Dicot starts production of LIB-01 for human trials
Press release: Uppsala, March 4th, 2021. The potency drug developer Dicot has started a new production of the drug candidate LIB-01. The batch will be used for the phase 1 human clinical trials starting in 2022.
Dicot has just started a new production of the extract to be used for the drug candidate LIB-01. This is done in collaboration with Ardena in Södertälje, which is a certified CDMO (Contract Development & Manufacturing Organization). Ardena is an expert in managing the development and production of drug candidates and has, among other things, cutting-edge expertise in nano-medicine.
The raw material contains seeds from the fruits of African trees. The seeds are first ground and thereafter Ardena produces an extract. This is sent to Anthem Biosciences in India, who converts the substances in the extract in a semi-synthesis to be used in the LIB-01 drug candidate.
The batch will be used during phase 1 clinical trials in humans, which will begin in 2022. Therefore, the safety requirements for production are very high and carried out in accordance with GMP (Good Manufacturing Practice).
"This batch is an important step in our development plan and a clear marker of the industrialization phase which we have entered. To be able to physically see the extract that Ardena produces makes the project very concrete and signals that we are getting even closer to the clinical trials ”, says Göran Beijer, CEO of Dicot.
For further information, please contact:
Göran Beijer, CEO
Phone: +46 (0) 706 63 60 09
About Dicot AB
Dicot is developing the drug candidate LIB-01 (formerly Libiguin), 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 1 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 1,800 shareholders. For more information, please visit www.dicot.se