The second part of Dicot's phase 1 study starts today
Press release: Uppsala, Sweden, October 20, 2023. In August, the pharmaceutical company Dicot's phase 1 study was initiated, with single dosing of the participants. Concurrently, the second part of the study starts today, where safety of LIB-01 is now being studied with repeated dosing.
Dicot's first clinical study in humans with the potency drug candidate LIB-01 started in August and is in full swing. Initially, participants were administered a single dose, called Single Ascending Dose (SAD). Now, in parallel, the study is moving into next part where new participants receive repeated dosing, also called Multiple Ascending Dose (MAD). Today, the first screening visit takes place to identify participants for the MAD part's first dose group. The screening means that applicants are examined based on a variety of selection criteria for participation in the study.
As the company previously announced, this is a placebo-controlled phase 1 clinical trial with the primary objective to evaluate the safety profile of LIB-01 in humans. The entire study is double-blinded, which means that some participants receive LIB-01 and some receive a placebo, and that neither the participant nor the physician knows which of the two was dosed.
"The study is progressing according to plan and the fact that the MAD part now can run in parallel to the last dose groups in the SAD is a modern, efficient way to conduct the research. Dosing of participants continues into next year and we expect the first results from the study to be released during spring 2024," says Elin Trampe, CEO of Dicot.
For further information, please contact:
Elin Trampe, CEO
Phone: +46 72 502 10 10
E-mail: elin.trampe@dicot.se
About Dicot AB
Dicot 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 studies and thereafter in partnership with larger, established pharmaceutical companies, finance and develop LIB-01 further to a registered pharmaceutical on the world market.
Dicot is listed on Spotlight Stock Market and has approximately 4,400 shareholders. For more information, please visit www.dicot.se.