For Follicum, one of this year’s main events will be the topline result from the ongoing phase IIa study with the company’s candidate FOL-005 for treatment of hair loss. The company announced on Thursday that all patients in the study have undergone treatment and that results are expected in the spring. BioStock talked to Follicum’s CEO Jan Alenfall to find out more.
Despite the pandemic, Lund-based Follicum was, in October last year, able to complete patient recruitment for the phase IIa study in its most advanced project FOL-005, a topical treatment for hair loss. The study is carried out over four months and topline results regarding the safety and efficacy of FOL-005 in the patient group will be expected during the spring. In case of positive data, the company intends to establish a partnership for further clinical development and commercialisation. See CEO Jan Alenfall talk more about the strategy in a previous interview with BioStock.
All patients have completed the treatment
In two previous clinical studies, Follicum has shown that intradermal injections of the candidate have been both effective and safe. In the current phase IIa study, patients have applied FOL-005, a cream-like substance, in one of three different strengths once a day for four months. They have then undergone follow-up on regular visits to one of the three German clinics included in the study.
The company announced on Thursday that all of the more than 200 patients included in the study have completed their treatment. According to Follicum, no relevant adverse reactions have been reported so far and only one patient has discontinued treatment, as an effect of the Covid-19 pandemic. Review and analysis of the results is now ongoing, and topline data is expected to be presented during spring.
BioStock contacted Follicum’s CEO Jan Alenfall to learn more about the company’s activities while waiting for the topline results.
Jan, all patients have now concluded treatment in your phase II study with FOL-005. What does this mean for the development of FOL-005?
– The fact that the active part of the study has been completed is a very significant milestone. This means that all data to be processed and analysed is now secured. We therefore no longer need to worry about any further repercussions of the corona pandemic on the implementation of the study.
– We are of course extremely pleased that all but one patient were able to complete the treatment. Moreover, this single so-called drop-out was a consequence of travel restrictions due to the pandemic. Now we can stick to the schedule that we set up and thus we expect to communicate top-line data in the spring.
Now the study will be un-blinded and analysed. What do you expect from the results?
– First of all, I hope that the analysis shows that the safety of the product is as good as in previous studies, and we already know that no relevant side effects have been reported, which is very positive. In addition, I hope that we can show good effect on the parameters of hair growth, in line with what we have seen in the previous clinical studies.
Many companies have been affected by the ongoing Covid-19 pandemic. However, your phase II study has so far not been significantly affected. Based on the current situation in Europe, how do you think the pandemic will affect your activities in 2021?
– We can say that we have made it through the most critical part of the study. Future activities are less affected by the pandemic than the active part of the clinical study was, as the data management and analysis can largely be carried out by working from home.
– For our other activities and projects, we and most of our partners have been able to keep these going, and the few who had to close down are now planning to reopen gradually in the coming weeks. Fortunately, we have been able to redirect our planning so that we have only been minimally affected by the pandemic, and for that we are extremely grateful. Therefore, we see no need to make any major adjustments to follow our previous plans. Like everyone else, we now look forward to Covid vaccination contributing to the gradual return of activity and for society at large to return to the normal.
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