Dicot confirms planned start date in August for its phase 1 study
Press release: Uppsala, August 14, 2023. The potency drug developer Dicot announces that the decision from the Swedish Medical Products Agency on the clinical trial application is expected within two weeks and that the company is ready to start the study in August according to the previously communicated schedule.
Dicot has completed all preparations required for the start of the planned phase 1 trial of its potency drug candidate LIB-01. The round of questions with the Medical Products Agency and the Ethical Review Authority, which is part of the application process, was completed during July, and Dicot expects to receive final decision on its trial application within two weeks.
The study to be conducted is a placebo-controlled phase 1 clinical trial with the primary objective to evaluate LIB-01's safety profile in humans. Screening of participants begins as soon as an approval is in place, followed by dosing of the first dose group.
"We have worked very intensively during the past months and are happy to state that we are on track with the schedule. The summer's round of questions went very well so we see no obstacles to a positive reply from the Medical Products Agency and we are ready to start as soon as an approval comes," comments Elin Trampe, CEO of Dicot.
For further information, please contact:
Elin Trampe, CEO
Phone: +46 73 980 1408
E-mail: [email protected]
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.
Dicot utvecklar ett modernt potensläkemedel som ska behandla erektionssvikt och för tidig utlösning bättre än befintliga preparat.