Uppsala, Sweden, November 8, 2024. After recently receiving approval from authorities, the potency drug developer Dicot Pharma's clinical phase 2a study has now started. The primary objective of the study is to evaluate the efficacy of LIB-01 in patients with erectile dysfunction.
Recruitment for the phase 2a study began immediately after the authority's approval and is managed by the company's clinical partner CTC, which is conducting the study. Now the company announces that the study has formally started as the first screening visit has taken place.
The primary objective of the phase 2a study is to evaluate LIB-01's efficacy in patients with erectile dysfunction. The study will enroll 140 male participants and will be conducted at six clinics across Sweden, Denmark and the Netherlands.
Each patient will participate for eight weeks after initial dosing. The study is double-blind, and placebo controlled, meaning that that neither the clinical staff who administer the study drug nor the participants will know which research subjects are receiving LIB-01 and which are receiving placebo.
As Dicot Pharma previously announced, 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.
"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. Recruitment of study participants often delays the start of clinical trials; however, we have noted great interest from individuals looking to participate in our phase 2a study. This not only gives us confidence for an effective study execution, but also serves as a reflection and endorsement of the work Dicot is doing to combat erectile dysfunction," said Elin Trampe, Dicot Pharma's CEO.
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 Pharma'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 Nasdaq First North and has approximately 7,200 shareholders. FNCA Sweden AB is appointed Certified Adviser. For more information, please visit www.dicotpharma.com.
This is a translation from the Swedish original. In case of differences between versions, the Swedish version prevails.