Recruitment completed in Dicot’s phase 1 trial
Press release: Uppsala, Sweden, March 11, 2024. Today, the potency drug developer Dicot announces that the recruitment to the final part of its phase 1 study is completed. The study is thus proceeding according to the previously communicated timeline and the results are expected to be announced during the second quarter.
Dicot's phase 1 study, aiming at investigating the safety profile in humans, started in August 2023 and consists of two parts: SAD (single dose) and MAD (multiple doses). The study is placebo-controlled and double-blind, meaning that some participants receive LIB-01 and some receive placebo, and neither the participant nor the physician knows which of the two was dosed.
In January 2024, Dicot announced the first results from the SAD, which showed that the drug candidate LIB-01 has a very good safety profile. There were no serious side effects, nor were dose increases limited by any side effects.
The MAD includes some 25 participants divided into different dose groups where the dosage is increased between the different groups. Dicot has now recruited the last participant, which means that the study is progressing according to plan. Overall results are expected to be announced in the second quarter of 2024, as previously communicated by the company.
"The fact that the last MAD participant has been enrolled and that the recruitment for the entire study now is completed is another important milestone that we can tick off. Our collaboration with the CRO partner CTC is exemplary, greatly assisting us in constantly being on schedule", 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 5,000 shareholders. For more information, please visit www.dicot.se.