / II a study on candidate drug FOL-005, being conducted at the Charité University Hospital in Berlin, is expected to complete in January 2017 rather than before Christmas 2016, as previously announced. This multiple dose part of the study, in which two groups are treated with Follicum’s drug candidate FOL-005 over a three-month period, has been delayed due to change in the timing of visits. This change is not expected to cause any delays in reporting the final results of the study, which is planned for early in 2017.
Status Update on the Phase I/IIa study
Follicum announced in September 2016 that recruitment for the second part of this study was fully enrolled, it has now decided to include two additional participants, to ensure that the treatment group is complete. The two treatment groups now total 32 people.
This multiple dose part of the study is more extensive than the initial part, as each individual patient is being treated for three months.
The study is examining different dosing frequencies, one group is being treated twice per week and the other group three times per week, each person receiving four different doses (plus placebo). This is followed by a period of three months without treatment, to ensure that no side effects occur after treatment is completed. In addition, the possible long-term effects on hair growth will be studied as a follow up. Follicum intends to report the study results as soon as possible.
To date, no serious adverse events related to FOL-005 have been observed.
Completing in January 2017
The objective, as previously announced, was that treatment of all participants would be finished by the end of 2016. Although the study is proceeding according to plan, the treatment timing of a few participants means that treatment of all participants will now be finished in January 2017. The Board of Follicum believes that this will not lead to any delay in completion of the final report from the study, which is planned for early in 2017, as announced previously.
The Company intends to report the results in two stages:
- The first, the treatment period outcome.
- The second, the three-month follow-up, which will be the end of the study results.
Follicum’s ongoing clinical trial is being carried out in accordance with current Good Clinical Practices ( “cGCP”), a strict scientific study model, and the company will not have access to the data until the study is completed.
Comment from the CEO, Jan Alenfall
– The change to the timing of treatment completion, from before the end of 2016 to the beginning of 2017, does not totally change our time plan. This is a minor change, and common in clinical studies. The continued treatment of study participants in Berlin is progressing well, and we are very pleased with the way the study is being run by the clinic.
For further information, please contact:
Jan Alenfall, CEO
Phone: +46 (0) 46 19 21 97
This is information which Follicum is required to disclose under the EU Market Abuse Regulation. The information was provided by the auspices of the above contact person, for publication on November 22, 2016.