Dicot Pharma has announced the initiation of its Phase 2a clinical study for LIB-01, a drug candidate aimed at treating erectile dysfunction (ED). The trial, a double-blind, placebo-controlled study, seeks to evaluate the efficacy of LIB-01 in patients suffering from ED. The study has commenced following approval from relevant authorities.
The Phase 2a study will enroll 140 male participants across six clinics located in Sweden, Denmark, and the Netherlands. Each participant will be involved for eight weeks after the initial dose. The study design ensures that neither the clinical staff nor the participants know who is receiving LIB-01 versus the placebo.
"The team at Dicot Pharma is both proud and happy that everything went as planned with setting up the study and that we have been able to start so quickly after receiving approval from the relevant authorities," said Elin Trampe, Dicot Pharma’s CEO. She also noted the high interest from individuals looking to participate, reflecting confidence in Dicot's work.
The clinical phase of the study is anticipated to continue until mid-2025, after which a statistical analysis will be conducted to determine the results. LIB-01 is being developed as a potency agent with the goal of providing a longer effect and fewer side effects compared to currently available treatments for erectile dysfunction and premature ejaculation. Dicot Pharma estimates that over 500 million men worldwide suffer from these sexual dysfunctions, representing an $8 billion market.
Dicot Pharma intends to develop LIB-01 through Phase 2a trials and then partner with larger pharmaceutical companies to finance further development and registration of the drug for global markets.
