Reporting from Dicot's phase 1 study end of April
Press release: Uppsala, April 5, 2024. Yesterday, Dicot completed the clinical phase of the second and final part of its phase 1 study. The company can thus confirm that the reporting from this part of the study will be published at the end of April, followed by an in-depth summary of results for the entire phase 1 study later in the second quarter.
Dicot's Phase 1 study of the potency drug candidate LIB-01 is placebo-controlled and double-blind with the primary objective to investigate the safety profile in humans. It started in August last year and consists of two parts: single doses (SAD) and multiple doses (MAD). In January this year, Dicot presented positive results from the first part with single dosing where LIB-01 showed a very good safety profile without serious adverse effects. The results also showed that the drug is well absorbed in the body.
Yesterday, the last study participant in the MAD part completed his final clinic visit. This means that all participants have been dosed and undergone the subsequent safety follow-up. Now a period of data compilation remains before locking the database. Dicot has previously announced that results from the MAD part will be available during the second quarter of 2024, which can now be confirmed. The initial reporting is scheduled for the end of April. An in-depth summary of results for the entire Phase 1 study will be presented later in the second quarter.
"We can now communicate more specific timelines for reporting of the MAD part and thus confirm that we will keep the timetable for the phase 1 trial. Now that all participants have completed all clinical visits, we know when the database can be locked, thus establishing the timing for the initial reporting", comments Dicot's CEO Elin Trampe.
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 5,300 shareholders. For more information, please visit www.dicot.se.