Successful meeting with Swedish MPA strengthens Dicot's clinical trial application
Uppsala, March 28, 2023. Dicot has now conducted the last of two planned regulatory meetings prior to an application to start clinical trials. The purpose was to anchor the scientific background documentation to be included in a clinical trial application and covered central parts of Dicot’s study design to which the Swedish Medical Product Agency was positive.
Dicot is developing a new potency medicine that aims to become the first choice for the treatment of erectile dysfunction and premature ejaculation. The company plans to start clinical trials with the drug candidate LIB-01 during mid-2023.
As part of the preparations to start a clinical phase 1 trial, the company has now conducted the last of two planned scientific advisory meetings with the Swedish MPA, with the purpose of anchoring the scientific background documentation for a clinical trial application. The first meeting covered the manufacturing and pharmacology. The final meeting focused on the design of the clinical trial as well as the toxicology program. The questions that Dicot raised included the general design of the study, the number of study participants and the starting dose. The MPA was positive towards all the company's proposals.
"We have now had two well-prepared meetings with the Swedish Medical Products Agency, which turned out very well. These authority interactions play an important part of the development work and it creates a good foundation for a successful trial application," says Elin Trampe, CEO at Dicot.
For further information, please contact:
Elin Trampe, CEO
Phone: +46 739 80 14 08
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 7 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 4,000 shareholders. For more information, please visit www.dicot.se.