Uppsala, November 14, 2022. Dicot announces today that the first regulatory meeting for LIB-01 prior to an application to start clinical trials has been conducted. This was the first of two planned scientific advisory meetings with the Swedish Medical Products Agency, with the purpose of anchoring the scientific background documentation for a clinical trial application.
Dicot is developing a new potency drug 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 in mid-2023.
As part of the preparation to enter clinical phase, the company has now conducted the first of two planned scientific advisory meetings with the Swedish Medical Products Agency, with the purpose of anchoring the scientific background documentation for a clinical trial application. The scientific advice concerned central parts regarding both manufacturing and pharmacology. The next advisory meeting will focus on the design of the planned clinical trial as well as the toxicological package.
"It is an important milestone for LIB-01 and for Dicot to have completed the first formal regulatory interaction. It was a successful meeting, creating certainty in the continued work towards the planned start of a clinical trial in mid-2023", says Elin Trampe, CEO at Dicot.
For further information, please contact:
Elin Trampe, CEO
Tel: +46 739 80 14 08
Email: 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 those on the market. Today, at least 500 million men suffer from these sexual dysfunctions and the market is valued at SEK 50 billion. Research and development are conducted under own auspices up to phase 2 studies. Thereafter, Dicot's intention is to form strategic alliances, or alternatively carry out a trade sale, with larger, established pharmaceutical companies to be able to introduce LIB-01 on the world market.
Dicot is listed on Spotlight Stock Market and has approximately 3,300 shareholders. For more information, please visit www.dicot.se.