Dicot Pharma receives approval to start Phase 2a clinical trial

Uppsala, Sweden, October 21, 2024. Today, the pharmaceutical company Dicot Pharma was granted authorization to start its clinical phase 2a study which will be conducted in Sweden, Denmark, and the Netherlands. It is a placebo-controlled trial with the primary objective to evaluate the efficacy of the potency drug candidate LIB-01 in patients with erectile dysfunction.

Dicot Pharma's second study in humans with the potency drug candidate LIB-01 has now received regulatory authorization from all relevant authorities in Sweden, Denmark, and the Netherlands. Preparations for the study are completed, and participant screening will soon begin, followed by dosing.

It is a placebo-controlled phase 2a clinical trial with the primary objective to evaluate the efficacy of LIB-01 in patients with erectile dysfunction. 140 patients will be participating in the study, conducted at six clinics in three countries. The patients will be monitored for efficacy and safety over an eight-week period. The CRO responsible for the study is Clinical Trial Consultants, who were also responsible for LIB-01´s phase 1 study.

The regulatory approval means that Dicot Pharma can start the study according to the previously communicated timetable. The company anticipates that the clinical phase of the study will continue until mid-2025. This will be followed by a statistical analysis before the results can be reported.

For further information, please contact:

Elin Trampe, CEO
Phone: +46 72 502 10 10
E-mail: elin.trampe@dicotpharma.com

About Dicot Pharma AB

Dicot Pharma is developing the drug candidate LIB-01, which will be a potency agent to better treat erectile dysfunction and premature ejaculation. The ambition is to create a drug with significantly longer effect and far fewer side effects, compared to current available drugs. Today, over 500 million men suffer from these sexual dysfunctions and the market is valued at USD 8 billion. Dicot's strategy is to develop LIB-01 under own auspices until phase 2a study and thereafter in partnership with larger, established pharmaceutical companies, finance and develop LIB-01 further to a registered pharmaceutical on the world market.

Dicot Pharma is listed on Spotlight Stock Market and has approximately 7,200 shareholders. For more information, please visit www.dicotpharma.com.