First participants dosed in Dicot Pharma's Phase 2a clinical study
Uppsala, Sweden, November 20, 2024. The first participants in Dicot Pharma's Phase 2a clinical study have now been dosed. The company's drug candidate LIB-01 is being developed as a new first-line treatment for erectile dysfunction.
Dicot Pharma has recently started its Phase 2a clinical study with the potency drug candidate LIB-01. The purpose of the study is to evaluate the efficacy of LIB-01 in men with erectile dysfunction. The first participants in the study have now been dosed, at sites in Stockholm and Gothenburg. All participants will be dosed for three consecutive days and then followed for eight weeks to monitor efficacy and safety. Recruitment is ongoing throughout the clinical phase of the study.
"Now we are underway! The first participants have been dosed and the 2a-study is now entering an intensive period. This study is an important milestone that will bring us closer to the launch of a whole new generation of potency drugs," says Dicot Pharma's CEO Elin Trampe.
About the phase 2a study
The purpose of the Phase 2a study is to evaluate the efficacy of LIB-01 in men with erectile dysfunction. The study is expected to include 140 participants and is being conducted at six clinics in Sweden (Uppsala, Stockholm, Gothenburg and Linköping), Denmark (Herlev) and the Netherlands (Groningen). Each person will participate in the study for eight weeks after dosing. The trial is double blind and placebo controlled. This means that neither the clinical staff administering the study drug, nor the participants, know which research subjects are receiving LIB-01 and which are receiving placebo. The clinical part of the study is expected to last until mid-2025. This will be followed by a statistical analysis before the results can be reported.