The drug candidate LIB-01
LIB-01 is being developed into a new pharmaceutical product on the world market that treats erectile dysfunction and premature ejaculation better than currently available drugs.
The nonclinical development program was completed during the spring 2023 and the first clinical trial of LIB-01 in humans started in August 2023. Dicot's now completed phase 1 clinical study demonstrates that LIB-01 has a very good safety profile, which was the primary objective of the study. In addition to this, an efficacy signal from the study was captured as participants reported an improved erectile function and that the effect lasted during four weeks.
At the end of 2024, the company began a phase 2a trial with the aim of giving LIB-01's effect on erectile function statistical significance. The clinical part of the study is expected to last until the middle of 2025. A statistical analysis will then follow before the results can be reported.
"Our goal is to develop a completely new generation of potency drugs with a long duration of action and without any disturbing side effects. These results clearly demonstrate that we are moving towards that goal, which would make a big difference for affected men and couples".
CEO Elin Trampe.
Within the LIB-01 development program, process development and manufacturing scale-up are also carried out to ensure availability of the drug substance. The drug substance together with a formulation, constitute the drug product that is used in the clinical trials.